- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05761483
Endoscopic Management of Non-anastomotic Biliary Strictures Following Liver Transplantation. (STEBINANSIED)
January 27, 2026 updated by: Tringali Andrea, MD, PhD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Endoscopic Management of Non-anastomotic Biliary Strictures Following Liver Transplantation. Registry of the Italian Society of Digestive Endoscopy.
The study will evaluate the results of endoscopic treatment of NON-anastomotic biliary strictures following liver transplantation
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Andrea Tringali, MD, PD
- Phone Number: +393287372601
- Email: andrea.tringali@unicatt.it
Study Locations
-
-
RM
-
Roma, RM, Italy, 00168
- Recruiting
- Fondazione Policlinico Gemelli IRCCS
-
Contact:
- Andrea Tringali
- Phone Number: +393287372601
- Email: andrea.tringali@unicatt.it
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients that underwent liver transplantation and has a diagnosis of biliary strictures secondary to ischemic cholangiopaty (biliary stenoses involving bile ducts of the donor and extending to the hilum)
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of endoscopic treatment of non-anastomosis biliary strictures
Time Frame: 2 Years follow-up
|
Evaluate biliary stricture resolution rate
|
2 Years follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Andrea Tringali, MD, PhD, Fondazione Policlinico Gemelli IRCCS, Rome, Italy
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 12, 2020
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
January 1, 2028
Study Registration Dates
First Submitted
February 25, 2023
First Submitted That Met QC Criteria
March 7, 2023
First Posted (Actual)
March 9, 2023
Study Record Updates
Last Update Posted (Actual)
January 29, 2026
Last Update Submitted That Met QC Criteria
January 27, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathological Conditions, Anatomical
- Digestive System Diseases
- Biliary Tract Diseases
- Bile Duct Diseases
- Constriction, Pathologic
- Cholestasis
- Diagnostic Techniques and Procedures
- Diagnosis
- Surgical Procedures, Operative
- Minimally Invasive Surgical Procedures
- Diagnostic Techniques, Surgical
- Endoscopy, Digestive System
- Diagnostic Techniques, Digestive System
- Endoscopy
- Digestive System Surgical Procedures
- Diagnostic Imaging
- Radiography
- Cholangiography
- Radiography, Abdominal
- Cholangiopancreatography, Endoscopic Retrograde
Other Study ID Numbers
- 2766
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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