NCT04405752

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 72 (actual)
• Sponsor: Institut Paoli-Calmettes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Biliary Obstruction

Interventions

Type	Name	Description
DEVICE	12-mm metallic biliary stent	Metallic biliary stent, covered or uncovered,KEBOMED HILZO 12mm in diameter (length 4 or 6 cm).
DEVICE	10-mm metallic biliary stent	Biliary, metallic, covered or uncovered stent, COOK EVOLUTION 10mm in diameter (length 4 or 6 cm)

Timeline

• Start date: 2017-04-01
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2020-05-28
• Last updated: 2020-05-28

Locations

1 site across 1 country: France