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

Hepatocellular Carcinoma Clinical Trial

Official title:

Comparison Between Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a Large Cell Niti-S (LCD) Stent

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01875549
• Other study ID #: 2013-03-014-002
• Status: Withdrawn
• Phase: N/A
• First received: June 4, 2013
• Last updated: April 24, 2016
• Start date: May 2013
• Est. completion date: May 2016

Study information

• Verified date: April 2016
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Cholangiocarcinoma
• Gall Bladder Cancer
• Hepatocellular Carcinoma
• Malignant Lymphadenopathy
• Obstruction of Biliary Tree

Intervention

Device:
• stent insertion
to use a LCD stent at an unilateral or bilateral stent insertion

Procedure:
• Endoscopic retrograde cholangiopancreatoscopy(ERCP)
to use ERCP for a stent insertion in an obstructive biliary tract

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kwang Hyuck Lee

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	complication	Participants will followed after stent insertion and observe a complication rate between two groups.	up to 1year	Yes
Primary	Stent patency	Participants will followed for the new obstruction(new jaundice) will occur.	up to 1year	Yes
Secondary	survival period	Participants will followed for 1year.	up to 1year	Yes