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
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.
References (35)
- et al.
Is prophylactic gastrojejunostomy indicated for unresectable periampullary cancer? A prospective randomized trial
Ann Surg
(1999) - et al.
Palliative treatment in “peri”-pancreatic carcinoma: stenting or surgical therapy?
Acta Gastroenterol Belg
(2002) - et al.
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
(1993) - et al.
Prognostic indicators for survival after resection of pancreatic adenocarcinoma
Am J Surg
(1993) - et al.
Survival after pancreatoduodenectomy: 118 consecutive resections without an operative mortality
Ann Surg
(1990) - et al.
Pylorus-preserving pancreatoduodenectomy: is it an adequate cancer operation?
Arch Surg
(1994) - et al.
Pancreatic carcinoma
N Engl J Med
(1992) - et al.
Laparoscopic biliary and enteric bypass
Semin Surg Oncol
(1999) - et al.
Palliation: surgical and otherwise
Cancer
(1996) - et al.
Surgical palliation of unresectable periampullary adenocarcinoma in the 1990s
J Am Coll Surg
(1999)
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
Cited by (167)
Intervention for Gastric Outlet and Duodenal Obstruction
2020, Image-Guided Interventions: Expert Radiology Series, Third EditionEfficacy and safety of self-expandable metal stent placement for treatment of primary and metastatic gastric outlet obstruction
2023, Irish Journal of Medical ScienceWallFlex<sup>®</sup> and Evolution<sup>®</sup> Duodenal Stents Have Similar Efficacy but Different Safety for Malignant Gastric Outlet Obstruction
2023, Digestive Diseases and Sciences
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.