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

NCT ID: NCT04405752

Last Updated: 2020-05-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 72 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2018-04-01

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.

Conditions

Malignant Biliary Obstruction

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

12-mm diameter metallic billiary stent

12-mm metallic biliary stent

Intervention Type: DEVICE

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

10-mm diameter metallic billiary stent

10-mm metallic biliary stent

Intervention Type: DEVICE

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

Interventions

12-mm metallic biliary stent

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

Intervention Type: DEVICE

10-mm metallic biliary stent

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

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Paoli-Calmettes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabrice Caillol

Role: PRINCIPAL_INVESTIGATOR

Institut Paoli-Calmettes

Locations

Institut Paoli Calmettes

Marseille, Bouches Du Rhône, France

Countries

France

Other Identifiers

BIGDIAM-IPC 2018-056

Identifier Type: -

Identifier Source: org_study_id