Clinical Trial: Percutaneous Bilateral Versus Unilateral Metal Stent for Hilar Cholangiocarcinoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Percutaneous Bilateral Versus Unilateral Metal Stent Placement for Hilar Cholangiocarcinoma : A Prospective Open-label Randomized Controlled Trial

Brief Summary:

Cholangiocarcinoma (CCA) is the most common biliary malignancy and the second most common hepatic malignancy after hepatocellular carcinoma (HCC). A majority of the CCA (50-70%) was presented in the area of the biliary duct bifurcation. Recent retrospective study included heterogeneous group of malignant diseases demonstrate that draining more than 50% of was associated with a longer median survival.

However, in recent European Society of Gastrointestinal Endoscopy (ESGE) biliary stenting clinical guideline and Asia-Pacific consensus recommendations for endoscopic and interventional management of hilar cholangiocarcinoma (HCCA), whether we should deployment bilateral or unilateral metal stent for patients with HCCA was not clearly recommended due to the absence of randomized controlled trials.


Detailed Summary:

Patients with advanced hilar obstruction (Bismuth III and IV), PTBS had a higher success rate of cholestasis palliation and a low rate of post cholangitis when compared with endoscopic retrograde cholangiopancreatography(ERCP). The advantage of percutaneous approach is the precise lobar selection for drainage and this approach should yield a lower rate of cholangitis.

Guideline recommendation European Society of Gastrointestinal Endoscopy (ESGE) biliary stenting clinical guideline and Asia-Pacific consensus recommendations the goal of palliative stenting of HCCA is drainage of adequate liver volume (50% or more), irrespective of unilateral, bilateral, or multi-segmental stenting was based on heterogeneous group of malignancy by ERCP in retrospective study.There are no randomized clinical trials compared with these two internal biliary drainage methods in HCCA using metal stent.

The aim of the present study was to compare the effect and safety of bilateral versus unilateral stenting in patients with HCCA.


Sponsor: Fourth Military Medical University

Current Primary Outcome: Failure to control jaundice or failure to prevent stent occlusion or re-jaundice within three month after stent implantation [ Time Frame: From stent insertion to three months ]

Original Primary Outcome: Successful drainage [ Time Frame: From stent insertion to two weeks ]

Successful drainage is a primary endpoint of this study. Successful drainage rate is compared between the two groups.


Current Secondary Outcome: Median survival [ Time Frame: up to 1 year ]

Original Secondary Outcome: Same as current

Information By: Fourth Military Medical University

Dates:
Date Received: March 31, 2014
Date Started: July 2014
Date Completion: June 2017
Last Updated: December 19, 2014
Last Verified: April 2014