Bruno, M.J.

Clinical outcome of progressive stenting in patients with anastomotic strictures after orthotopic liver transplantation (Article)

2013-04-12T00:00:00Z

Background and study aims: Anastomotic strictures are an important cause of morbidity after orthotopic liver transplantation (OLT). Endoscopic treatment is the primary treatment modality for biliary complications after OLT. The outcome and complications of a progressive stenting protocol are largely unknown. Patients and methods: A longitudinal cohort study of OLTs was conducted. Only patients with late strictures were included. Treatment success was defined as cholangiographic stricture resolution and liver enzymes returning to normal with follow-up of at least 12 months. Results: Between May 2000 and June 2009, 375 OLTs were performed. A duct-to-duct anastomosis was created in 304 cases (81 %). In 63 patients (21 %; 95 % confidence interval [CI] 16.5 % - 25.6 %) an anastomotic stricture developed and progressive stenting was started in 35. During treatment two patients died of a non-treatment-related cause and two patients underwent a second OLT during stent therapy. Therefore 31 patients were available for analysis (male: female 21:10; median age 61 years, range 28 - 75 years). Progressive stenting required a median number of 5 endoscopic retrograde cholangiopancreatography (ERCP) procedures (range 4 - 11). A median maximum of 4 stents (range 2 - 8) were inserted. A total of 21 patients (67.7 %; 95 %CI 50.1 % - 81.4 %) developed a treatment-related complication. In 33 out of a total of 155 ERCPs (21.3 %) a complication occurred: cholangitis (n = 12), transient cholestasis (n = 11), post-ERCP pancreatitis (n = 7), and treatment-related pain (n = 3). The median follow-up time after stent removal was 28 months (range 12 - 92). Treatment was successful in 25 patients (80.6 %; 95 %CI 63.7 % - 90.8 %). Conclusion: Progressive stenting for anastomotic strictures after OLT is demanding and burdensome, necessitating a median of 5 ERCP procedures with complications occurring in one out of five procedures. Its success rate however is high (81 %), avoiding surgery in the large majority of patients.

The prevalence of fat-soluble vitamin deficiencies and a decreased bone mass in patients with chronic pancreatitis (Article)

2013-03-18T00:00:00Z

Background/objectives: In chronic pancreatitis, malabsorption of fat is common due to loss of exocrine function. Consequently, these patients are at risk to acquire deficiencies of the fat-soluble vitamins, which may result in a decreased bone mineral density (BMD) and the development of osteopenia and osteoporosis. Methods: We prospectively enrolled all patients diagnosed with chronic pancreatitis, who visited our outpatient clinic between March and November 2011. Data were collected regarding demographic characteristics, symptoms, and pancreatic function. Serum concentrations of vitamins A, E, K, and D were determined, and BMD was assessed by means of bone densitometry. Results were analyzed according to pancreatic function status and enzyme use, and compared to reference data, when available. Results: Forty patients were included (43% female; mean age of 52). Alcohol abuse was the major cause of pancreatitis (50%). Twenty-eight patients were exocrine insufficient (70%), of whom 19 used pancreatic enzymes. Vitamin A, D, E, and K deficiencies were present in 3, 53, 10, and 63% of patients, respectively. Osteopenia and osteoporosis were observed in 45% and 10% of patients. A decreased BMD was more frequently observed than expected, based on reference data, even in exocrine sufficient patients. Conclusions: Deficiencies of fat-soluble vitamins and a decreased BMD are frequently present in chronic pancreatitis, even in exocrine sufficient patients. Consequently, all patients with chronic pancreatitis should be routinely screened for fat-soluble vitamin deficiencies and a decreased BMD.

Interobserver agreement among pathologists regarding core tissue specimens obtained with a new endoscopic ultrasound histology needle; a prospective multicentre study in 50 cases (Article)

2013-03-01T00:00:00Z

Aim: To evaluate the interobserver agreement among pathologists in grading the quality of specimens obtained with a new 19-gauge endoscopic ultrasound histology needle. Methods and results: This multicentre prospective study involved 50 slides prepared using material obtained with the new needle. Five experienced pathologists independently reviewed all of the samples, and made assessments of the following features: the presence of a core, the adequacy of the specimen, the interpretability of the specimen, and the possibility of performing additional analyses using the material. Interobserver agreement, determined by Fleiss' kappa statistic and 95% confidence intervals (CIs), was used as the primary outcome measure. Overall, the presence of a core was reported in 88% of cases with good agreement among the pathologists (κ = 0.61; 95% CI 0.52-0.70). The specimens were adequate in 91.2% of cases, and Fleiss' κ was 0.73 (95% CI 0.61-0.81). The interpretation of the specimens was reported to be 'easy' in approximately 87% of cases, with moderate agreement among the pathologists (κ = 0.44; 95% CI 0.35-0.53). The possibility of performing additional analyses from the same sample was rated as positive in approximately 91%, with good agreement (κ = 0.66; 95% CI 0.58-0.75). Conclusions: There was excellent interobserver agreement among pathologists in the assessment of the histological material, especially with regard to sample adequacy.

Early diagnosis of pancreatic cancer; Looking for a needle in a haystack? (Article)

2012-09-18T00:00:00Z

Accuracy of preoperative workup in a prospective series of surgically resected cystic pancreatic lesions (Article)

2012-09-01T00:00:00Z

Background. Magnetic resonance imaging (MRI) and endoscopic ultrasound (EUS) are considered useful techniques in the evaluation of pancreatic cysts. Aim of this study was to prospectively compare the diagnostic value of these techniques. Methods. This study included consecutive patients who underwent MRI, EUS, and EUS-FNA for a pancreatic cyst that was eventually resected surgically. Observers scored for cyst characteristics, a distinction between mucinous and non-mucinous cysts and a suspicion of malignancy. The interobserver agreement between MRI and EUS was calculated. Results. A total of 32 patients were included. Sensitivity for diagnosing a mucinous cyst was 78% for EUS versus 91% for MRI. Sensitivity for detecting malignancy was 25% (1/4) and 50% (2/4) for EUS and MRI respectively. Sensitivity of EUS-FNA for diagnosing a mucinous cyst (positive cytology and/or CEA >192 ng/ml) was 61%. Sensitivity for detecting malignancy (positive cytology) was 1/4 (25%). Interobserver agreement between MRI and EUS for the features was poor to fair. Conclusion. MRI and EUS are comparable techniques for the morphological characterization of pancreatic cysts. Combined sensitivity of EUS and MRI was higher than the sensitivity of one of the techniques alone. For diagnosing a mucinous cyst, FNA findings showed a low sensitivity, but a high specificity.

