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

NCT06767553 | Active Not Recruiting

• 1 other identifier: 2023-11-063
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Failure; Living Donor Liver Transplantation; Biliary Complications; Biliary Stents

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Stented

Patients who received biliary stent placement during liver transplantation.

Non-stented

Patients who did not receive biliary stent placement during liver transplantation.

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chungnam National University Hospital: lead

Study Sites (1)

Chungnam National University Hospital

Daejeon, South Korea

Location

MeSH Terms

Conditions

Liver Failure

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 10, 2025
• Study Start: November 1, 2011
• Primary Completion: October 31, 2024
• Study Completion (Estimated): November 30, 2027
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)