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NCT05761496 Clinical Trial

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

Biliary Stricture Clinical Trial

— PROTESIED  

Official title:
Metal and Plastic Biliary Stents to Drain Malignant Distal Biliary Strictures. Registry of the Italian Society of Digestive Endoscopy.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05761496
Other study ID # 2767
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 7, 2020
Est. completion date January 1, 2024

Study information
Verified date March 2023
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Andrea Tringali, MD, PhD
Phone +39 3287372601
Email andrea.tringali@unicatt.it
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 750
Est. completion date January 1, 2024
Est. primary completion date February 25, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Biliary stents insertion
Endoscopic placement of plastic and metal biliary stents

Locations
Country Name City State
Italy Fondazione Policlinico Gemelli IRCCS Roma

Sponsors (1)
Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of the potency of biliary stents (plastic and metal) Time to occurrence of jaundice/cholangitis through study completion, an average of 1 year
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