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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06048445
Recruitment Status : Not yet recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
Weili Wang, Zhejiang University

Study Description
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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.


Condition or disease Intervention/treatment
Liver Transplant; Complications Device: intraoperative plancement of Biliary Drainage Stent

Study Design
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Study Type : Observational
Estimated Enrollment : 108 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Placement of Biliary Drainage Stent to Prevent Biliary Intestinal Anastomosis After Liver Transplantation in Children: A Prospective Study
Estimated Study Start Date : October 1, 2023
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Biliary Drainage Stent group
placement of Biliary Drainage Stent in pediatric liver transplantation
 Device: intraoperative plancement of Biliary Drainage Stent
plancement of Biliary Drainage Stent in liver transplantation of pediatric patients
no Biliary Drainage Stent group
no placement of Biliary Drainage Stent in pediatric liver transplantation


Outcome Measures
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Primary Outcome Measures :
  1. duct-jejunum anastomotic stoma stricture [ Time Frame: one year ]
    number of participants with duct-jejunum anastomotic stoma stricture after liver transplantation


Secondary Outcome Measures :
  1. biliary tract infection [ Time Frame: one year ]
    number of participants with biliary tract infection after liver transplantation


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
pediatric patients need liver transplantation
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06048445


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

Sponsors and Collaborators
Zhejiang University
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Weili Wang, Deputy Director of the Department, Zhejiang University
ClinicalTrials.gov Identifier: NCT06048445    
Other Study ID Numbers: BDSPBIAP
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023

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