Pancreatic cancer: Promise for personalised medicine? (Article)

2012-05-01T00:00:00Z

Pancreatic cancer has an infaust prognosis and is the fourth commonest cause of cancer related death in men. Design of rational treatment has been hampered by lack of insight into the pathogenesis of the disease. Recently more insight has been gained into a number of crucial aspects of pancreatic carcinogenesis, in particular the cell types that can give rise to oncological transformation in the pancreas, different modes of interaction between transformed pancreatic cells and the stroma that fosters further disease progression, the need of the pancreatic tumour cells to overcome the pressure of immune surveillance and the various changes in intercellular biochemistry that tumour cells employ to both sustain chemoresistance and metastasis. Although still largely incomplete, this new knowledge opens novel avenues on more successful treatment of the disease through personalised medicine.

Acute pancreatitis and concomitant use of pancreatitis-associated drugs (Article)

2011-12-01T00:00:00Z

Objectives: Drug-induced pancreatitis (DIP) is considered a relative rare disease entity, perhaps due to lack of recognition. The objective of this study was to evaluate the prevalence of pancreatitis-associated drugs in a Dutch cohort of patients admitted for acute pancreatitis (AP) and to identify the proportion AP possibly attributable to the use of drugs. Methods: This was a multicenter observational study (EARL study). Etiology, disease course, use of pancreatitis-associated drugs at hospital admittance, and discontinuation of these drugs were evaluated. Drugs were scored by means of an evidence-based DIP classification system. Results: The first documented hospital admissions of 168 patients were analyzed. In all, 70 out of 168 (41.6%; 95% confidence interval (CI): 34.5-49.2%) patients used pancreatitis-associated drugs at admission. In 26.2% (44/168; 95% CI: 20.1-33.3%) of cases, at least one class I pancreatitis-associated drug was used. Possibly DIP was present in 12.5% (21/168; 95% CI: 8.3-18.4%); in less than half of these patients (9/21 or 42.9%; 95% CI: 24.5-63.5%), the prescribed drugs were actually discontinued, with no recurrence of AP later on. Among the remaining 12 patients without discontinuation of their drugs use and in absence of an alternative etiologic cause of AP, 8 patients used a class I pancreatitis-associated drug, representing 4.8% (8/168, 95% CI: 2.4-9.1%) of the total study population. Conclusions: In this series, a remarkably high percentage of patients who were admitted because of an attack of AP used pancreatitis-associated drugs. Physicians should be more aware of the possibility of DIP in patients with otherwise unexplained AP and act appropriately by discontinuation of the drug.

Feasibility of a pancreatic cancer surveillance program from a psychological point of view (Article)

2011-12-01T00:00:00Z

PURPOSE:: The success of any surveillance program depends not solely on its technological aspects but also on the commitment of participants to adhere to follow-up investigations, which is influenced by the psychological impact of surveillance. This study investigates the psychological impact of participating in a pancreatic cancer surveillance program. METHODS:: High-risk individuals participating in an endoscopic ultrasonography-magnetic resonance imaging-based pancreatic cancer surveillance program received a questionnaire assessing experiences with endoscopic ultrasonography and magnetic resonance imaging, reasons to participate, psychological distress, and benefits and barriers of surveillance. High-risk individuals were individuals with a strong family history of pancreatic cancer or carriers of pancreatic cancer-prone gene mutations. RESULTS:: Sixty-nine participants (85%) completed the questionnaire. Surveillance was reported as "very to extremely uncomfortable" by 15% for magnetic resonance imaging and 14% for endoscopic ultrasonography. Most reported reason to participate was that pancreatic cancer might be detected in a curable stage. Abnormalities were detected in 27 respondents, resulting in surgical resection in one individual and a shorter follow-up interval in five individuals. Surveillance outcomes did not influence cancer worries. Overall, 29% was "often" or "almost always" concerned about developing cancer. Six respondents (9%) had clinical levels of depression and/or anxiety. According to 88% of respondents, advantages of surveillance outweighed disadvantages. CONCLUSIONS:: Although endoscopic ultrasonography is more invasive than magnetic resonance imaging, endoscopic ultrasonography was not perceived as more burdensome. Despite one third of respondents worrying frequently about cancer, this was not related to the surveillance outcomes. Anxiety and depression levels were comparable with the general population norms. Advantages of participation outweighed disadvantages according to the majority of respondents. From a psychological point of view, pancreatic cancer surveillance in high-risk individuals is feasible and justified. Copyright

Long-term outcomes of endoscopic vs surgical drainage of the pancreatic duct in patients with chronic pancreatitis (Article)

2011-11-01T00:00:00Z

Background & Aims: A randomized trial that compared endoscopic and surgical drainage of the pancreatic duct in patients with advanced chronic pancreatitis reported a significant benefit of surgery after a 2-year follow-up period. We evaluated the long-term outcome of these patients after 5 years. Methods: Between 2000 and 2004, 39 symptomatic patients were randomly assigned to groups that underwent endoscopic drainage or operative pancreaticojejunostomy. In 2009, information was collected regarding pain, quality of life, morbidity, mortality, length of hospital stay, number of procedures undergone, changes in pancreatic function, and costs. Analysis was performed according to an intention-to-treat principle. Results: During the 79-month follow-up period, one patient was lost and 7 died from unrelated causes. Of the patients treated by endoscopy, 68% required additional drainage compared with 5% in the surgery group (P = .001). Hospital stay and costs were comparable, but overall, patients assigned to endoscopy underwent more procedures (median, 12 vs 4; P = .001). Moreover, 47% of the patients in the endoscopy group eventually underwent surgery. Although the mean difference in Izbicki pain scores was no longer significant (39 vs 22; P = .12), surgery was still superior in terms of pain relief (80% vs 38%; P = .042). Levels of quality of life and pancreatic function were comparable. Conclusions: In the long term, symptomatic patients with advanced chronic pancreatitis who underwent surgery as the initial treatment for pancreatic duct obstruction had more relief from pain, with fewer procedures, than patients who were treated endoscopically. Importantly, almost half of the patients who were treated with endoscopy eventually underwent surgery.

