Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06048445
Other study ID # BDSPBIAP
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 1, 2023
Est. completion date December 31, 2026

Study information

Verified date September 2023
Source Zhejiang University
Contact Weili Wang, MD
Phone 19883132292
Email 1519185@zju.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Liver transplantation is an effective method for treating end-stage liver disease and metabolic diseases in children. With the advancement of surgical techniques and the improvement of perioperative management, the survival rates of patients and grafts after liver transplantation have significantly improved. However, the complication of biliary stenosis after transplantation is as high as 7.3% -33.3%, and in severe cases, it can even lead to graft failure and patient death. Therefore, the occurrence of biliary stenosis after liver transplantation seriously affects the quality of life of children, increases the economic burden on families, and urgently needs to find effective methods to reduce the occurrence of this complication. Based on the clinical practice of our center, we believe that the placement of biliary external drainage stents has the following advantages: 1 Reduce intrahepatic biliary pressure and reduce the occurrence of postoperative biliary fistula; 2. The stent has a supporting effect and can maintain the open state of the bile duct; 3. By external drainage, the quality of bile secretion by the liver can be evaluated; 4. Provide a pathway for cholangiography. However, placing external biliary drainage may also pose certain risks, including increasing surgical procedures, stent detachment causing biliary fistula, and increasing the risk of infection. This study aims to observe the effect of placing external biliary drainage stents on biliary stricture after liver transplantation in children. The aim is to evaluate the preventive effect of external biliary drainage stents on biliary intestinal anastomotic stenosis after liver transplantation in children, and to provide evidence-based evidence for reducing biliary complications in children.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 108
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 1 Year to 6 Years
Eligibility Inclusion Criteria: 1. The patient underwent liver transplantation surgery at the First Affiliated Hospital of Zhejiang University School of Medicine; 2. Age = 6 years old; 3. First liver transplantation; 4. Willing to sign an informed consent form. Exclusion Criteria: - Existence of mental illnesses that can affect cognition and coordination.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
intraoperative plancement of Biliary Drainage Stent
plancement of Biliary Drainage Stent in liver transplantation of pediatric patients

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Zhejiang University

Outcome

Type Measure Description Time frame Safety issue
Primary duct-jejunum anastomotic stoma stricture number of participants with duct-jejunum anastomotic stoma stricture after liver transplantation one year
Secondary biliary tract infection number of participants with biliary tract infection after liver transplantation one year
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05818644 - Hepatic Artery Stenosis and Thrombosis After Liver Transplantation in Children
Not yet recruiting NCT06041490 - Adjuvant Therapy for High-risk Hepatocellular Carcinoma Post Liver Transplantation Phase 2
Recruiting NCT04443322 - Durvalumab and Lenvatinib in Participants With Locally Advanced and Metastatic Hepatocellular Carcinoma ( Dulect2020-1 ) N/A
Recruiting NCT05081141 - HHV8 and Solid Organ Transplantation
Completed NCT03165916 - Study to Compare the Incidence of Biliary Complications After Liver Transplantation N/A
Withdrawn NCT04216303 - Optimal A1c Control in Post Liver or Combined Liver and Kidney Transplant Recipients Who Have Diabetes Mellitus
Recruiting NCT04506398 - Heterogeneity and Evolution of hepatoceLlular Carcinoma in Post-transplant HCC Recurrence
Not yet recruiting NCT05853484 - Home-based Bimodal Lifestyle Intervention in Patients With Liver Cirrhosis Awaiting Orthotopic Liver Transplantation N/A
Not yet recruiting NCT05036031 - Transplantation for EASL-CLIF and APASL ACLF Patients: a Retrospective Cohort Study
Recruiting NCT05065125 - Clinical Usefulness of Digital Single-operator Cholangioscopy(SpyGlass™) for Post-liver Transplant Anastomotic Stricture
Recruiting NCT06060392 - Effect of Oral Semaglutide on Liver Fat and Body Composition in Liver Transplant Recipients With Diabetes Mellitus N/A
Enrolling by invitation NCT05195944 - Semaglutide vs Sitagliptin Phase 4
Completed NCT05255510 - Risk of Acute Kidney Injury in Living Liver Donor Surgery
Completed NCT05116748 - COVID19 Vaccine in SOT Adult Recipients
Completed NCT04182256 - Magnetic Spiderman for Preparation of Liver Donation N/A
Recruiting NCT04327427 - Outcome Analysis of Aspirin in Liver Transplantation
Recruiting NCT04477967 - Design and Implementation of the Pediatric Liver Transplantation Biobank
Recruiting NCT05109156 - Preoperative Sepsis Timeline, Profile and Its Association With Recipient Outcome Following Live Donor Liver Transplant
Recruiting NCT06124209 - Use of Fibrin Sealant Patch for Vein Anastomosis During Deceased Donor Liver Transplantation- Randomized Clinical Trial Phase 4
Recruiting NCT04054999 - Methylene Blue vs Cyanokit for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients Phase 4