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NCT05761483 Clinical Trial

Endoscopic Management of Non-anastomotic Biliary Strictures Following Liver Transplantation.

Biliary Stricture Clinical Trial

— STEBINANSIED  

Official title:
Endoscopic Management of Non-anastomotic Biliary Strictures Following Liver Transplantation. Registry of the Italian Society of Digestive Endoscopy.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05761483
Other study ID # 2766
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 12, 2020
Est. completion date January 1, 2027

Study information
Verified date March 2023
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Andrea Tringali, MD, PD
Phone +393287372601
Email andrea.tringali@unicatt.it
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The study will evaluate the results of endoscopic treatment of NON-anastomotic biliary strictures following liver transplantation

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date January 1, 2027
Est. primary completion date February 22, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age > 18 - Non anastomotic biliary strictures diagnosed by direct cholangiogram (T-tube) or MRCP - Stricture involving the hepatic hilum until secondary branches - Increase of liver function tests - Signature of the informed consent Exclusion Criteria: - Previopus endoscopic or percutaneous treatments - Patient candidate to metal stents placement - Previous surgery resulting in altered anatomy

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• ERCP
Endoscopic Retrograde Cholangiopancreatography, placement of stents using a duodenoscope and making an access through the papilla of Vater

Locations
Country Name City State
Italy Fondazione Policlinico Gemelli IRCCS Roma RM

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 endoscopic treatment of non-anastomosis biliary strictures Evaluate biliary stricture resolution rate 2 Years follow-up
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