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NCT Number: NCT06767553

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Liver Failure Biliary Complications Biliary Stents Digestive System Diseases Hepatic Insufficiency Liver Diseases Living Donor Liver Transplantation

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chungnam National University Hospital

Daejeon, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence of Biliary Complications

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chungnam National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2024
Study completion
2027
First posted
Jan 10, 2025
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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