Placing a temporary biliary drainage stent during pediatric liver transplant to prevent bile-duct narrowing
Placement of Biliary Drainage Stent to Prevent Biliary Intestinal Anastomosis After Liver Transplantation in Children: A Prospective Study
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 |
|---|---|
| Enrollment | 108 (estimated) |
| Ages | 1 Year to 6 Years |
| Sex | All |
| Sponsor | Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06048445 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hangzhou, Zhejiang
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.