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

NCT02166970 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2017-03-01

No results posted yet for this study

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.

Conditions

  • Klatskin Tumor

Interventions

DEVICE

Metallic stent deployment in hilar obstruction

Single stent insertion: metal stent deployment to right or left intrahepatic duct Multiple stenting: Stent-in-stent or side-by-side deployment

Sponsors & Collaborators

  • Soon Chun Hyang University

    lead OTHER

Principal Investigators

  • Tae Hoon Lee, MD, PhD · SoonChunHyang University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-01
Primary Completion
2016-02-28
Completion
2016-10-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02166970 on ClinicalTrials.gov