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Completed

NCT Number: NCT02166970

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

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.

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Key information

Conditions

Klatskin Tumor Adenocarcinoma Carcinoma Cholangiocarcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tae Hoon Lee

Cheonan, 330721, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age > 18 years
  • inoperable hilar malignancy

Exclusion criteria

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

Treatment and study plan

Metallic stent deployment in hilar obstruction

Device

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

Other names: Single stent insertion, Multiple stent insertion using stent-in-stent method, Multiple stent insertion using side-by-side method

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Soon Chun Hyang University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 18, 2014
Registry last updated
Mar 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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