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

Not Applicable

Completed

• Conditions: Klatskin Tumor
• Interventions: Device: Metallic stent deployment in hilar obstruction

• Registration Number: NCT02166970
• Lead Sponsor: Soon Chun Hyang University

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 Description

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.

Study Timeline

• Study Start: 2014-03-01
• Study First Submitted: 2014-06-13
• Study First Submitted QC: 2014-06-16
• Study First Posted: 2014-06-18
• Primary Completion: 2016-02-28
• Study Completion: 2016-10-30
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• age > 18 years
• inoperable hilar malignancy

Exclusion Criteria

• age under 18 years
• uncontrolled coagulopathy
• inability to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single stent deployment	Metallic stent deployment in hilar obstruction	Metallic stent deployment in hilar obstruction. Insertion of metallic stent to the dominant targeted duct such as right anterior (segments V and VIII), right posterior (segments VI and VII) or left (segments II-IV).
Multiple stent deployment	Metallic stent deployment in hilar obstruction	Metallic stent deployment in hilar obstruction. Insertion of multiple metallic stent to the dominant targeted duct such as right anterior (segments V and VIII), right posterior (segments VI and VII) or left (segments II-IV).

Primary Outcome Measures

Name	Time	Method
Reintervention rate when stents occluded	2 years	When the stents occluded after successful single or multiple stent deployment, the outcome measure is assessed.

Secondary Outcome Measures

Name	Time	Method
Technical success of single or multiple stents	1 month	When the bilirubin level decrease more than 50% within one week or 75% within one month.

Trial Locations

Locations (1)

Tae Hoon Lee; 🇰🇷 Cheonan, Korea, Republic of