Placement of Biliary Drainage Stent to Prevent Biliary Intestinal Anastomosis After Liver Transplantation in Children

Sponsor
Zhejiang University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06048445
Collaborator
(none)
108
39

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: intraoperative plancement of Biliary Drainage Stent

Study Design

Study Type:
Observational
Anticipated Enrollment :
108 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Placement of Biliary Drainage Stent to Prevent Biliary Intestinal Anastomosis After Liver Transplantation in Children: A Prospective Study
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Biliary Drainage Stent group

placement of Biliary Drainage Stent in pediatric liver transplantation

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

no Biliary Drainage Stent group

no placement of Biliary Drainage Stent in pediatric liver transplantation

Outcome Measures

Primary Outcome Measures

  1. duct-jejunum anastomotic stoma stricture [one year]

    number of participants with duct-jejunum anastomotic stoma stricture after liver transplantation

Secondary Outcome Measures

  1. biliary tract infection [one year]

    number of participants with biliary tract infection after liver transplantation

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Weili Wang, Deputy Director of the Department, Zhejiang University
ClinicalTrials.gov Identifier:
NCT06048445
Other Study ID Numbers:
  • BDSPBIAP
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 21, 2023