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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Technical success of single or multiple stents [ Time Frame: 1 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