Intraductal Transanastomotic Stent in Duct-to-duct Biliary Reconstruction in Liver Transplantation
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04804215 |
Recruitment Status :
Enrolling by invitation
First Posted : March 18, 2021
Last Update Posted : January 30, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Liver Transplant; Complications | Procedure: Intraductal transanastomotic stent group Procedure: No stent group | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 276 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Intraductal Transanastomotic Stent in Duct-to-duct Biliary Reconstruction in Liver Transplantation: Multicenter, Randomized Controlled Trial |
Actual Study Start Date : | November 25, 2022 |
Estimated Primary Completion Date : | November 30, 2024 |
Estimated Study Completion Date : | December 30, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: The experimental group in Intraductal transanastomotic stent
Inclusion criteria
Intraductal transanastomotic stent was used during biliary reconstruction |
Procedure: Intraductal transanastomotic stent group
When bile duct anastomosis is performed, a intraductal transanastomotic stent is inserted into the bile duct. |
Experimental: The controled group in non-Intraductal transanastomotic stent
Inclusion criteria
No stent was used during biliary reconstruction |
Procedure: No stent group
Do not insert a stent into the bile duct during anastomosis of the bile duct. |
- 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
- Postoperative complications rate (%) related to intrabiliary stents [ Time Frame: 6 months ]Postoperative complications rate (%) related to intrabiliary stents (cholangitis, acute pancreatitis, intestinal perforation, bleeding, etc.), liver transplantation
- 6-month survival rate [ Time Frame: 6 months ]6-month survival rate (%)
- hospitalization period [ Time Frame: 21days ]length of hospital stay (days)
- re-hospitalization rate [ Time Frame: 6 months ]re-hospitalization rate (%)
- non-biliary complications rate [ Time Frame: 6 months ]non-biliary complications rate (%) such as atelectasis, pneumonia, wound infection, sepsis, septic shock, etc.
- Clinical effectiveness of biliary stent use [ Time Frame: 6 months ]the need for additional procedures rate (%) such as endoscopic intervention or angiography
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 19 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-
19 years old or older ~ under 70 years old
- Patients eligible for liver transplantation ③ Patients who have consented to written consent
Exclusion Criteria:
① When performing hepato-plant anastomosis due to anatomical/biliary tract disease
② Patients who are not eligible for liver transplantation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04804215
Korea, Republic of | |
Department of HBP Surgery, Seoul St. Mary's hospital | |
Seoul, Seocho-gu, Banopo-dong, Korea, Republic of, 137-701 |
Study Director: | 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 |
Responsible Party: | Ho Joong Choi, Professor, Seoul St. Mary's Hospital |
ClinicalTrials.gov Identifier: | NCT04804215 |
Other Study ID Numbers: |
Liver-01 |
First Posted: | March 18, 2021 Key Record Dates |
Last Update Posted: | January 30, 2023 |
Last Verified: | January 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
biliary reconstruction Intraductal transanastomotic stent |