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

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05761483
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Anticipated Duration (Months): 81.7
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Liver Transplant Disorder; Ischemic Cholangiopathy; Non-anastomotic Biliary Stricture; Biliary Stricture; Biliary Stents (Plastic)	Procedure: ERCP

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Endoscopic Management of Non-anastomotic Biliary Strictures Following Liver Transplantation. Registry of the Italian Society of Digestive Endoscopy.
• Actual Study Start Date: Mar 12, 2020
• Actual Primary Completion Date: Feb 22, 2023
• Anticipated Study Completion Date: Jan 1, 2027

Outcome Measures

Primary Outcome Measures

1. Evaluation of endoscopic treatment of non-anastomosis biliary strictures [2 Years follow-up]

   Evaluate biliary stricture resolution rate

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Policlinico Gemelli IRCCS	Roma	RM	Italy	00168

Sponsors and Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tringali Andrea, MD, PhD, Assistant Professor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• ClinicalTrials.gov Identifier: NCT05761483
• Other Study ID Numbers: 2766
• First Posted: Mar 9, 2023
• Last Update Posted: Mar 9, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Tringali Andrea, MD, PhD, Assistant Professor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS: ERCP; Biliary stents; Liver transplantation; Ischemic cholangiopathy
• Additional relevant MeSH terms: Cholestasis; Constriction, Pathologic

Study Results

No Results Posted as of Mar 9, 2023