Breaking the barrier: using extractable fully covered metal stents to treat benign biliary hilar strictures (Article)

2011-08-08T00:00:00Z

Background: Most benign biliary strictures nowadays are managed endoscopically with plastic stents or with a insertion of a fully covered self-expandable metal stent (fcSEMS). The paradigm for the treatment of benign hilar strictures precludes the use of an fcSEMS because it obstructs the intrahepatic bile ducts, in particular, the contralateral hepatic duct. It is unknown whether use of a plastic stent in the opposite hepatic duct after deployment of an fcSEMS across the liver hilum provides an adequate solution for this problem. Objective: To evaluate the use of an fcSEMS in combination with a contralateral plastic stent in the treatment of benign hilar strictures. Design: Case series. Setting: Tertiary referral hospital. Patients: Two consecutive patients with benign hilar strictures. Interventions: Placement of an intrahepatically deployed fcSEMS in conjunction with a contralateral 10F plastic stent for 4 to 5 months followed by stent removal and cholangiogram. Main Outcome Measurements: Clinical and laboratory follow-up of at least 9 months. Results: In both patients, the indwelling period of the stents was uneventful as was stent removal. Both strictures resolved, and there were no clinical or biochemical signs of a recurrent stricture. Limitations: Small number of patients. Conclusions: Treatment of benign hilar strictures with an fcSEMS deployed across the liver hilum in conjunction with a contralateral plastic stent placement is feasible without ensuing cholangitis caused by bile duct occlusion.

Use of early CT scanning in patients with acute pancreatitis (Article)

2011-08-01T00:00:00Z

Interobserver agreement for endosonography in the diagnosis of pancreatic cysts (Article)

2011-06-30T00:00:00Z

Background and study aims: Endosonography is considered a valuable technique in the evaluation of pancreatic cysts. The aim of the present study is to assess interobserver agreement, in three different observer groups, regarding EUS for characterization of pancreatic cysts. Patients and methods: Video sequences of 40EUS procedures for pancreatic cysts were prepared. Three groups of observers had different levels of EUS experience: group 1 comprised four experts with extensive EUS experience, group 2 had four semi-experts with limited EUS experience, and group 3 (novices) comprised four non-expert resident physicians without EUS experience. Features scored included septations, nodules, solid components, and pancreatic duct communication. A presumptive diagnosis had to be specified. The intraclass correlation coefficient (ICC) was used, with agreement classed as excellent (>0.80), good (0.610.80), moderate (0.410.60), fair (0.200.40), and poor (<0.20). Results: Agreement regarding nodules was good among experts (ICC 0.65) and fair in the semi-expert and novice groups (ICC 0.32 and 0.37, respectively). For presence of solid components there was significantly higher agreement among experts (ICC 0.52) compared with the other two groups (semi-experts 0.09, and novices 0.03). Agreement regarding specific diagnosis was moderate in the expert group (0.43), poor among the semi-experts (0.09), and fair among the novices (0.30). Conclusions: Interobserver agreement among expert endosonographers was mostly moderate for characteristics of pancreatic cysts. However, interobserver agreement for experts was equal to or higher than that in the semi-expert and in the novice groups.

Safety and efficacy of a new non-foreshortening nitinol stent in malignant gastric outlet obstruction (DUONITI study): A prospective, multicenter study (Article)

2011-06-08T00:00:00Z

Background and study aims: Gastric outlet obstruction (GOO) is a late complication of advanced gastric, periampullary, and duodenal malignancies. Palliation of obstruction is the primary aim of treatment in these patients. Self-expandable metal stents have emerged as a promising treatment option. Our aim was to investigate the safety and efficacy of a new non-foreshortening nitinol duodenal stent. Patients and methods: A total of 52 patients with symptomatic malignant GOO were studied in this prospective multicenter cohort study. All patients received a D-Weave Niti-S duodenal stent (Taewoong Medical, Seoul, South Korea). Patients were followed up until withdrawal of informed consent or death. Results: The cause of GOO was pancreatic cancer in the majority of patients (62%). The technical and clinical success rates were 96% and 77%, respectively. The GOO Scoring System score improved significantly (P<0.0001) when the scores before stenting were compared with the mean scores until death. Median survival was 82 days and stent patency was observed in 75% for up to 190 days, accounting for death as a competing risk. In 13 patients (25%) stent dysfunction occurred (tumor ingrowth in 11, stent migration in two). Over time, the body mass index, the World Health Organization performance score, and the EuroQol visual analog scale revealed a not significant change (P=0.52, P=0.43, and P=0.15, respectively), whereas the global health status improved significantly (P=0.001). Conclusion: Placement of a new non-foreshortening nitinol enteral stent is safe and without major complications. This stent design produces significant relief of obstructive symptoms and improves quality of life in patients with incurable malignant GOO.

Feasibility and yield of a new EUS histology needle: Results from a multicenter, pooled, cohort study (Article)

2011-06-01T00:00:00Z

Background: EUS-guided FNA is an efficacious technique for sampling intraintestinal and extraintestinal mass lesions. However, cytology has limitations to its final yield and accuracy, which may be overcome if histological specimens are provided to the pathologist. Objective: To evaluate feasibility, yield, and diagnostic accuracy of a newly developed 19-gauge, fine-needle biopsy (FNB) device. Design: Multicenter, pooled, cohort study. Setting: Five medical centers. Patients: This study involved 109 consecutive patients with 114 intraintestinal or extraintestinal mass lesions and/or peri-intestinal lymph nodes. Intervention: EUS-guided FNB (EUS-FNB) with a newly developed, 19-gauge, FNB device. Main Outcome Measurements: Percentage of cases in which pathologists classified the sample quality as optimal for histological evaluation and the overall diagnostic accuracy compared with a composite criterion-standard diagnosis. Results: We evaluated 114 lesions (mean [± standard deviation] size 35.1 ± 18.7 mm; 84 malignant [73.7%] and 30 [26.3%] benign). EUS-FNB was technically feasible in 112 lesions (98.24%). Sample quality was adequate for full histological assessment in 102 lesions (89.47%). In 98 cases (85.96%), diagnosis proved to be correct according to criterion-standard diagnosis. Sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy for diagnosis of malignancy were 90.2%, 100%, 100%, 78.9%, and 92.9%, respectively. Limitations: Use of a surrogate criterion-standard diagnosis, including clinical follow-up when no surgical specimens were available, mainly in benign diagnoses. Conclusion: Performing an EUS-FNB with a new 19-gauge histology needle is feasible for histopathology diagnosis of intraintestinal and extraintestinal mass lesions, offering the possibility of obtaining a core sample for histological evaluation in the majority of cases, with an overall diagnostic accuracy of over 85%.

