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

NCT ID: NCT06048445

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 108 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-07
• Study Completion Date: 2027-12-31

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.

Conditions

Liver Transplant; Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Biliary Drainage Stent group

placement of Biliary Drainage Stent in pediatric liver transplantation

intraoperative plancement of Biliary Drainage Stent

Intervention Type: DEVICE

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

No interventions assigned to this group

Interventions

intraoperative plancement of Biliary Drainage Stent

plancement of Biliary Drainage Stent in liver transplantation of pediatric patients

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Weili Wang

Deputy Director of the Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Weili Wang, MD

Role: CONTACT

1519185@zju.edu.cn

19883132292 ext. +86

Facility Contacts

Weili Wang, Doctor

Role: primary

Other Identifiers

BDSPBIAP

Identifier Type: -

Identifier Source: org_study_id