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OpenTrials
Completed

NCT Number: NCT01839292

ComVi and D-type Stent in Malignant GOO

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.

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Key information

Conditions

Gastric Outlet Obstruction Digestive System Diseases Gastrointestinal Diseases Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ajou University Hospital

Suwon, 443-721, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

uncovered D-type stent insertion

Device

double-layered ComVi stent insertion

Device

Primary outcomes

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

    Time frame: Up to 1 years

Secondary outcomes

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

    Time frame: up to 1 years

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Collaborators

  • DongGuk University
  • Hallym University
  • Kyungpook National University Hospital
  • National Cancer Center, Korea
  • Seoul National University
  • The Catholic University of Korea

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
First posted
Apr 24, 2013
Registry last updated
Apr 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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