Malignant Biliary Obstruction Clinical Trial
— BIGDIAMOfficial title:
Evaluation of a New Metal Biliary Stent of 12-mm Diameter: a Case Control Study
Verified date | May 2020 |
Source | Institut Paoli-Calmettes |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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). |
Country | Name | City | State |
---|---|---|---|
France | Institut Paoli Calmettes | Marseille | Bouches Du Rhône |
Lead Sponsor | Collaborator |
---|---|
Institut Paoli-Calmettes |
France,
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 |
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