Biodegradable Stents in Liver Transplant RecipIents for Treatment of Biliary Anastomotic Strictures

Launched by INSTITUTE FOR CLINICAL AND EXPERIMENTAL MEDICINE · Dec 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new type of treatment for patients who have had a liver transplant and are experiencing a common complication known as biliary anastomotic stricture. This condition occurs when there is a narrowing in the bile duct connection, which can lead to complications and discomfort. Currently, the standard treatment involves using special stents, but these require multiple procedures and can sometimes move out of place. The trial is investigating whether biodegradable stents, which are designed to dissolve in the body over time, can effectively treat this condition without the drawbacks of traditional stents.

To participate in this trial, you need to be at least 18 years old, have undergone a liver transplant, and have a specific type of bile duct connection. Participants will be randomly assigned to receive either the biodegradable stents or the standard treatment, and doctors will monitor the effectiveness of both methods in resolving the stricture. The goal is to see if the new stents work just as well as the existing treatments while potentially reducing the need for additional procedures. If you qualify, you’ll be closely followed throughout the study to ensure your safety and track your progress.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years
• • Liver transplant recipients
• • Duct-to-duct biliary anastomosis
• • Anastomotic biliary stricture (cholestasis unexplained by other causes and/or liver biopsy showing altered biliary drainage and/or anastomotic stricture on MRCP)
• • Signed informed consent
• Exclusion Criteria:
• • Hepaticojejunoanastomosis
• • Physical and/or psychological inability to understand the aims of the research and to adequately cooperate
• • Pregnancy