Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction

Phase 3

Withdrawn

• Conditions: Bile Duct Neoplasm; Obstructive Jaundice
• Interventions: Procedure: parallel stent; Device: Y-stent (BONASTENT M-Hilar)

• Registration Number: NCT01622803
• Lead Sponsor: Samsung Medical Center

Brief Summary

Internal biliary drainage using stent is used for malignant hilar obstruction such as cholangiocarcinoma, hepatocellular carcinoma and other malignancy including metastasis.

Bilateral drainage is more physiologic and have more long patency than unilateral drainage.

There are two methods of bilateral drainage: Y-stent and side by side.

However there are no clinical data about comparing the effectiveness of these two methods.

Therefore the investigators want to compare the clinical outcomes of two methods:

Y-stent and side by side.

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 Start: 2011-08
• Study First Submitted: 2012-06-12
• Study First Submitted QC: 2012-06-18
• Study First Posted: 2012-06-19
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-24
• Last Update Posted: 2016-04-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• age ≥ 18 years
• patient who have obstructive jaundice (bilirubin > 2.0mg/dl) due to hilar malignancy

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Exclusion Criteria

• patients with endoscopic retrograde cholangiogram is not possible
• bleeding tendency (PT INR > 1.5, platelet < 50,000)
• poor general condition (ECOG 3-4) or cardiopulmonary deterioration
• pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
parallel stent	parallel stent	parallel stent insertion group
Y-stent	Y-stent (BONASTENT M-Hilar)	Y-stent insertion group

Primary Outcome Measures

Name	Time	Method
The time taken to insert bilateral stent	After the ERCP procedure

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of