Comprehensive Efficacy Study of Kasai Portoenterostomy for Biliary Atresia Stratified by Refined Surgical Timing: A Prospective Multicenter Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Native Liver Survival Rate
研究概览
简要总结
What is this study about? This study aims to find out the best timing for a major surgery called Kasai portoenterostomy (Kasai surgery) in infants with a liver disease called biliary atresia. The investigators want to see if having the surgery earlier leads to better long-term health for the baby's own liver.
Why is this important? Doctors know that early surgery is important, but it's unclear exactly how early is best. Some babies have surgery within the first month, others within 2-3 months. The investigators want to carefully compare different time windows to see which one gives the child the best chance to keep their own liver healthy and avoid a liver transplant.
How will the study work?
This is an observational study. The investigators will not change the treatment any child receives. The investigators will enroll about 200 infants from 4-5 children's hospitals in China. The investigators will simply group the infants based on their actual age at surgery:
Group 1: Surgery at 28 days old or younger.
Group 2: Surgery between 29 and 60 days old.
Group 3: Surgery between 61 and 90 days old.
Group 4: Surgery between 91 and 120 days old.
The investigators will then follow all children for 2 years after their surgery.
What will the investigators measure? The main thing the investigators want to see is how many children in each group are alive with their own liver working well 2 years after surgery (without needing a transplant). The investigators will also check many other health factors, like liver function tests, nutrition, growth, complications (like infections), and the costs of care.
What is the goal? The results of this study will help doctors and families make better, evidence-based decisions about the best time to perform this critical surgery for babies with biliary atresia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant age ≤ 120 days at the time of planned surgery.
- •Diagnosis of type III biliary atresia confirmed by clinical presentation, laboratory tests (e.g., conjugated hyperbilirubinemia), and imaging studies (e.g., ultrasonography showing absent or abnormal gallbladder, triangular cord sign).
- •Scheduled to undergo primary (first-time) Kasai portoenterostomy.
- •Legal guardian(s) able to understand and provide written informed consent.
排除标准
- •Presence of other severe congenital malformations that significantly impact prognosis or surgical risk (e.g., complex congenital heart disease requiring intervention, syndromic biliary atresia as part of a polymalformation complex).
- •Pre-existing evidence of decompensated cirrhosis (e.g., refractory ascites, hepatopulmonary syndrome, or hepatic encephalopathy) prior to surgery.
- •Previous history of any liver surgery (including prior Kasai portoenterostomy attempt or liver biopsy via laparotomy).
- •Any condition that, in the opinion of the investigator, would make the infant unsuitable for participation or could interfere with the completion of follow-up (e.g., severe concurrent infection, life-limiting non-hepatic disease).
研究组 & 干预措施
≤28 days
This observational cohort consists of infants diagnosed with type III biliary atresia who receive Kasai portoenterostomy within the first 28 days of life. Group assignment is based solely on the actual age at surgery.
干预措施: Kasai portoenterostomy (Procedure)
29-60 days
This observational cohort consists of infants diagnosed with type III biliary atresia who receive Kasai portoenterostomy between 29 and 60 days of life. This is a naturalistic grouping based on real-world surgical timing.
干预措施: Kasai portoenterostomy (Procedure)
61-90 days
This observational cohort consists of infants diagnosed with type III biliary atresia who receive Kasai portoenterostomy between 61 and 90 days of life. The cohort is defined by the exposure variable (surgical age) for comparative analysis.
干预措施: Kasai portoenterostomy (Procedure)
91-120 days
This observational cohort consists of infants diagnosed with type III biliary atresia who receive Kasai portoenterostomy between 91 and 120 days of life. This group represents the latest surgical timing within the study protocol.
干预措施: Kasai portoenterostomy (Procedure)
结局指标
主要结局
Native Liver Survival Rate
时间窗: 24 months after Kasai surgery
Percentage of participants alive without liver transplantation at 24 months post-operation.
次要结局
- Clearance of Jaundice(At 3 months and 6 months after surgery)
- Incidence of Postoperative Cholangitis(Within 24 months after surgery)
- Incidence of Portal Hypertension(Within 24 months after surgery)
- Longitudinal Change in Liver Enzymes(Preop, 2 weeks, 1, 3, 6, 12, 18, 24 months postop)
- Change in Weight-for-Age Z-score (WAZ)(Preop, 6, 12, 24 months postop)
- Perioperative Complication Rate(Within 30 days after surgery)
研究者
Yijiang Han/Han Yijiang
Attending Physician
The Children's Hospital of Zhejiang University School of Medicine