Endoscopic ultrasound-guided fine-needle aspiration of pancreatic cystic lesions provides inadequate material for cytology and laboratory analysis: Initial results from a prospective study (Article)

2011-05-25T00:00:00Z

Background and study aims: Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is considered a valuable and safe technique for further investigation of pancreatic cystic lesions. In the framework of a prospective study on the accuracy of EUS-FNA we report our initial technical results regarding puncture access, sample adequacy, and complications Patients and methods: Consecutive patients with indeterminate pancreatic cystic lesions underwent EUS and EUS-FNA. Pancreatic cyst fluid was collected for cytopathological analysis and measurement of amylase, carcinoembryonic antigen (CEA), and carbohydrate antigen 19.9 (CA 19.9) levels. Main outcome parameter for this analysis was the percentage of samples adequate for cytologic and laboratory analysis. Results: Of 143 patients (median age 63 years; median cyst size 2.8cm) who underwent EUS, FNA was performed in 128 (90%). The various reasons for not doing FNA included large distance between transducer and cystic lesion (n=9), cyst not seen or too small (n=2), and evident diagnosis not requiring FNA (n=3). FNA was not possible in four patients (technical failures). Cyst fluid sent for cytology provided adequate cellular material in 44 cases only, accounting for an intention-to-diagnose yield of 31% (44/143). Sufficient fluid for biochemical analysis was obtained in 68 cases (49%). Complications occurred in three patients (2.4%). Conclusions: Although EUS-guided FNA was technically feasible in the majority of patients with pancreatic cystic lesions (87%), it was possible to obtain a classifying cytopathologic diagnosis and a chemical analysis in only a third and a half of cases, respectively.

Over papyrusrollen, krabben en de Top 10: voorkomen, genezen en pallieren (Inaugural Lecture)

2011-01-07T00:00:00Z

Rede, In verkorte vorm uitgesproken ter gelegenheid van het aanvaarden van het ambt van bijzonder hoogleraar met als leeropdracht Gastrointestinale Oncologie aan het Erasmus MC, faculteit van de Erasmus Universiteit Rotterdam op 7 januari 2011

Enteral nutrition and acute pancreatitis: A review (Article)

2011-01-01T00:00:00Z

Introduction. In patients with acute pancreatitis (AP), nutritional support is required if normal food cannot be tolerated within several days. Enteral nutrition is preferred over parenteral nutrition. We reviewed the literature about enteral nutrition in AP. Methods. A MEDLINE search of the English language literature between 1999-2009. Results. Nasogastric tube feeding appears to be safe and well tolerated in the majority of patients with severe AP, rendering the concept of pancreatic rest less probable. Enteral nutrition has a beneficial influence on the outcome of AP and should probably be initiated as early as possible (within 48 hours). Supplementation of enteral formulas with glutamine or prebiotics and probiotics cannot routinely be recommended. Conclusions. Nutrition therapy in patients with AP emerged from supportive adjunctive therapy to a proactive primary intervention. Large multicentre studies are needed to confirm the safety and effectiveness of nasogastric feeding and to investigate the role of early nutrition support.

Is early diagnosis of pancreatic cancer fiction? surveillance of individuals at high risk for pancreatic cancer (Article)

2010-11-01T00:00:00Z

Pancreatic cancer represents one of the most deadly human malignancies with an overall 5-year survival of less than 5%. Despite improvements in imaging techniques and surgical techniques, survival statistics have hardly improved over the past decades. To improve the dismal outlook it would be highly desirable to develop a program to detect precursor lesions or small asymptomatic early cancers at the time when the disease is still at a curable stage. Screening the general population for disease presence is not feasible at present because of the relatively low disease incidence and the lack of a noninvasive, reliable and cheap screening tool. Targeted surveillance programs, however, in individuals at high risk for developing pancreatic cancer, like mutation carriers of pancreatic cancer prone hereditary (tumor) syndromes or individuals with a strong family history of pancreatic cancer without a known underlying genetic defect, might be feasible. Careful consideration of the criteria put forward by Wilson and Jungner as published by the World Health Organization on the principles and practice of screening for disease, indicate that surveillance in this high-risk population by means of endosonography (EUS) and/or magnetic resonance imaging (MRI) represents a promising development, though experimental. It nicely points out which open questions need to be addressed. Among others, these include how to acquire a better understanding of the natural behavior and progression of precursor lesions towards invasive cancer, how to firmly establish the performance characteristics of EUS and MRI for the detection of (early) lesions in individuals at high risk for pancreatic cancer, and how to determine which lesions can be safely observed with continued surveillance and which lesions justify resection. © 2010 S. Karger AG, Basel.

Therapeutic delay and survival after surgery for cancer of the pancreatic head with or without preoperative biliary drainage (Article)

2010-11-01T00:00:00Z

Objective: To evaluate the relation between delay in surgery because of preoperative biliary drainage (PBD) and survival in patients scheduled for surgery for pancreatic head cancer. Background: Patients with obstructive jaundice due to pancreatic head cancer can undergo PBD. The associated delay of surgery can lead to more advanced cancer stages at surgical exploration, affecting resection rate and survival. Methods: We conducted a multicenter, randomized controlled clinical trial to compare PBD with early surgery (ES) for pancreatic head cancer for complications. We obtained Kaplan-Meier estimates of overall survival for patients with pathology-proven malignancy and compared survival functions of ES and PBD groups using log-rank test statistics. Multivariable Cox regression analyses were performed to evaluate the prognostic role of time to surgery for overall survival. Results: Mean times from randomization to surgery were 1.2 (0.9-1.5) and 5.1 (4.8-5.5) weeks in the ES and PBD groups, respectively (P < 0.001). In the ES group, 60 (67%) of 89 patients underwent resection, versus 53 (58%) of 91 patients in the PBD group (P = 0.20). Median survival after randomization was 12.2 (9.1-15.4) months in the ES group versus 12.7 (8.9-16.6) months in the PBD group (P = 0.91). A longer time to surgery was significantly associated with slightly lower mortality rate after surgery (hazard ratio = 0.90, 95% CI, 0.83-0.97), when taking into account resection, bilirubin, complications, pancreatic adenocarcinoma, tumor-positive lymph nodes, and microscopically residual disease. Conclusions: In patients with pancreatic head cancer, the delay in surgery associated with PBD does not impair or benefit survival rate. Copyright

Endoscopic treatment of acute biliary pancreatitis: A national survey among Dutch gastroenterologists (Article)

