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

NCT05761483 | Recruiting

• 1 other identifier: 2766
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ischemic Cholangiopathy; Non-anastomotic Biliary Stricture; Biliary Stricture; Biliary Stents (Plastic); Liver Transplant Disorder

Keywords

ERCP; Biliary stents; Liver transplantation; Ischemic cholangiopathy

Outcome Measures

Primary Outcomes (1)

• Evaluation of endoscopic treatment of non-anastomosis biliary strictures

  Evaluate biliary stricture resolution rate

  2 Years follow-up

Interventions

ERCP PROCEDURE

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

Also known as: Biliary stents placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• Previopus endoscopic or percutaneous treatments
• Patient candidate to metal stents placement
• Previous surgery resulting in altered anatomy

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Gemelli IRCCS

Roma, RM, 00168, Italy

RECRUITING

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Andrea Tringali, MD, PhD

  Fondazione Policlinico Gemelli IRCCS, Rome, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Tringali, MD, PD

CONTACT

+393287372601; andrea.tringali@unicatt.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 25, 2023
• First Posted: March 9, 2023
• Study Start: March 12, 2020
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)