Skip to main content
OpenTrials
Completed

NCT Number: NCT04405752

Evaluation of a New Metal Biliary Stent of 12-mm Diameter: a Case Control Study

Biliary stent allows the drainage of the bile ducts palliatively or preoperatively in the event of malignant biliary stenosis, and a biliary calibration in the event of benign stenosis. Currently, by expert agreement, the diameter is 10-mm for metal stent. Since 2017, larger stents have been marketed in France and are approved for the biliary drainage of benign and malignant biliary stricture. These new 12-mm diameter stent could reduce the risk of recurrent biliary obstruction (RBO) and therefore increase the stent duration. The aim of our study was to compare whether the permeability of 12-mm diameter stent was better than a conventional 10-mm, covered or uncovered prosthesis depending on the indication.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Malignant Biliary Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Paoli Calmettes

Marseille, Bouches Du Rhône, 13273, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • benign and malignant biliary stricture of the lower or median portion of the main biliary duct with indication of biliary stent placement including pre-operatively drainage
  • age≥ 18 years old;
  • Karnofsky score ≥ 40.

Exclusion criteria

  • hilar stenosis;
  • coagulation disorder (PT <50%, platelets < 80,000).

Treatment and study plan

12-mm metallic biliary stent

Device

Metallic biliary stent, covered or uncovered,KEBOMED HILZO 12mm in diameter (length 4 or 6 cm).

10-mm metallic biliary stent

Device

Biliary, metallic, covered or uncovered stent, COOK EVOLUTION 10mm in diameter (length 4 or 6 cm)

Primary outcomes

  1. Time to recurrent biliary obstruction (RBO)

    Time frame: 12 months

    RBO is defined as the time from the prosthesis deployment to until the first biliary stent obstruction (patency

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Acronym: BIGDIAM

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 28, 2020
Registry last updated
May 28, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.