Biliary Complication Rates in Living Donor Liver Transplantation: a Retrospective Comparative Study of Stent Versus Non-Stent Groups

Active, not recruiting

• Conditions: Liver Failure; Living Donor Liver Transplantation; Biliary Complications; Biliary Stents

• Registration Number: NCT06767553
• Lead Sponsor: Chungnam National University Hospital

Brief Summary

Despite technological advancements in living donor liver transplantation (LDLT), biliary complications (BC), including biliary anastomotic stricture (BAS) and bile leak (BL), remain unresolved issues that significantly affect patient outcomes. Biliary stenting has emerged as a potential method for reducing BC in LDLT procedures; however, their necessity remains debated. This study aimed to assess the necessity of biliary stenting by retrospectively comparing the bile duct complication rates in LDLT using duct-to-duct anastomosis with or without biliary stenting.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-01
• Primary Completion: 2024-10-31
• Status Verified: 2025-01
• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Study First Posted: 2025-01-10
• Last Update Posted: 2025-01-10
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Adults aged between 19 and 80 years at the time of liver transplantation.
• Patients who underwent liver transplantation surgery for liver disease performed by the Department of Surgery at Chungnam National University Hospital under the supervision of the principal investigator.
• Patients who signed the informed consent form before study registration (for future participants).

Exclusion Criteria

• Patients who have not signed the informed consent form or have insufficient understanding of the clinical trial protocol, making it difficult to accurately express their intention to participate.
• Patients deemed unsuitable for participation in this clinical study by the investigator.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Biliary Complications	Within 10 years after liver transplantation	The primary outcome measure is the incidence of biliary complications, including bile leaks and biliary anastomotic strictures, within 10 years post-liver transplantation. Measurment is done by electronic medical record review of post-operative imaging and clinical diagnosis during follow up period.

Trial Locations

Locations (1)

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of