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

NCT01875549 | Withdrawn DMC

• 1 other identifier: 2013-03-014-002
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Stent patency

  Participants will followed for the new obstruction(new jaundice) will occur.

  up to 1year

Secondary Outcomes (1)

• survival period

  up to 1year

Other Outcomes (1)

• complication

  up to 1year

Study Arms (2)

Unilateral stent insertion group

ACTIVE COMPARATOR

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

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

Bilateral stent insertion group

ACTIVE COMPARATOR

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

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

Interventions

stent insertion DEVICE

to use a LCD stent at an unilateral or bilateral stent insertion

Also known as: Niti-S large cell D-type biliary stent [LCD]

Bilateral stent insertion group; Unilateral stent insertion group

Endoscopic retrograde cholangiopancreatoscopy(ERCP) PROCEDURE

to use ERCP for a stent insertion in an obstructive biliary tract

Bilateral stent insertion group; Unilateral stent insertion group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kwang Hyuck Lee: lead

MeSH Terms

Conditions

Cholangiocarcinoma; Carcinoma, Hepatocellular; Gallbladder Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Biliary Tract Neoplasms; Biliary Tract Diseases; Gallbladder Diseases

Study Officials

• Kwang hyuck Lee, PhD

  Division of Gastroenterology,Department of internal medicaion,samsung medical center,Sungkyunkwan University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 12, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2016
• Last Updated: April 26, 2016

Record last verified: 2016-04