RecruitingNCT06048445

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

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


Sponsor

Zhejiang University

Enrollment

108 participants

Start Date

Feb 7, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 1 YearMax Age: 6 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether placing a small drainage tube (stent) in the bile duct during liver transplant surgery can prevent complications with the connection between the bile duct and the intestine in young children. **You may be eligible if...** - Your child had a liver transplant at the First Affiliated Hospital of Zhejiang University School of Medicine - Your child is 6 years old or younger - This is your child's first liver transplant - You are willing to sign a consent form **You may NOT be eligible if...** - Your child has a mental illness that affects their ability to cooperate or follow instructions Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interventions

DEVICEintraoperative plancement of Biliary Drainage Stent

plancement of Biliary Drainage Stent in liver transplantation of pediatric patients


Locations(1)

the First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT06048445


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