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

NCT04405752 | Completed

• 1 other identifier: BIGDIAM-IPC 2018-056
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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

Keywords

biliary stent; malignant biliary stenosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

12-mm diameter metallic billiary stent

Device: 12-mm metallic biliary stent

10-mm diameter metallic billiary stent

Device: 10-mm metallic biliary stent

Interventions

12-mm metallic biliary stent DEVICE

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

12-mm diameter metallic billiary stent

10-mm metallic biliary stent DEVICE

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

10-mm diameter metallic billiary stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• hilar stenosis;
• coagulation disorder (PT \<50%, platelets \< 80,000).

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Institut Paoli Calmettes

Marseille, Bouches Du Rhône, 13273, France

Location

Study Officials

• Fabrice Caillol

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 28, 2020
• Study Start: April 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: May 28, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)