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

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.

Study Overview

• Status: Completed
• Conditions: Malignant Biliary Obstruction
• Intervention / Treatment: Device: 12-mm metallic biliary stent; Device: 10-mm metallic biliary stent

• Study Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• France
  • Bouches Du Rhône
    • Marseille, Bouches Du Rhône, France, 13273
      • Institut Paoli Calmettes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

From April 2017 to April 2018, at the Paoli Calmettes Institute, 24 patients with benign or malignant biliary strictures were treated by placing a metallic biliary stent, covered or uncovered, KEBOMED HILZO 12mm in diameter (length 4 or 6 cm).

"Control" patients, who had benefited from the placement of a biliary, metallic, covered or uncovered stent, COOK EVOLUTION 10mm in diameter (length 4 or 6 cm) were searched on a database (ConsortConsore®️)extending from January 2016 to March 2018. "Cases" patients were exactly matched in a ratio 1:2 to "control" on the following criteria: age (per decade), sex, pathology responsible for biliary stenosis (i.e., benign or malignant stenosis) and type of stent (i.e., covered/uncovered). When we searched for control patients in our database, the first patient with matching criteria was included.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
12-mm diameter metallic billiary stent	Device: 12-mm metallic biliary stent; Metallic biliary stent, covered or uncovered,KEBOMED HILZO 12mm in diameter (length 4 or 6 cm).
10-mm diameter metallic billiary stent	Device: 10-mm metallic biliary stent; Biliary, metallic, covered or uncovered stent, COOK EVOLUTION 10mm in diameter (length 4 or 6 cm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Institut Paoli-Calmettes
• Investigators: Principal Investigator: Fabrice CAILLOL, Institut Paoli-Calmettes

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: May 22, 2020
• First Posted (Actual): May 28, 2020

Study Record Updates

• Last Update Posted (Actual): May 28, 2020
• Last Update Submitted That Met QC Criteria: May 22, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: biliary stent; malignant biliary stenosis
• Other Study ID Numbers: BIGDIAM-IPC 2018-056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No