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Clinical Trials in China / NCT06048445
Recruiting Observational

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

NCT06048445 · tracked via the Priya Life Science China tracker
Sponsor
Zhejiang University
Phase
Observational
Started
2023-02-07
Last updated
2025-08-11

Condition(s) studied

Liver Transplant; Complications

Investigational drug(s) / intervention(s)

intraoperative plancement of Biliary Drainage Stent

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

Study 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.

Eligibility

Sex
ALL
Min age
1 Year
Max age
6 Years
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
the First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06048445 on ClinicalTrials.gov ↗ ← All trials in China