Document Detail

Efficacy and safety of the new WallFlex enteral stent in palliative treatment of malignant gastric outlet obstruction (DUOFLEX study): a prospective multicenter study.
MedLine Citation:
PMID:  19152912     Owner:  NLM     Status:  MEDLINE    
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.
Jeanin E van Hooft; Madeleen J Uitdehaag; Marco J Bruno; Robin Timmer; Peter D Siersema; Marcel G W Dijkgraaf; Paul Fockens
Publication Detail:
Type:  Journal Article; Multicenter Study     Date:  2009-01-18
Journal Detail:
Title:  Gastrointestinal endoscopy     Volume:  69     ISSN:  1097-6779     ISO Abbreviation:  Gastrointest. Endosc.     Publication Date:  2009 May 
Date Detail:
Created Date:  2009-05-04     Completed Date:  2009-08-06     Revised Date:  2010-09-03    
Medline Journal Info:
Nlm Unique ID:  0010505     Medline TA:  Gastrointest Endosc     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1059-66     Citation Subset:  IM    
Academic Medical Center, Amsterdam, Netherlands.
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MeSH Terms
Activities of Daily Living / classification
Aged, 80 and over
Ampulla of Vater*
Body Mass Index
Cholangiocarcinoma / mortality,  therapy*
Cohort Studies
Common Bile Duct Neoplasms / mortality,  therapy*
Duodenal Neoplasms / mortality,  therapy*
Equipment Failure Analysis
Equipment Safety
Follow-Up Studies
Gastric Outlet Obstruction / mortality,  therapy*
Middle Aged
Palliative Care / methods*
Pancreatic Neoplasms / mortality,  therapy*
Prospective Studies
Stomach Neoplasms / mortality,  therapy*
Survival Analysis
Treatment Outcome
Comment In:
Gastrointest Endosc. 2010 Jan;71(1):220-1   [PMID:  20105481 ]
Erratum In:
Gastrointest Endosc. 2010 Sep;72(3):674

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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