ComVi and D-type Stent in Malignant GOO

Gastric Outlet Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839292
• Other study ID #: AJIRB-DEV-DE4-10-009
• Status: Completed
• Phase: N/A
• First received: April 18, 2013
• Last updated: April 22, 2013
• Start date: April 2010

Study information

• Verified date: April 2013
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Gastric Outlet Obstruction
• Pyloric Stenosis

Intervention

Device:
• uncovered D-type stent insertion

• double-layered ComVi stent insertion

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (7)

Lead Sponsor	Collaborator
Ajou University School of Medicine	DongGuk University, Hallym University, Kyungpook National University, National Cancer Center, Korea, Seoul National University, The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the stent patency time from stent insertion to restenosis due to stent malfunction or death		Up to 1 years	No
Secondary	stent malfunction (e.g., stent migration or occlusion due to tumor ingrowth/overgrowth) and the reintervention rate		up to 1 years	No