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NCT Number: NCT06048445

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

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.

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Key information

Age range

1 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location status: Recruiting

Location contact

Weili Wang, Doctor

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

intraoperative plancement of Biliary Drainage Stent

Device

plancement of Biliary Drainage Stent in liver transplantation of pediatric patients

Primary outcomes

  1. duct-jejunum anastomotic stoma stricture

    Time frame: one year

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

Secondary outcomes

  1. biliary tract infection

    Time frame: one year

    number of participants with biliary tract infection after liver transplantation

Study contacts

Contact information is provided by the study sponsor or research team.

Weili Wang, MD

CONTACT

[email protected]

19883132292 ext. +86

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

Placement of Biliary Drainage Stent to Prevent Biliary Intestinal Anastomosis After Liver Transplantation in Children: A Prospective Study

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Sep 21, 2023
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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