2010-09-01T00:00:00Z

Objective. Based on the ampullary obstruction and reflux theory, six endoscopic retrograde cholangiopancreatography (ERCP) studies have investigated the effect of (early) biliary decompression versus conservative management on the course and outcome of patients with acute biliary pancreatitis (ABP) showing inconsistent and contradictory outcomes. We investigated the opinion and attitude of Dutch gastroenterologists regarding the application of (early) ERCP in the clinical management of ABP by means of a nationwide survey. Material and methods. An anonymous questionnaire was sent to all registered consultant gastroenterologists (n 283) across the Netherlands. Results. The response rate was 52%. The vast majority of consulting gastroenterologists declared that early ERCP may be indicated in ABP (96.6%). Fourteen percent stated that they always perform ERCP in ABP. The remainder of the respondents consider ERCP only if a concomitant condition is present such as a dilated CBD (95%), co-existent cholangitis (87%), common bile duct stone(s) (CBDS) (72%), jaundice (59%), ampullary stone (68%) or (predicted) severe ABP (35%). About half of the consultant gastroenterologists (51.4%) consider the optimal time point for ERCP in ABP to be within 24 h after admission or symptom onset. If ERCP is performed for suspected APB, 55% of the respondents perform an endoscopic sphincterotomy (ES), regardless of the findings on cholangiography. Conclusions. The vast majority of Dutch gastroenterologists attest to a role for ERCP in ABP, but indications when to perform ERCP, its timing, and the application of ES vary greatly and are not always in line with the Dutch or other published national guidelines. The results of this survey highlight the need for additional comparative randomized studies to define the role of (early) ERCP in ABP.

Etiology and diagnosis of acute biliary pancreatitis (Article)

2010-09-01T00:00:00Z

Establishing a biliary etiology in acute pancreatitis is clinically important because of the potential need for invasive treatment, such as endoscopic retrograde cholangiopancreatography. The etiology of acute biliary pancreatitis (ABP) is multifactorial and complex. Passage of small gallbladder stones or biliary sludge through the ampulla of Vater seems to be important in the pathogenesis of ABP. Other factors, such as anatomical variations associated with an increased biliopancreatic reflux, bile and pancreatic juice exclusion from the duodenum, and genetic factors might contribute to the development of ABP. A diagnosis of a biliary etiology in acute pancreatitis is supported by both laboratory and imaging investigations. An increased serum level of alanine aminotransferase (>1.0 μkat/l) is associated with a high probability of gallstone pancreatitis (positive predictive value 80-90%). Confirmation of choledocholithiasis is most accurately obtained using endoscopic ultrasonography or magnetic resonance cholangiopancreatography. This Review discusses the pathogenesis of ABP and the clinical techniques used to predict and establish a biliary origin in patients with suspected ABP.

Esophageal stents for the palliation of malignant dysphagia and fistula recurrence after esophagectomy (Article)

2010-08-01T00:00:00Z

Background: Despite advances in staging methods, surgical techniques, and adjuvant treatment, recurrent cancer after esophagectomy is a major cause of morbidity and mortality. Objective: Our purpose was to investigate the safety and efficacy of a self-expandable metal stent (SEMS) in patients with dysphagia or fistula caused by recurrent cancer after esophagectomy. Design: Prospective, observational study with standardized treatment and follow-up. Setting: Single university center. Patients: In 81 patients with recurrent cancer after previous surgical esophagectomy, 100 esophageal SEMSs were inserted for dysphagia (n = 66) or fistula formation (n = 15). Interventions: Stent placement. Main Outcome Measurements: Technical and functional outcome, complications, and survival. Results: The SEMSs restored luminal patency in 65 (98%) of 66 patients and sealed malignant fistulae in 14 (93%) of 15 patients. Stent dysfunction occurred in 24 (30%) of 81 patients. They all were successfully managed by subsequent endoscopic intervention. After stent placement, a total of 16 complications were observed. Major complications occurred in 9 (11%) of 81 patients, mild complications occurred in 7 (9%) of 81 patients. The overall 30-day mortality rate after stent insertion was 25%. Progression of the disease resulted in death after a median interval of 70 days (range 1 day to 91 months). Limitations: Nonrandomized design. Conclusions: SEMS placement in recurrent esophageal cancer after surgical resection offers adequate palliation by relieving dysphagia and sealing off esophageal respiratory fistulae. Therefore, in these patients who have a relatively short life expectancy, SEMS placement should be considered the treatment of choice.

Esophageal stents for the relief of malignant dysphagia due to extrinsic compression (Article)

2010-07-09T00:00:00Z

Background and study aims: In patients with primary esophageal cancer, luminal patency can be restored by placement of a self-expandable metal stent (SEMS). The use of SEMS in patients with dysphagia caused by malignant extrinsic compression has largely been unreported. In this study we evaluated the efficacy of SEMS in a large cohort of patients with malignant extrinsic compression. Patients and methods: This was a prospective single-center study. Between 1995 and 2009, 50 consecutive patients with malignant extrinsic compression who had undergone SEMS placement were included (mean age 64 years; 37-males). In the majority of patients, extrinsic esophageal compression was caused by obstructive pulmonary cancer (n=23) and by mediastinal metastasis after esophagectomy for esophageal cancer (n=16). Results: Stent placement was technically successful in all patients. Severe complications occurred in 5/50 patients (10%) including perforation during dilation prior to stent insertion (n=2) and hemorrhage (n=3). Two patients (4%) died from bleeding. Mild complications were seen in 9/50 patients (18%). Recurrent dysphagia occurred in eight patients (16%) and was successfully managed by subsequent endoscopic intervention. Median survival after stent placement was 44 days (range 5 days2 years). The median stent patency of 46 days in this series exceeded median patient survival. Conclusions: Insertion of an SEMS is an effective palliative treatment for patients with dysphagia due to malignant extrinsic compression. In spite of the short survival, some patients present with recurrent dysphagia, which can be managed effectively by endoscopic re-intervention.

Surveillance in individuals at high risk of pancreatic cancer: Too early to tell? (Article)

2010-07-01T00:00:00Z

Short-term esophageal stenting in the management of benign perforations (Article)

2010-07-01T00:00:00Z

OBJECTIVES: The standard approach to benign esophageal perforations consists of conservative treatment or surgery. In this study, we investigated the efficacy of short-term stent placement for nonmalignant esophageal perforations. METHODS: This is a prospective single-center study of patients with benign esophageal perforations in whom a removable self-expandable stent was placed. Data were collected from a prospective database, endoscopy records, and operation reports. To obtain follow-up data, we contacted the patients, their relatives, or their general practitioner. Results: A total of 33 patients underwent stent insertion owing to an iatrogenic perforation (n=19), Boerhaave's syndrome (n=10), or other causes (n=4); this resulted in an immediate and complete sealing of the lesion in 32 patients (97%). Stents migrated in 11 patients (33%). Four patients required an esophageal resection for failed stent therapy (n3) and failed stent removal (n1). The 90-day mortality rate was 15%. A total of 33 endoscopic stent extractions were attempted. Overall, 23 stents were extracted within 6 weeks (group I) and 10 stents between 6 and 84 weeks (group II). Extractions were uncomplicated in all patients in group I (100%) vs. in 5 patients in group II (50%) (P0.001). Six extraction-related complications occurred in group II, including two self-limiting bleedings, three stent fractures, and one impacted stent. Conclusions: In patients with a benign esophageal perforation, temporary stent therapy is effective and provides a good alternative to surgery. Complications due to stent removal can be prevented by removal of the prosthesis within 6 weeks after insertion, without compromising the efficacy of treatment.

