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

doi:10.1016/j.gie.2008.07.026

Gastrointestinal Endoscopy

Volume 69, Issue 6, May 2009, Pages 1059-1066

https://doi.org/10.1016/j.gie.2008.07.026 Get rights and content

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.

Section snippets

Methods

The DUOFLEX study was designed as a multicenter, single-arm, prospective, observational clinical trial to evaluate the efficacy and safety of the WallFlex enteral stent in 3 large Dutch hospitals. The protocol was approved by the Medical Ethical Committee of the Academic Medical Center in Amsterdam. The study was conducted at the Department of Gastroenterology and Hepatology of the Academic Medical Center in Amsterdam, Erasmus Medical Center in Rotterdam, and St Antonius Hospital in Nieuwegein.

Results

Between January 2005 and February 2006, 51 patients (25 men, 26 women; mean age ± SD 67.6 ± 12.3 years) were included. Fourteen of the 51 patients had already been included in a previous multicenter European study reporting only short-term (30-day) results.²⁷ Patient demographics and clinical characteristics are summarized in Table 1.

Discussion

Several studies have assessed clinical and technical success of endoscopic duodenal stenting in the palliative treatment of advanced periampullary, distal stomach, or duodenal cancer. Our prospective series is the first to focus on the duodenal WallFlex stent. The clinical and technical success rate (intention-to-treat) with this new enteral stent in the management of malignant duodenal strictures was 84% and 98%, respectively, which is in accordance with the recent literature.24, 25 A more

Conclusion

This single-arm prospective cohort study showed that placement of a WallFlex enteral stent in patients with nonresectable malignant GOO is safe and provides a statistically and clinically significant relief of obstructive symptoms until death.

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The was an international, multicentre, randomised, controlled trial conducted at seven sites in Hong Kong, Belgium, Brazil, India, Italy, and Spain. Consecutive patients (aged ≥18 years) with malignant gastric outlet obstruction due to unresectable primary gastroduodenal or pancreatobiliary malignancies, a gastric outlet obstruction score (GOOS) of 0 (indicating an inability in intake food or liquids orally), and an Eastern Cooperative Oncology Group performance status score of 3 or lower were included and randomly allocated (1:1) to receive either EUS-GE or duodenal stenting. The primary outcome was the 6-month reintervention rate, defined as the percentage of patients requiring additional endoscopic intervention due to stent dysfunction (ie, restenosis of the stent due to tumour ingrowth, tumour overgrowth, or food residue; stent migration; or stent fracture) within 6 months, analysed in the intention-to-treat population. Prespecified secondary outcomes were technical success (successful placement of a stent), clinical success (1-point improvement in gastric outlet obstruction score [GOOS] within 3 days), adverse events within 30 days, death within 30 days, duration of stent patency, GOOS at 1 month, and quality-of-life scores. This study is registered with ClinicalTrials.gov (NCT03823690) and is completed.
Between Dec 1, 2020, and Feb 28, 2022, 185 patients were screened and 97 (46 men and 51 women) were recruited and randomly allocated (48 to the EUS-GE group and 49 to the duodenal stent group). Mean age was 69·5 years (SD 12·6) in the EUS-GE group and 64·8 years (13·0) in the duodenal stent group. All randomly allocated patients completed follow-up and were analysed. Reintervention within 6 months was required in two (4%) patients in the EUS-GE group and 14 (29%) in the duodenal stent group [p=0·0020; risk ratio 0·15 [95% CI 0·04–0·61]). Stent patency was longer in the EUS-GE group (median not reached in either group; HR 0·13 [95% CI 0·08–0·22], log-rank p<0·0001). 1-month GOOS was significantly better in the EUS-GE group (mean 2·41 [SD 0·7]) than the duodenal stent group (1·91 [0·9], p=0·012). There were no statistically significant differences between the EUS-GE and duodenal stent groups in death within 30 days (ten [21%] vs six [12%] patients, respectively, p=0·286), technical success, clinical success, or quality-of-life scores at 1 month. Adverse events occurred 11 (23%) patients in the EUS-GE group and 12 (24%) in the duodenal stent group within 30 days (p=1·00); three cases of pneumonia (two in the EUS-GE group and one in the duodenal stent group) were considered to be procedure related.
In patients with malignant gastric outlet obstruction, EUS-GE can reduce the frequency of reintervention, improve stent patency, and result in better patient-reported eating habits compared with duodenal stenting, and the procedure should be used preferentially over duodenal stenting when expertise and required devices are available.
Research Grants Council (Hong Kong Special Administrative Region, China) and Sociedad Española de Endoscopia Digestiva.
Prospective multicenter assessment of the impact of EUS-guided gastroenterostomy on patient quality of life in unresectable malignant gastric outlet obstruction
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EUS-guided gastroenterostomy (EUS-GE) is increasingly used for malignant gastric outlet obstruction (GOO) in inoperable patients. However, the impact of EUS-GE on patient quality of life (QoL) has not been evaluated prospectively.
Consecutive patients with unresectable malignant GOO who underwent EUS-GE between August 2019 and May 2021 at 4 Spanish centers were prospectively assessed using the European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 at baseline and 1 month after the procedure. Centralized follow-up by telephone calls was undertaken. The Gastric Outlet Obstruction Scoring System (GOOSS) was used to assess oral intake, defining clinical success as a GOOSS ≥2. Differences between baseline and 30-day QoL scores were assessed using a linear mixed model.
Sixty-four patients were enrolled, 33 (51.6%) men, with a median age of 77.3 years (interquartile range, 65.5-86.5). The most common diagnoses were pancreatic (35.9%) and gastric (31.3%) adenocarcinoma. Thirty-seven patients (57.9%) presented a 2/3 baseline Eastern Cooperative Oncology Group performance status score. Oral intake was restarted within 48 hours in 61 patients (95.3%), and the median postprocedure hospital stay was 3.5 days (interquartile range, 2-5). The 30-day clinical success rate was 83.3%. A clinically significant increase of 21.6 points (95% confidence interval, 11.5-31.7) in the global health status scale was documented, with significant improvements in nausea and vomiting, pain, constipation, and appetite loss.
EUS-GE relieves GOO symptoms in patients with unresectable malignancy, allowing rapid oral intake and hospital discharge. It also provides a clinically relevant increase in QoL scores at 30 days from baseline. (Clinical trial registration number: NCT04660695.)
Intervention for Gastric Outlet and Duodenal Obstruction
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Gastric outlet obstruction is a preterminal complication of advanced malignancies of the pancreas, stomach, and duodenum. Balloon dilation, as well as placement of metallic stents, has been applied successfully in patients who are not surgical candidates. This chapter reviews the indications, contraindications, equipment, technique, controversies, outcomes, complications, and postprocedural care of gastroduodenal intervention.
Partially covered versus uncovered pyloro-duodenal stents for unresectable malignant gastric outlet obstruction: Randomized controlled study
2024, Digestive Endoscopy
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WallFlex<sup>®</sup> and Evolution<sup>®</sup> Duodenal Stents Have Similar Efficacy but Different Safety for Malignant Gastric Outlet Obstruction
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: DISCLOSURE: The following authors disclosed financial relationships relevant to this publication: P. Fockens, M. J. Bruno: Consultants to Boston Scientific. All other authors disclosed no financial relationships relevant to this publication.

