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

Institut Paoli-Calmettes

Status: Completed

Conditions: Malignant Biliary Obstruction

Treatments: Device: 12-mm metallic biliary stent; Device: 10-mm metallic biliary stent

Study type: Observational

Funder types: Other

Identifiers

NCT04405752

BIGDIAM-IPC 2018-056

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

72 participants in 2 patient groups

12-mm diameter metallic billiary stent

Treatment:

Device: 12-mm metallic biliary stent

10-mm diameter metallic billiary stent

Treatment:

Device: 10-mm metallic biliary stent