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


METHODS
Prospective multicenter cohort study.


METHODS
Three tertiary referral centers (2 academic).


METHODS
Fifty-one consecutive patients with symptomatic malignant GOO from January 2005 to February 2006.


METHODS
Placement of a self-expandable metallic stent (WallFlex).


METHODS
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%).


CONCLUSIONS
Lack of a control group.


CONCLUSIONS
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.
van Hooft
Jeanin E
JE
Academic Medical Center, Amsterdam, Netherlands. j.e.vanhooft@amc.nl
Uitdehaag
Madeleen J
MJ
Bruno
Marco J
MJ
Timmer
Robin
R
Siersema
Peter D
PD
Dijkgraaf
Marcel G W
MG
Fockens
Paul
P
D000203:Activities of Daily Living / Q000145:classification; D000368:Aged; D000369:Aged, 80 and over; D014670:Ampulla of Vater; D015992:Body Mass Index; D018281:Cholangiocarcinoma / Q000401:mortality / Q000628:therapy*; D015331:Cohort Studies; D003138:Common Bile Duct Neoplasms / Q000401:mortality / Q000628:therapy*; D004379:Duodenal Neoplasms / Q000401:mortality / Q000628:therapy*; D019544:Equipment Failure Analysis; D004869:Equipment Safety; D005260:Female; D005500:Follow-Up Studies; D017219:Gastric Outlet Obstruction / Q000401:mortality / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010166:Palliative Care / Q000379:methods*; D010190:Pancreatic Neoplasms / Q000401:mortality / Q000628:therapy*; D011446:Prospective Studies; D015607:Stents; D013274:Stomach Neoplasms / Q000401:mortality / Q000628:therapy*; D016019:Survival Analysis; D016896:Treatment Outcome