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

Impact of Non-stenting Method with Mucosal Eversion on Biliary Complications Post-LDLT in a Mid-volume Center: a Propensity Score-Matching Analysis of Case-Control Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Liver Failure; Biliary Complications; Living Donor Liver Transplantation; Biliary Stents

• Study Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of
    • Chungnam National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study includes adult patients aged 19 to 80 years who underwent liver transplantation for liver disease at Chungnam National University Hospital. The study population consists of patients who received either biliary stent placement or no stent placement during the liver transplantation surgery. Data will be retrospectively reviewed to compare biliary complications between the two groups.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Stented; Patients who received biliary stent placement during liver transplantation.
Non-stented; Patients who did not receive biliary stent placement during liver transplantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Biliary Complications	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.	Within 10 years after liver transplantation

Collaborators and Investigators

• Sponsor: Chungnam National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2011
• Primary Completion (Actual): October 31, 2024
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: January 8, 2025
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Hepatic Insufficiency; Liver Failure
• Other Study ID Numbers: 2023-11-063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will not be shared publicly due to the retrospective nature of the study and privacy protection concerns.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No