Pancreatic enzyme replacement therapy in chronic pancreatitis (Article)

2010-06-01T00:00:00Z

Exocrine pancreatic insufficiency (EPI) is a serious condition which occurs in several diseases including chronic pancreatitis (CP), cystic fibrosis, pancreatic cancer, and as a result of pancreatic surgery. The lack or absence of pancreatic enzymes leads to an inadequate absorption of fat, proteins, and carbohydrates, causing steatorrhoea and creathorrhea which results in abdominal discomfort, weight loss, and nutritional deficiencies. To avoid malnutrition related morbidity and mortality, it is pivotal to commence pancreatic enzyme replacement therapy (PERT) as soon as EPI is diagnosed. Factors as early acidic inactivation of ingested enzymes, under dosage, and patient incompliance may prevent normalisation of nutrient absorption, in particular of fat digestion. This review focuses on the current status of how to diagnose and treat EPI.

The staging of gastritis with the OLGA system by using intestinal metaplasia as an accurate alternative for atrophic gastritis (Article)

2010-06-01T00:00:00Z

Background: The OLGA (operative link on gastritis assessment) staging system is based on severity of atrophic gastritis (AG). AG remains a difficult histopathologic diagnosis with low interobserver agreement, whereas intestinal metaplasia (IM) is associated with high interobserver agreement. Objective: The aim of this study was to evaluate whether a staging system based on IM is preferable to estimate gastric cancer risk. Design and Setting: Prospective multicenter study. Patients: A total of 125 patients previously diagnosed with gastric IM or dysplasia. Interventions: Surveillance endoscopy with extensive biopsy sampling. Main Outcome Measurements: Three pathologists graded biopsy specimens according to the Sydney classification. Interobserver agreement was analyzed by kappa statistics. In the OLGA, AG was replaced by IM, creating the OLGIM. Results: Interobserver agreement was fair for dysplasia (κ = 0.4), substantial for AG (κ = 0.6), almost perfect for IM (κ = 0.9), and improved for all stages of OLGIM compared with OLGA. Overall, 84 (67%) and 79 (63%) patients were classified as stage I-IV according to OLGA and OLGIM, respectively. Of the dysplasia patients, 5 (71%) and 6 (86%) clustered in stage III-IV of OLGA and OLGIM, respectively. Limitation: Prospective studies should confirm the correlation between gastric cancer risk and OLGIM stages. Conclusion: Replacement of AG by IM in the staging of gastritis considerably increases interobserver agreement. The correlation with the severity of gastritis remains at least as strong. Therefore, the OLGIM may be preferred over the OLGA for the prediction of gastric cancer risk in patients with premalignant lesions.

Azathioprine or mercaptopurine-induced acute pancreatitis is not a disease-specific phenomenon (Article)

2010-06-01T00:00:00Z

Several reports suggest an increased rate of adverse reactions to azathioprine in patients with Crohn's disease. Aim To compare the incidence of thiopurine-induced acute pancreatitis in patients with inflammatory bowel disease (IBD) with that in patients with vasculitis. Methods This retrospective analysis was performed using data collected in three databases by two university hospitals (241 patients with IBD and 108 patients with vasculitis) and one general district hospital (72 patients with IBD). Results The cumulative incidence of thiopurine-induced acute pancreatitis in Crohn's disease equalled that of ulcerative colitis (UC) (2.6% vs. 3.7%) and this did not differ from vasculitis patients (2.6% vs.1.9%). In addition, the cumulative incidence of thiopurine-induced acute pancreatitis in UC patients was not different from that in vasculitis patients. In the IBD group, 100% of thiopurine-induced acute pancreatitis patients were women, whereas in the vasculitis group the two observed thiopurine-induced acute pancreatitis cases (n = 2 of 2) concerned were men (P = 0.012). Conclusions In this study, the alleged higher cumulative incidence of thiopurine-induced acute pancreatitis in Crohn's disease compared with vasculitis or UC patients was not confirmed. Female gender appears to be a risk factor for developing thiopurine-induced acute pancreatitis in IBD patients.

Best Practice and Research: Clinical Gastroenterology: Preface (Article)

2010-06-01T00:00:00Z

Functional changes after pancreatoduodenectomy: Diagnosis and treatment (Article)

2010-04-01T00:00:00Z

Relatively little is known about the gastrointestinal function after recovery of a pancreatoduodenectomy. This review focuses on the functional changes of the stomach, duodenum and pancreas that occur after pancreatoduodenectomy. Although the mortality in relation to pancreatoduodenectomy has decreased over the years, it remains associated with considerable morbidity, which occurs in 40-60% of patients. Physical complaints early after the operation are often caused by motility disorders, in particular delayed gastric emptying, which occurs in up to 40% of patients. During longer follow-up of these patients the occurrence of endocrine and exocrine pancreatic insufficiency becomes more predominant. Diabetes mellitus develops in 20-50% of patients after a pancreatic resection (pancreatogenic diabetes). The main presenting symptoms of exocrine insufficiency are weight loss and steatorrhea. Its presence is suspected on clinical ground and can be supported by fecal elastase-1 measurement. Exocrine insufficiency can be compensated with oral enteric-coated enzyme supplements. The quality of life issue will be addressed as an important outcome measurement after pancreaticoduodenectomy. Furthermore, the functional changes after pancreatoduodenectomy are described in detail with suggestions for diagnosis and treatment.

