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:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-24 @ 7:18 PM
NCT ID:
NCT04260503
Eligibility Criteria:
1. Biliary atresia (Disease)
Inclusion Criteria:
* 0-4 months old
* Patients, diagnosed with the BA and scheduled for Kasai operation during our study period
* Patients whose parents or guardian understand our research aims, and comply to participate in our researches
Exclusion Criteria:
* Patients, whose diagnosis of BA was not definite.
* Patients, scheduled for Kasai operation after 4 months old
2. Choledochal cyst (Disease control)
Inclusion Criteria:
* 0-7 years old
* Patients, diagnosed with choledochal cyst and scheduled for total cyst removal during our study period
* Patients whose parents or guardian understand our research aims, and comply to participate in our researches
Exclusion Criteria:
* Patients, whose diagnosis of choledochal cysts was not definite.
* Patients with choledochal cyst, but greater than 7 years old
3. Neonatal hepatitis (Disease control)
Inclusion Criteria:
* 0-4 months old
* Patients, diagnosed with the neonatal hepatitis during our study period
* Patients whose parents or guardian understand our research aims, and comply to participate in our researches
Exclusion Criteria:
* Patients with hepatobiliary infection
* Patients, required to use antibiotics to treat the infection
* Patients with hepatobiliary inflammation, caused by abnormal intra- or extra-hepatic structure
4. Healthy control
Inclusion Criteria:
* 0-4 months old
* Healthy neonates without chronic diseases when they visit for vaccination
* Healthy neonates whose parents or guardian understand our research aims, and comply to participate in our researches
Exclusion Criteria:
* Patients with hepatobiliary infection
* Patients, required to use antibiotics to treat the infection
* Neonates with less than 37 weeks (i.e., preterm) or hospitalized in neonatal intensive care unit
* Patients, diagnosed with congenital malformation, syndrome and chronic diseases
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
7 Years
Study:
NCT04260503
Study Brief:
Protocol Section:
NCT04260503