Intraductal Transanastomotic Stent in Duct-to-duct Biliary Reconstruction in Liver Transplantation
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ClinicalTrials.gov Identifier: NCT04804215 |
Recruitment Status :
Enrolling by invitation
First Posted : March 18, 2021
Last Update Posted : January 30, 2023
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Tracking Information | ||||||||||
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First Submitted Date ICMJE | March 7, 2021 | |||||||||
First Posted Date ICMJE | March 18, 2021 | |||||||||
Last Update Posted Date | January 30, 2023 | |||||||||
Actual Study Start Date ICMJE | November 25, 2022 | |||||||||
Estimated Primary Completion Date | November 30, 2024 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures ICMJE |
The incidence of biliary tract complications within 6 months after surgery [ Time Frame: 6 months ] 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
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Original Primary Outcome Measures ICMJE | Same as current | |||||||||
Change History | ||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
Descriptive Information | ||||||||||
Brief Title ICMJE | Intraductal Transanastomotic Stent in Duct-to-duct Biliary Reconstruction in Liver Transplantation | |||||||||
Official Title ICMJE | Intraductal Transanastomotic Stent in Duct-to-duct Biliary Reconstruction in Liver Transplantation: Multicenter, Randomized Controlled Trial | |||||||||
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. |
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Detailed Description | Aim of study
Subject selection criteria, exclusion criteria, number of target subjects and their rationale
Study design
Criteria for end of study and early termination
Study method
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Study Type ICMJE | Interventional | |||||||||
Study Phase ICMJE | Not Applicable | |||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Liver Transplant; Complications | |||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||
Recruitment Status ICMJE | Enrolling by invitation | |||||||||
Estimated Enrollment ICMJE |
276 | |||||||||
Original Estimated Enrollment ICMJE |
160 | |||||||||
Estimated Study Completion Date ICMJE | December 30, 2024 | |||||||||
Estimated Primary Completion Date | November 30, 2024 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: ① When performing hepato-plant anastomosis due to anatomical/biliary tract disease ② Patients who are not eligible for liver transplantation |
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Sex/Gender ICMJE |
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Ages ICMJE | 19 Years to 70 Years (Adult, Older Adult) | |||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
Listed Location Countries ICMJE | Korea, Republic of | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT04804215 | |||||||||
Other Study ID Numbers ICMJE | Liver-01 | |||||||||
Has Data Monitoring Committee | Not Provided | |||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Ho Joong Choi, Seoul St. Mary's Hospital | |||||||||
Original Responsible Party | Same as current | |||||||||
Current Study Sponsor ICMJE | Seoul St. Mary's Hospital | |||||||||
Original Study Sponsor ICMJE | Same as current | |||||||||
Collaborators ICMJE | Not Provided | |||||||||
Investigators ICMJE |
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PRS Account | Seoul St. Mary's Hospital | |||||||||
Verification Date | January 2023 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |