NCT06048445 Placement of Biliary Drainage Stent to Prevent Biliary Intestinal Anastomosis After Liver Transplantation in Children
| NCT ID | NCT06048445 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhejiang University |
| Condition | Liver Transplant; Complications |
| Study Type | OBSERVATIONAL |
| Enrollment | 108 participants |
| Start Date | 2023-02-07 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 108 participants in total. It began in 2023-02-07 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06048445 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 6 Years, studying Liver Transplant; Complications. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06048445 currently recruiting?
Yes, NCT06048445 is actively recruiting participants. Contact the research team at 1519185@zju.edu.cn for enrollment information.
Where is the NCT06048445 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06048445 clinical trial?
NCT06048445 is sponsored by Zhejiang University. The trial plans to enroll 108 participants.