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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Year to 6 Years |
| Sex | All |
| Enrollment | 108 (estimated) |
| Sponsor | Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | February 7, 2023 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | August 11, 2025 |
| Trial ID | NCT06048445 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
- Study coordinator: Weili Wang, MD
- Email: 1519185@zju.edu.cn
- Phone: 19883132292
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.