Risk and Epidemiological Time Trends of Gastric Cancer in Lynch Syndrome Carriers in The Netherlands (Article)

2010-02-01T00:00:00Z

Background & Aims: Although gastric cancer forms part of the Lynch syndrome tumor spectrum, the risk of developing gastric cancer in Lynch syndrome families is unknown, resulting in a lack of clear guidelines for surveillance. The aim of this study was to evaluate incidence trends and risk of developing gastric cancer among Lynch syndrome mutation carriers in a Western population. Methods: Lynch syndrome mutation carriers were selected from the Dutch Hereditary Cancer Registry. The gastric cancer incidence in Lynch syndrome mutation carriers was compared to the gastric cancer incidence in the Dutch population between 1970 and 2003. Standardized incidence ratios were calculated by a Poisson model. Cumulative risks were calculated by Kaplan-Meier analysis. Results: Overall, 2014 Lynch syndrome mutation carriers were identified. Gastric cancer was diagnosed in 32 (1.6%) subjects (male/female: 21/11), 22 (69%) of them had a negative family history of gastric cancer. The standardized incidence ratios of gastric cancer was 3.4 (95% confidence interval, 2.1-5.2) and showed a nonsignificant decline between 1970 and 2003 (P = .30). Absolute risk of developing gastric cancer also showed no significant change over time (P = .51). Lifetime risk of developing gastric cancer was 8.0% in males vs 5.3% in females (P = .02), and 4.8% and 9% for MLH1 and MSH2 carriers, respectively. None of the 378 MSH6 carriers developed gastric cancer (P = .002 vs MLH1 and MSH2 combined lifetime risk). Conclusions: Lynch syndrome mutation carriers have a substantial risk for gastric cancer, in particular patients with an MLH1 or MSH2 mutation. Family history for gastric cancer is a poor indicator for individual risk. Surveillance gastroscopy for Lynch syndrome patients carrying an MLH1 or MSH2 mutation should therefore be considered.

Preoperative biliary drainage for cancer of the head of the pancreas (Article)

2010-01-14T00:00:00Z

BACKGROUND: The benefits of preoperative biliary drainage, which was introduced to improve the postoperative outcome in patients with obstructive jaundice caused by a tumor of the pancreatic head, are unclear. METHODS: In this multicenter, randomized trial, we compared preoperative biliary drainage with surgery alone for patients with cancer of the pancreatic head. Patients with obstructive jaundice and a bilirubin level of 40 to 250 μmol per liter (2.3 to 14.6 mg per deciliter) were randomly assigned to undergo either preoperative biliary drainage for 4 to 6 weeks, followed by surgery, or surgery alone within 1 week after diagnosis. Preoperative biliary drainage was attempted primarily with the placement of an endoprosthesis by means of endoscopic retrograde cholangiopancreatography. The primary outcome was the rate of serious complications within 120 days after randomization. RESULTS: We enrolled 202 patients; 96 were assigned to undergo early surgery and 106 to undergo preoperative biliary drainage; 6 patients were excluded from the analysis. The rates of serious complications were 39% (37 patients) in the early-surgery group and 74% (75 patients) in the biliary-drainage group (relative risk in the early-surgery group, 0.54; 95% confidence interval [CI], 0.41 to 0.71; P<0.001). Preoperative biliary drainage was successful in 96 patients (94%) after one or more attempts, with complications in 47 patients (46%). Surgery-related complications occurred in 35 patients (37%) in the early-surgery group and in 48 patients (47%) in the biliary-drainage group (relative risk, 0.79; 95% CI, 0.57 to 1.11; P = 0.14). Mortality and the length of hospital stay did not differ significantly between the two groups. CONCLUSIONS: Routine preoperative biliary drainage in patients undergoing surgery for cancer of the pancreatic head increases the rate of complications. (Current Controlled Trials number, ISRCTN31939699.) Copyright

Editorial: Diagnosing and staging bile duct cancer: Cholangiographically guided biopsies or cholangioscopy? (Article)

2009-11-01T00:00:00Z

Endosonography in the management of biliopancreatic disorders (Article)

2009-10-01T00:00:00Z

Over the past two decades, endoscopic endosonography (EUS) has evolved into an indispensible diagnostic and therapeutic utility in the diagnosis and treatment of patients with pancreatobiliary disease. In this article, we summarise its current potential and provide an update of the latest literature.

The yield of first-time endoscopic ultrasonography in screening individuals at a high risk of developing pancreatic cancer (Article)

2009-09-01T00:00:00Z

OBJECTIVES:Approximately 10-15% of all pancreatic cancers (PCs) may be hereditary in origin. We investigated the use of endoscopic ultrasonography (EUS) for the screening of individuals at high risk for developing PC. In this paper the results of first-time screening with EUS are presented.METHODS:Those eligible for screening in this study were first-degree family members of affected individuals from familial pancreatic cancer (FPC) families, mutation carriers of PC-prone hereditary syndromes, individuals with Peutz-Jeghers syndrome, and mutation carriers of other PC-prone hereditary syndromes with clustering (2 cases per family) of PC. All individuals were asymptomatic and had not undergone EUS before.RESULTS:Forty-four individuals (M/F 18/26), aged 32-75 years underwent screening with EUS. Thirteen were from families with familial atypical multiple-mole melanoma (FAMMM), 21 with FPC, 3 individuals were diagnosed with hereditary pancreatitis, 2 were Peutz-Jeghers patients, 3 were BRCA1 and 2 were BRCA2 mutation carriers with familial clustering of PC, and 1 individual had a p53 mutation. Three (6.8%) patients had an asymptomatic mass lesion (12, 27, and 50 mm) in the body (n2) or tail of the pancreas. All lesions were completely resected. Pathology showed moderately differentiated adenocarcinomas with N1 disease in the two patients with the largest lesions. EUS showed branch-type intraductal papillary mucinous neoplasia (IPMN) in seven individuals.CONCLUSIONS:Screening of individuals at a high risk for PC with EUS is feasible and safe. The incidence of clinically relevant findings at first screening is high with asymptomatic cancer in 7% and premalignant IPMN-like lesions in 16% in our series. Whether screening improves survival remains to be determined, as does the optimal screening interval with EUS.

Early endoscopic retrograde cholangiopancreatography in predicted severe acute biliary pancreatitis: A prospective multicenter study (Article)

