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

NCT04804215 | Unknown

• 1 other identifier: Liver-01
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

biliary reconstruction; Intraductal transanastomotic stent

Outcome Measures

Primary Outcomes (1)

• The incidence of biliary tract complications within 6 months after surgery

  The incidence of biliary tract complications within 6 months after surgery according to the presence or absence of an intrabiliary stent during biliary reconstruction in liver transplantation

  6 months

Secondary Outcomes (6)

• Postoperative complications rate (%) related to intrabiliary stents

  6 months

• 6-month survival rate

  6 months

• hospitalization period

  21days

• re-hospitalization rate

  6 months

• non-biliary complications rate

  6 months

Study Arms (2)

The experimental group in Intraductal transanastomotic stent

EXPERIMENTAL

Inclusion criteria * 19 years old or older \~ under 70 years old * Patients eligible for liver transplantation ③ Patients who have consented to written consent Intraductal transanastomotic stent was used during biliary reconstruction

Procedure: Intraductal transanastomotic stent group

The controled group in non-Intraductal transanastomotic stent

EXPERIMENTAL

Inclusion criteria * 19 years old or older \~ under 70 years old * Patients eligible for liver transplantation ③ Patients who have consented to written consent No stent was used during biliary reconstruction

Procedure: No stent group

Interventions

Intraductal transanastomotic stent group PROCEDURE

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

The experimental group in Intraductal transanastomotic stent

No stent group PROCEDURE

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

The controled group in non-Intraductal transanastomotic stent

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older \~ under 70 years old
• Patients eligible for liver transplantation ③ Patients who have consented to written consent

You may not qualify if:

• ① When performing hepato-plant anastomosis due to anatomical/biliary tract disease
• ② Patients who are not eligible for liver transplantation

Sponsors & Collaborators

• Seoul St. Mary's Hospital: lead

Study Sites (1)

Department of HBP Surgery, Seoul St. Mary's hospital

Seoul, Seocho-gu, Banopo-dong, 137-701, South Korea

Location

Study Officials

• Yoonkyung Woo, MD

  Seoul St. Mary's Hospital

  STUDY DIRECTOR

• Yoonyung Choi, MD

  Seoul St. Mary's Hospital

  STUDY DIRECTOR

• Jin Ha Chun, MD

  Seoul St. Mary's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 7, 2021
• First Posted: March 18, 2021
• Study Start: November 25, 2022
• Primary Completion: November 30, 2024
• Study Completion: December 30, 2024
• Last Updated: January 30, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)