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

Not Applicable

Completed

• Conditions: Malignant Biliary Obstruction
• Interventions: Procedure: metallic biliary stent insertion (double bare - S&G Biotech.); Procedure: metallic biliary stent insertion (single bare - S&G Biotech.); Procedure: metallic biliary stent insertion (single bare - Taewoong Medical.)

• Registration Number: NCT01869894
• Lead Sponsor: Yonsei University

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-05-29
• Study Start: 2013-06
• Study First Submitted QC: 2013-06-04
• Study First Posted: 2013-06-05
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-29
• Last Update Posted: 2015-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• The patients who had malignant biliary obstruction

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
uncovered double bare metallic stent (S&G Biotech.)	metallic biliary stent insertion (double bare - S&G Biotech.)	uncovered double bare metallic stent
uncovered single bare metallic stent (S&G Biotech.)	metallic biliary stent insertion (single bare - S&G Biotech.)	uncovered single bare metallic stent
uncovered single bare metallic stent (Taewoong Medical.)	metallic biliary stent insertion (single bare - Taewoong Medical.)	uncovered single bare metallic stent

Primary Outcome Measures

Name	Time	Method
Median patency duration	Approximately 6 months later since the date of stent insertion	Primary end point : A. Median patency duration

Secondary Outcome Measures

Name	Time	Method
6-months patency rate	Approximately 6 months later since the date of stent insertion	Secondary end point : A. 6-months patency rate

Trial Locations

Locations (1)

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of