Intraductal Transanastomotic Stent in Duct-to-duct Biliary Reconstruction in Liver Transplantation

Summary

Liver transplant surgery has been used as a major treatment modality for end-stage liver disease, hepatocellular carcinoma and acute liver failure due to innovations in surgical treatment of donors and recipients over the past decade. However, despite these advances, biliary tract complications are considered the technical "Achilles tendon" of liver transplantation because of their high incidence, long-term interventions and potential risk of transplant failure. The incidence of biliary tract complications after liver transplantation is still a high incidence, with a prevalence of 10-50% despite increasing technology and experience worldwide. Biliary tract complications are typically biliary tract leakage and biliary stricture, which are the cause of post-transplant morbidity and transplant loss. Most of the bile leakage occurs within 3 months after surgery, and the incidence of these early complications reaches 10-20%. Biliary stricture is a late complication that usually occurs within 5-8 months and can occur up to 1 year. The incidence of biliary stricture currently reported is still occurring in 5-30% of large clinical studies.

The use of external T-tubes to reduce biliary tract complications has been discussed for many years, and many published studies show no difference in biliary tract complications regardless of the use of T-tubes, as well as T-tube-related cholangitis and tube removal. Showed a relationship with certain morbidity rates, such as bile leakage.

Insertion of a stent into the bile duct has the advantage of preventing biliary complications while avoiding the side effects associated with the use of external T-tubes. We presented a preliminary study of 100 patients and confirmed that intrabiliary stents reduced biliary tract complications, and not using an intrabiliary stent was an independent risk factor for biliary stenosis.

Therefore, in this study, the purpose of this study was to determine the effective and rational use of intrabiliary stents through a randomized clinical trial according to the use of intrabiliary stents during biliary reconstruction in patients with liver transplant surgery. In addition, it is expected that clinical usefulness has not been announced until now in Korea, since a double-blind prospective randomized controlled clinical trial was conducted according to the presence or absence of an intrabiliary stent during biliary reconstruction in liver transplantation.

Conditions

• Liver Transplant; Complications

Interventions

PROCEDURE

Intraductal transanastomotic stent group

When bile duct anastomosis is performed, a intraductal transanastomotic stent is inserted into the bile duct.

PROCEDURE

No stent group

Do not insert a stent into the bile duct during anastomosis of the bile duct.

Sponsors & Collaborators

• Seoul St. Mary's Hospital

  lead OTHER

Principal Investigators

• Yoonkyung Woo, MD · Seoul St. Mary's Hospital

• Yoonyung Choi, MD · Seoul St. Mary's Hospital

• Jin Ha Chun, MD · Seoul St. Mary's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-11-25

Primary Completion

2024-11-30

Completion

2024-12-30

Countries

• South Korea

Study Locations