ComVi and D-type Stent in Malignant GOO

NCT01839292 | Completed DMC

• 1 other identifier: AJIRB-DEV-DE4-10-009
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Outlet Obstruction

Keywords

gastric outlet obstruction; palliative treatment; stent

Outcome Measures

Primary Outcomes (1)

• the stent patency time from stent insertion to restenosis due to stent malfunction or death

  Up to 1 years

Secondary Outcomes (1)

• stent malfunction (e.g., stent migration or occlusion due to tumor ingrowth/overgrowth) and the reintervention rate

  up to 1 years

Study Arms (2)

uncovered D-type stent

ACTIVE COMPARATOR

uncovered D-type stent, which effectively reduces stent migration, especially in malignant colorectal obstruction

Device: uncovered D-type stent insertion

double-layered ComVi stent

ACTIVE COMPARATOR

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

Device: double-layered ComVi stent insertion

Interventions

uncovered D-type stent insertion DEVICE

uncovered D-type stent

double-layered ComVi stent insertion DEVICE

double-layered ComVi stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ajou University School of Medicine: lead
• National Cancer Center, Korea: collaborator
• Kyungpook National University Hospital: collaborator
• Hallym University: collaborator
• The Catholic University of Korea: collaborator
• Seoul National University: collaborator
• DongGuk University: collaborator

Study Sites (1)

Ajou University Hospital

Suwon, 443-721, South Korea

Location

MeSH Terms

Conditions

Gastric Outlet Obstruction

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Jin Hong Kim, M.D., Ph.D.

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: April 24, 2013
• Study Start: April 1, 2010
• Primary Completion: August 1, 2012
• Last Updated: April 24, 2013

Record last verified: 2013-04

Locations

KR (1)