Unknown statusInterventionalNot ApplicableUpdated Jan 20, 2021
A Prospective Randomized Study for Efficacy of Uncovered Double Bare Metallic Stent Compared to Uncovered Single Bare Metallic Stent in Malignant... | NCT01869894 | Trialant
CompletedInterventionalNot ApplicableUpdated Oct 1, 2015
A Prospective Randomized Study for Efficacy of Uncovered Double Bare Metallic Stent Compared to Uncovered Single Bare Metallic Stent in Malignant Biliary Obstruction
ClinicalTrials.gov ID
NCT01869894
Lead Sponsor
Yonsei UniversityOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
73Actual
Last Update Posted
Oct 1, 2015Estimated
Start Date
Jun 2013
Primary Completion Date
Jun 2014Actual
Completion Date
Jun 2014Actual
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
Malignant Biliary Obstruction
metallic biliary stent insertion (double bare - S&G Biotech.)
metallic biliary stent insertion (single bare - S&G Biotech.)
metallic biliary stent insertion (single bare - Taewoong Medical.)
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
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
Primary Purpose
Treatment
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Single
No central contacts
There are no central contacts for this study.
Severance Hospital, Yonsei University Health System