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

Kwang Hyuck Lee

Status: Withdrawn

Conditions: Obstruction of Biliary Tree; Gall Bladder Cancer; Hepatocellular Carcinoma; Cholangiocarcinoma; Malignant Lymphadenopathy

Treatments: Device: stent insertion; Procedure: Endoscopic retrograde cholangiopancreatoscopy(ERCP)

Study type: Interventional

Funder types: Other

Identifiers

NCT01875549

2013-03-014-002

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Unilateral stent insertion group

Active Comparator group

Description:

the use of unilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP)

Treatment:

Procedure: Endoscopic retrograde cholangiopancreatoscopy(ERCP)

Device: stent insertion

Bilateral stent insertion group

Active Comparator group

Description:

the use of bilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP)

Treatment:

Procedure: Endoscopic retrograde cholangiopancreatoscopy(ERCP)

Device: stent insertion