2009-07-01T00:00:00Z

SUMMARY BACKGROUND DATA: The role of early endoscopic retrograde cholangiopancreatography (ERCP) in acute biliary pancreatitis (ABP) remains controversial. Previous studies have included only a relatively small number of patients with predicted severe ABP. We investigated the clinical effects of early ERCP in these patients. METHODS: We performed a prospective, observational multicenter study in 8 university medical centers and 7 major teaching hospitals. One hundred fifty-three patients with predicted severe ABP without cholangitis enrolled in a randomized multicenter trial on probiotic prophylaxis in acute pancreatitis were prospectively followed. Conservative treatment or ERCP within 72 hours after symptom onset (at discretion of the treating physician) were compared for complications and mortality. Patients without and with cholestasis (bilirubin: >2.3 mg/dL [40 μmol/L] and/or dilated common bile duct) were analyzed separately. RESULTS: Of the 153 patients, 81 (53%) underwent ERCP and 72 (47%) conservative treatment. Groups were highly comparable at baseline. Seventy-eight patients (51%) had cholestasis. In patients with cholestasis, ERCP (52/78 patients: 67%), as compared with conservative treatment, was associated with fewer complications (25% vs. 54%, P = 0.020, multivariate adjusted odds ratio [OR]: 0.35, 95% confidence interval [CI]: 0.13-0.99, P= 0.049). This included fewer patients with >30% pancreatic necrosis (8% vs. 31%, P = 0.010). Mortality was nonsignificantly lower after ERCP (6% vs. 15%, P = 0.213, multivariate adjusted OR: 0.44, 95% CI: 0.08-2.28, P = 0.330). In patients without cholestasis, ERCP (29/75 patients: 39%) was not associated with reduced complications (45% vs. 41%, P = 0.814, multivariate adjusted OR: 1.36; 95% CI: 0.49-3.76; P = 0.554) or mortality (14% vs. 17%, P = 0.754, multivariate adjusted OR: 0.78; 95% CI: 0.19-3.12, P = 0.734). CONCLUSIONS: Early ERCP is associated with fewer complications in predicted severe ABP if cholestasis is present.

Recurrent acute biliary pancreatitis: The protective role of cholecystectomy and endoscopic sphincterotomy (Article)

2009-05-01T00:00:00Z

Background: Recurrent attacks of acute biliary pancreatitis (RABP) are prevented by (laparoscopic) cholecystectomy. Since the introduction of endoscopic retrograde cholangiopancreaticography (ERCP), several series have described a similar reduction of RABP after endoscopic sphincterotomy (ES). This report discusses the different treatment options for preventing RABP including conservative treatment, cholecystectomy, ES, and combinations of these options as well as their respective timing. Methods: A search in PubMed for observational studies and clinical (comparative) trials published in the English language was performed on the subject of recurrent acute biliary pancreatitis and other gallstone complications after an initial attack of acute pancreatitis. Result: Cholecystectomy and ES both are superior to conservative treatment in reducing the incidence of RABP. Cholecystectomy provides additional protection for gallstone-related complications and mortality. Observational studies indicate that cholecystectomy combined with ES is the most effective treatment for reducing the incidence of RABP attacks. Conclusion: From the literature data it can be concluded that ES is as effective in reducing RABP as cholecystectomy but inferior in reducing mortality and overall morbidity. The combination of ES and cholecystectomy seems superior to either of the treatment methods alone. A prospective randomized clinical trial comparing ES plus cholecystectomy with cholecystectomy alone is needed.

Spontaneous drainage of a pancreatic pseudocyst after embolization of a bleeding pseudoaneurysm (Article)

2009-01-01T00:00:00Z

Efficacy and safety of the new WallFlex enteral stent in palliative treatment of malignant gastric outlet obstruction (DUOFLEX study): a prospective multicenter study (Article)

2008-01-01T00:00:00Z

Background: Gastric outlet obstruction (GOO) is most commonly a complication of advanced distal gastric, periampullary, or duodenal malignancy. Palliation of obstruction is the primary aim of treatment in most of these patients. Self-expandable metal stents have emerged as an effective treatment option. Objective: Our purpose was to investigate the efficacy and safety of a newly developed enteral metal stent (WallFlex). Design: Prospective multicenter cohort study. Setting: Three tertiary referral centers (2 academic). Patients: Fifty-one consecutive patients with symptomatic malignant GOO from January 2005 to February 2006. Intervention: Placement of a self-expandable metallic stent (WallFlex). Main Outcome Measurements: The primary end point was defined as improvement of the GOO scoring system for the remainder of the patients' lives. Secondary end points focused on efficacy and safety and global quality of life. Results: The Gastric Outlet Obstruction Scoring System score improved (P < .001), the body mass index decreased (P < .001), and the World Health Organization performance score improved (P = .002) when the score before stenting was compared with the mean score until death. Global quality of life did not improve. Technical and clinical success was achieved in 98% and 84% of the patients. Median survival was 62 days (75% alive at 35 days, 25% alive at 156 days). Median stent patency was 307 days (75% functional at 135 days, 25% functional at 470 days). Stent dysfunction was proved in 7 patients (14%), migration in 1 (2%), and tumor overgrowth or ingrowth in 6 (12%). Limitations: Lack of a control group. Conclusion: Placement of a WallFlex enteral stent in patients with nonresectable malignant GOO is safe and provides a statistically significant and clinically relevant relief of obstructive symptoms with a low need for reintervention.

Preoperative biliary drainage for periampullary tumors causing obstructive jaundice; DRainage vs. (direct) OPeration (DROP-trial) (Article)

2007-03-22T00:00:00Z

Background. Surgery in patients with obstructive jaundice caused by a periampullary (pancreas, papilla, distal bile duct) tumor is associated with a higher risk of postoperative complications than in non-jaundiced patients. Preoperative biliary drainage was introduced in an attempt to improve the general condition and thus reduce postoperative morbidity and mortality. Early studies showed a reduction in morbidity. However, more recently the focus has shifted towards the negative effects of drainage, such as an increase of infectious complications. Whether biliary drainage should always be performed in jaundiced patients remains controversial. The randomized controlled multicenter DROP-trial (DRainage vs. Operation) was conceived to compare the outcome of a 'preoperative biliary drainage strategy' (standard strategy) with that of an 'early-surgery' strategy, with respect to the incidence of severe complications (primary-outcome measure), hospital stay, number of invasive diagnostic tests, costs, and quality of life. Methods/design. Patients with obstructive jaundice due to a periampullary tumor, eligible for exploration after staging with CT scan, and scheduled to undergo a "curative" resection, will be randomized to either "early surgical treatment" (within one week) or "preoperative biliary drainage" (for 4 weeks) and subsequent surgical treatment (standard treatment). Primary outcome measure is the percentage of severe complications up to 90 days after surgery. The sample size calculation is based on the equivalence design for the primary outcome measure. If equivalence is found, the comparison of the secondary outcomes will be essential in selecting the preferred strategy. Based on a 40% complication rate for early surgical treatment and 48% for preoperative drainage, equivalence is taken to be demonstrated if the percentage of severe complications with early surgical treatment is not more than 10% higher compared to standard treatment: preoperative biliary drainage. Accounting for a 10% dropout, 105 patients are needed in each arm resulting in a study population of 210 (alpha = 0.95, beta = 0.8). Discussion. The DROP-trial is a randomized controlled multicenter trial that will provide evidence whether or not preoperative biliary drainage is to be performed in patients with obstructive jaundice due to a periampullary tumor.