Clinical trial Recruiting at 1 site Observational Ages 1 Year to 6

Placing a temporary biliary drainage stent during pediatric liver transplant to prevent bile-duct narrowing

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

Run by Zhejiang University · NCT06048445 · Data updated 2026-11-12

This study will try placing a temporary external biliary drainage stent during liver transplant in children up to 6 years old to see if it reduces bile-duct narrowing and related complications.

More Liver Transplant trials

Quick facts

Study typeObservational
Ages1 Year to 6 Years
SexAll
Enrollment108 (estimated)
SponsorZhejiang University
Academic / other
Locations1 site (Hangzhou, Zhejiang)
StatusRecruiting
StartedFebruary 7, 2023
Main results expectedDecember 31, 2026
Study endsDecember 31, 2027
Registry record updatedAugust 11, 2025
Trial IDNCT06048445 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Children aged 6 years or younger undergoing their first liver transplant at the First Affiliated Hospital of Zhejiang University School of Medicine with informed consent from caregivers.

Probably not a fit

Children older than 6, those undergoing repeat liver transplants, patients treated at other centers, and patients with cognitive or mental conditions that affect coordination (an exclusion) would not be eligible and therefore would not directly benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, observational study at the First Affiliated Hospital of Zhejiang University School of Medicine that records outcomes when a biliary external drainage stent is placed during pediatric liver transplantation. The stent is inserted intraoperatively with the intent to lower intrahepatic biliary pressure and reduce postoperative biliary fistula and strictures. Patients are followed after surgery to monitor for biliary stenosis, bile leaks, graft function, and clinical outcomes. The cohort is limited to first-time liver transplant recipients aged 6 years or younger whose caregivers provide informed consent.

Why it matters

Potential benefit: If successful, placing a temporary biliary drainage stent could lower rates of postoperative biliary stenosis and fistula, improving graft survival and quality of life for young transplant recipients.

How similar studies have gone: Clinical practice reports and small case series suggest biliary drainage stents can reduce biliary pressure and may lower leaks or strictures, but robust, large pediatric comparative data are limited.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.