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Clinical Trials/NCT01869894
NCT01869894
Completed
Not Applicable

A Prospective Randomized Study for Efficacy of Uncovered Double Bare Metallic Stent Compared to Uncovered Single Bare Metallic Stent in Malignant Biliary Obstruction

Yonsei University1 site in 1 country73 target enrollmentJune 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Malignant Biliary Obstruction
Sponsor
Yonsei University
Enrollment
73
Locations
1
Primary Endpoint
Median patency duration
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Our study is the prospective randomized study for efficacy of uncovered double bare metallic stent compared to uncovered single bare metallic stent in malignant biliary obstruction

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
June 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • The patients who had malignant biliary obstruction

Exclusion Criteria

  • The patients who had resectable biliary malignancy
  • The patients who had hilar obstruction
  • The patients who had duodenal obstruction
  • The patients who had other malignancy which is not related to biliary obstruction
  • The patients who had uncontrolled infection
  • The patients who had poor performance (ECOG =3 or 4)
  • The patients who were not acquired informed consent
  • The patients who had technically difficult structure for ERCP

Outcomes

Primary Outcomes

Median patency duration

Time Frame: Approximately 6 months later since the date of stent insertion

Primary end point : A. Median patency duration

Secondary Outcomes

  • 6-months patency rate(Approximately 6 months later since the date of stent insertion)

Study Sites (1)

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