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

Completed

• Conditions: Malignant Biliary Obstruction
• Interventions: Device: 10-mm metallic biliary stent; Device: 12-mm metallic biliary stent

• Registration Number: NCT04405752
• Lead Sponsor: Institut Paoli-Calmettes

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-01
• Primary Completion: 2018-04-01
• Study Completion: 2018-04-01
• Status Verified: 2020-05
• Study First Submitted: 2020-05-22
• Study First Submitted QC: 2020-05-22
• Last Update Submitted: 2020-05-22
• Study First Posted: 2020-05-28
• Last Update Posted: 2020-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
10-mm diameter metallic billiary stent	10-mm metallic biliary stent	-
12-mm diameter metallic billiary stent	12-mm metallic biliary stent	-

Primary Outcome Measures

Name	Time	Method
Time to recurrent biliary obstruction (RBO)	12 months	RBO is defined as the time from the prosthesis deployment to until the first biliary stent obstruction (patency

Trial Locations

Locations (1)

Institut Paoli Calmettes; 🇫🇷 Marseille, Bouches Du Rhône, France