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

• ClinicalTrials.gov Identifier: NCT06048445
• Recruitment Status: Not yet recruiting
• First Posted: September 21, 2023
• Last Update Posted: September 21, 2023
• Sponsor: Zhejiang University
• Information provided by (Responsible Party): Weili Wang, Zhejiang University

Tracking Information

• First Submitted Date: September 9, 2023
• First Posted Date: September 21, 2023
• Last Update Posted Date: September 21, 2023
• Estimated Study Start Date: October 1, 2023
• Estimated Primary Completion Date: December 31, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 15, 2023)

duct-jejunum anastomotic stoma stricture [ Time Frame: one year ]

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 15, 2023)

biliary tract infection [ Time Frame: one year ]

number of participants with biliary tract infection after liver transplantation

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: pediatric patients need liver transplantation
• Condition: Liver Transplant; Complications

Intervention

Device: intraoperative plancement of Biliary Drainage Stent

plancement of Biliary Drainage Stent in liver transplantation of pediatric patients

Study Groups/Cohorts

• Biliary Drainage Stent group
  placement of Biliary Drainage Stent in pediatric liver transplantation
  Intervention: Device: intraoperative plancement of Biliary Drainage Stent
• no Biliary Drainage Stent group
  no placement of Biliary Drainage Stent in pediatric liver transplantation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: September 15, 2023): 108
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2026
• Estimated Primary Completion Date: December 31, 2025 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Year to 6 Years (Child)
• Accepts Healthy Volunteers: No

Contacts

Contact: Weili Wang, MD; 19883132292 ext +86; 1519185@zju.edu.cn

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT06048445
• Other Study ID Numbers: BDSPBIAP
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Weili Wang, Zhejiang University
• Original Responsible Party: Same as current
• Current Study Sponsor: Zhejiang University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Zhejiang University
• Verification Date: September 2023