Clinical Trial: Single Versus Multiple Deployment of Metallic Stents for Inoperable Malignant Hilar Biliary Obstruction

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Single Versus Multiple Deployment of Metallic Stents for Inoperable Malignant Hilar Biliary Obstruction: A Multicenter Prospective Randomized Study

Brief Summary: In Bismuth II-IV hilar cholangiocarcinoma patients with a predicted survival of longer than 3 months, metallic stent performance is superior to plastic stenting for palliation with respect to outcomes and cost-effectiveness. However, the optimal stent type and the extent of drainage are issues that remain to be definitively decided. The optimal endoscopic management strategy is contentious. The investigators conduct the present study to prospectively in multi-centers compare unilateral (single) with bilateral (multiple) deployment in inoperable malignant biliary obstructions to clarify the clinical outcomes of these two deployment methods using metallic stents.

Detailed Summary:

In Bismuth II-IV hilar cholangiocarcinoma patients with a predicted survival of longer than 3 months, metallic stent performance is superior to plastic stenting for palliation with respect to outcomes and cost-effectiveness.

However, the optimal stent type and the extent of drainage are issues that remain to be definitively decided. The optimal endoscopic management strategy is contentious.

The investigators conduct the present study to prospectively in multi-centers compare unilateral (single) with bilateral (multiple) deployment in inoperable malignant biliary obstructions to clarify the clinical outcomes of these two deployment methods using metallic stents.

First as an unilateral or bilateral stent will be deployed according to criteria.

In bilateral group, stent-in-stent or side-by-side deployment will be included.


Sponsor: Soon Chun Hyang University

Current Primary Outcome: Reintervention rate when stents occluded [ Time Frame: 2 years ]

When the stents occluded after successful single or multiple stent deployment, the outcome measure is assessed.


Original Primary Outcome: Same as current

Current Secondary Outcome: Technical success of single or multiple stents [ Time Frame: 1 month ]

When the bilirubin level decrease more than 50% within one week or 75% within one month.


Original Secondary Outcome: Same as current

Information By: Soon Chun Hyang University

Dates:
Date Received: June 13, 2014
Date Started: March 1, 2014
Date Completion:
Last Updated: February 27, 2017
Last Verified: February 2017