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

NCT06048445 | Recruiting

• 1 other identifier: BDSPBIAP
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• duct-jejunum anastomotic stoma stricture

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

  one year

Secondary Outcomes (1)

• biliary tract infection

  one year

Study Arms (2)

Biliary Drainage Stent group

placement of Biliary Drainage Stent in pediatric liver transplantation

Device: intraoperative plancement of Biliary Drainage Stent

no Biliary Drainage Stent group

no placement of Biliary Drainage Stent in pediatric liver transplantation

Interventions

intraoperative plancement of Biliary Drainage Stent DEVICE

plancement of Biliary Drainage Stent in liver transplantation of pediatric patients

Biliary Drainage Stent group

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

pediatric patients need liver transplantation

You may qualify if:

• The patient underwent liver transplantation surgery at the First Affiliated Hospital of Zhejiang University School of Medicine;
• Age ≤ 6 years old;
• First liver transplantation;
• Willing to sign an informed consent form.

You may not qualify if:

• \- Existence of mental illnesses that can affect cognition and coordination.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

the First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

Central Study Contacts

Weili Wang, MD

CONTACT

19883132292; 1519185@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the Department

Study Record Dates

• First Submitted: September 9, 2023
• First Posted: September 21, 2023
• Study Start: February 7, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

CN (1)