Skip to main content
MedPathMedPath Home
Clinical Trials/NCT05220475
NCT05220475
Recruiting
Not Applicable

A Comparison of a Fully Covered Self-expandable Metal Stent With an External Anchoring Plastic Stent and Uncovered Stent: Prospective Randomized Multicenter Study

Seoul National University Hospital1 site in 1 country108 target enrollmentOctober 25, 2021
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsMalignant Biliary Obstruction

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Malignant Biliary Obstruction
Sponsor
Seoul National University Hospital
Enrollment
108
Locations
1
Primary Endpoint
Rate of patent stent
Status
Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

Multi-center, randomized controlled study fc-SEMS with anchoring plastic stent vs uc-SEMS in malignant biliary obstruction

Detailed Description

This study is multi-center, randomized controlled study to compare the stent patency in malignant biliary obstruction. The patency of fully covered self expandable metal stent with external anchoring plastic stent was compared with that of uncovered self expandable metal stent.

Registry
clinicaltrials.gov
Start Date
October 25, 2021
End Date
October 24, 2024
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sang Hyub Lee

Professor

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

  • •Adults with 19 years of age or older
  • •Those who voluntarily consented to the trial and signed a written consent
  • •Inoperable malignant biliary obstruction

Exclusion Criteria

  • •Previous surgical biliary drainage
  • •Patients continuosly requiring percutaneous transhepatic biliary drainage
  • •History of biliary drainage with metal stent
  • •Biliary obstruction located in hilum or intrahepatic duct
  • •Patients with life expectancy of 3 months or less
  • •On pregnancy
  • •Unable to underwent endoscopic procedures

Outcomes

Primary Outcomes

Rate of patent stent

Time Frame: 1 year

The number of patient without stent dysfuction divided by total number of patients

Secondary Outcomes

  • Adverse event(1 year)
  • Stent migration(1 year)
  • Stent obstruction(1 year)
  • Overall survival(1 year)
  • Re-intervention(1 year)

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis StudyBiliary Stricture
NCT01543256Boston Scientific Corporation172
Recruiting
Not Applicable
Self-expandable Metal Stent (SEMS) Endoscopic Placement for Malignant Colonic Obstruction TherapyNeoplasms,Colorectal
NCT05643989Russian Society of Colorectal Surgeons56
Completed
Not Applicable
Efficacy of Endoscopic Covered Metal Stenting for Malignant Gastric Outlet Obstructio
JPRN-UMIN000020539agoya City University Graduate School of Medical Sciences126
Completed
Not Applicable
Predictors of stent dysfunction after self-expandable metal stent placement for malignant gastric outlet obstructioMalignant gastric outlet obstruction (GOO)
JPRN-UMIN000024059agoya City University Graduate School of Medical Sciences252
Completed
Not Applicable
EUS-guided Transmural Drainage of Walled-off Pancreatic Necrosis: Plastic vs Metallic Protesis.Pancreas NecrosisPancreatic Collection
NCT03100578Hospital Universitari de Bellvitge99