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

Soon Chun Hyang University

Status: Completed

Conditions: Klatskin Tumor

Treatments: Device: Metallic stent deployment in hilar obstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT02166970

Hilar stenting

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age > 18 years
• inoperable hilar malignancy

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

Single stent deployment

Experimental group

Description:

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).

Treatment:

Device: Metallic stent deployment in hilar obstruction

Multiple stent deployment

Active Comparator group

Description:

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).

Treatment:

Device: Metallic stent deployment in hilar obstruction