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

Malignant Biliary Obstruction Clinical Trial

— BIGDIAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04405752
• Other study ID #: BIGDIAM-IPC 2018-056
• Status: Completed
• Start date: April 1, 2017
• Est. completion date: April 1, 2018

Study information

• Verified date: May 2020
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Malignant Biliary Obstruction

Intervention

Device:
• 12-mm metallic biliary stent
Metallic biliary stent, covered or uncovered,KEBOMED HILZO 12mm in diameter (length 4 or 6 cm).
• 10-mm metallic biliary stent
Biliary, metallic, covered or uncovered stent, COOK EVOLUTION 10mm in diameter (length 4 or 6 cm)

Locations

Country	Name	City	State
France	Institut Paoli Calmettes	Marseille	Bouches Du Rhône

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to recurrent biliary obstruction (RBO)	RBO is defined as the time from the prosthesis deployment to until the first biliary stent obstruction (patency	12 months