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

NCT04405752 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 72

Last updated 2020-05-28

No results posted yet for this study

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

Interventions

DEVICE

12-mm metallic biliary stent

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

DEVICE

10-mm metallic biliary stent

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

Sponsors & Collaborators

  • Institut Paoli-Calmettes

    lead OTHER

Principal Investigators

  • Fabrice Caillol · Institut Paoli-Calmettes

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2018-04-01
Completion
2018-04-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04405752 on ClinicalTrials.gov