ComVi and D-type Stent in Malignant GOO

Not Applicable

Completed

• Conditions: Gastric Outlet Obstruction
• Interventions: Device: uncovered D-type stent insertion; Device: double-layered ComVi stent insertion

• Registration Number: NCT01839292
• Lead Sponsor: Ajou University School of Medicine

Brief Summary

Covered self-expandable metallic stents (SEMS) have been used to prevent tumor ingrowth, a common complication of uncovered SEMSs. However, they have revealed a high incidence of stent migration in patients with unresectable malignant gastric outlet obstruction (GOO). A conformable covered SEMS was introduced to overcome both stent migration and tumor ingrowth. The aims of this study were to evaluate the clinical outcomes of newly designed conformable covered and uncovered SEMS for palliation of malignant GOO.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2012-08
• Status Verified: 2013-04
• Study First Submitted: 2013-04-18
• Study First Submitted QC: 2013-04-22
• Last Update Submitted: 2013-04-22
• Study First Posted: 2013-04-24
• Last Update Posted: 2013-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

• adults 18 years of age or older
• obstructive symptoms due to unresectable malignant GOO
• a Karnofsky performance score of more than 30 (13)

Exclusion Criteria

• history of a previous SEMS insertion
• the presence of obstruction in the gastrointestinal tract excluding the gastric outlet
• severe comorbidities precluding the endoscopic procedure, such as cardiopulmonary disease, sepsis, and bleeding disorders
• a life expectancy of less than 1 month after SEMS insertion
• history of gastric surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
uncovered D-type stent	uncovered D-type stent insertion	uncovered D-type stent, which effectively reduces stent migration, especially in malignant colorectal obstruction
double-layered ComVi stent	double-layered ComVi stent insertion	double-layered ComVi stent, which is a modified covered stent with an additional outer bare wire mesh to overcome both tumor ingrowth and stent migration

Primary Outcome Measures

Name	Time	Method
the stent patency time from stent insertion to restenosis due to stent malfunction or death	Up to 1 years

Secondary Outcome Measures

Name	Time	Method
stent malfunction (e.g., stent migration or occlusion due to tumor ingrowth/overgrowth) and the reintervention rate	up to 1 years

Trial Locations

Locations (1)

Ajou University Hospital; 🇰🇷 Suwon, Korea, Republic of