Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07328204
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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).
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT07328204
Study Brief:
Protocol Section:
NCT07328204