Comparison Between Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a LCD Stent

Not Applicable

Withdrawn

• Conditions: Gall Bladder Cancer; Hepatocellular Carcinoma; Cholangiocarcinoma; Obstruction of Biliary Tree; Malignant Lymphadenopathy
• Interventions: Device: stent insertion; Procedure: Endoscopic retrograde cholangiopancreatoscopy(ERCP)

• Registration Number: NCT01875549
• Lead Sponsor: Kwang Hyuck Lee

Brief Summary

Internal biliary drainage is an useful method for a control of jaundice and cholangitis to patients who had a malignant hilar obstruction due to hepatocellular carcinoma, cholangiocarcinoma, gall bladder cancer or metastatic lymphadenopathy.

Bilateral biliary drainage is more physiologic but technically difficult to compared with unilateral biliary drainage specially related to conformability and flexibility between using stents.

There are no prospective clinical trials compared with these internal biliary drainage methods in hilar malignant obstruction using metal stent.

Therefore, the investigators want to compare the clinical outcome of two method: Unilateral biliary stent and Bilateral biliary stent

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-06-11
• Study First Posted: 2013-06-12
• Primary Completion: 2015-05
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-24
• Last Update Posted: 2016-04-26
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: WITHDRAWN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

Inclusion Criteria

• Age> 18
• diagnosis of malignancy in pathology or cytology
• jaundice(Total bilirubin)> 2.0 mg/dL
• Diagnosed malignant hilar invasion to CT or other image finding

Exclusion Criteria

• bleeding tendency(INR>1.5)
• Pregnancy
• severe liver,kidney disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bilateral stent insertion group	stent insertion	the use of bilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP)
Bilateral stent insertion group	Endoscopic retrograde cholangiopancreatoscopy(ERCP)	the use of bilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP)
Unilateral stent insertion group	stent insertion	the use of unilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP)
Unilateral stent insertion group	Endoscopic retrograde cholangiopancreatoscopy(ERCP)	the use of unilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP)

Primary Outcome Measures

Name	Time	Method
Stent patency	up to 1year	Participants will followed for the new obstruction(new jaundice) will occur.

Secondary Outcome Measures

Name	Time	Method
survival period	up to 1year	Participants will followed for 1year.