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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04405752
Other study ID # BIGDIAM-IPC 2018-056
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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