Metal and Plastic Biliary Stents to Drain Malignant Distal Biliary Strictures.

Completed

• Conditions: Biliary Stricture; Stent Stenosis

• Registration Number: NCT05761496
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

Multicentric Italian registry aimed to evaluated the role and results of plastic and metal stents in the treatment of malignant distal biliary strictures

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-07
• Primary Completion: 2022-07-31
• Study Completion: 2022-12-31
• Study First Submitted: 2023-02-25
• Study First Submitted QC: 2023-03-07
• Study First Posted: 2023-03-09
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 871

Inclusion Criteria

• Malignant distal biliary stricture
• Need for Palliative and pre-operative biliary drainage
• Age > 18
• Signature of the informed consent

Exclusion Criteria

• Previous endoscopic/radiological biliary drainage
• Stricture close to the main hepatic confluence(< 2 cm)
• Duodenal stenosis
• Post- surgical altered anatomy
• Benign disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the potency of biliary stents (plastic and metal)	through study completion, an average of 1 year	Time to occurrence of jaundice/cholangitis

Trial Locations

Locations (1)

Fondazione Policlinico Gemelli IRCCS; 🇮🇹 Roma, Italy