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COMPLETEDNA

ComVi and D-type Stent in Malignant GOO

A Newly Designed Conformable Uncovered Versus Covered Self-expandable Metallic Stent for Palliation of Malignant Gastric Outlet Obstruction: a Prospective, Randomized Multicenter Study

NCT01839292•Ajou University School of Medicine

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Ajou University Hospital

Suwon, South Korea

Key Dates

Start Date

April 1, 2010

Primary Completion Date

August 1, 2012

Last Updated

April 24, 2013

Enrollment

ACTUAL participants

Conditions

Gastric Outlet Obstruction

Interventions

uncovered D-type stent insertion

DEVICE

double-layered ComVi stent insertion

DEVICE

Roux-en-Y Gastric Bypass Versus Loop Gastrojejunostomy for Malignant Gastric Outlet Obstruction

NCT05986890

Malignant Gastric Outlet Obstruction

View study

RECRUITINGNA

Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.

NCT06128018

Malignant Gastric Outlet Obstruction

View study

ENROLLING_BY_INVITATIONNA

Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy

NCT06567691

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 24, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

ComVi and D-type Stent in Malignant GOO

Inclusion Criteria

Exclusion Criteria

Roux-en-Y Gastric Bypass Versus Loop Gastrojejunostomy for Malignant Gastric Outlet Obstruction

Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.

Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy

Randomized Trial of EUS-guided Gastrojejunostomy and Surgical Gastrojejunostomy in Gastric Outlet Obstruction

AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE

Partially Covered Versus Uncovered Pyloro-duodenal Stents for Unresectable Malignant Gastric Outlet Obstruction. A Double Blinded Randomised Controlled Trial.