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

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• 作者：Jeanin E. van Hooft ; Madeleen J. Uitdehaag ; Marco J. Bruno ; Robin Timmer ; Peter D. Siersema ; Marcel G.W. Dijkgraaf ; Paul Fockens
• 刊名：Gastrointestinal Endoscopy
• 出版年：2009
• 出版时间：May 2009
• 年：2009
• 卷：69
• 期：6
• 页码：1059-1066
• 全文大小：353 K

文摘

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.