: If you want to chat with an author of this article, you may contact him at [email protected].

: See CME section; p. 1148.

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

Background

Objective

Design

Setting

Patients

Intervention

Main Outcome Measurements

Results

Limitations

Conclusion

Section snippets

Methods

Results

Discussion

Conclusion

Is prophylactic gastrojejunostomy indicated for unresectable periampullary cancer? A prospective randomized trial

Ann Surg

Palliative treatment in “peri”-pancreatic carcinoma: stenting or surgical therapy?

Acta Gastroenterol Belg

Adjuvant combination chemotherapy (AMF) following radical resection of carcinoma of the pancreas and papilla of Vater—results of a controlled, prospective, randomised multicentre study

Eur J Cancer

Prognostic indicators for survival after resection of pancreatic adenocarcinoma

Am J Surg

Survival after pancreatoduodenectomy: 118 consecutive resections without an operative mortality

Ann Surg

Pylorus-preserving pancreatoduodenectomy: is it an adequate cancer operation?

Arch Surg

Pancreatic carcinoma

N Engl J Med

Laparoscopic biliary and enteric bypass

Semin Surg Oncol

Palliation: surgical and otherwise

Cancer

Surgical palliation of unresectable periampullary adenocarcinoma in the 1990s

J Am Coll Surg

Endoscopy or surgery for malignant GI outlet obstruction?

Gastrointest Endosc

Palliation of malignant gastroduodenal obstruction with open surgical bypass or endoscopic stenting: clinical outcome and health economic evaluation

World J Surg

Prospective randomized trial of laparoscopic gastrojejunostomy versus duodenal stenting for malignant gastric outflow obstruction

Surg Endosc

Surgical palliation for pancreatic cancer: developments during the past two decades

Br J Surg

Delayed gastric emptying after palliative gastrojejunostomy for carcinoma of the pancreas

Arch Surg

Is there a place for gastroenterostomy in patients with advanced cancer of the head of the pancreas?

World J Surg

Gastric outlet obstruction secondary to pancreatic cancer: surgical vs endoscopic palliation

Surg Endosc

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