Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07328204
Brief Summary:
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.
Study:
NCT07328204
Study Brief:
Protocol Section:
NCT07328204