Evaluating a new protocol for treating biliary atresia after surgery
Efficacy of New Post Kasai ILBS Protocol in BiliaryAtresia.
Institute of Liver and Biliary Sciences, India · NCT06447051
This study is testing a new treatment plan for children who have had surgery for biliary atresia to see if it helps their liver function and overall health better than past methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | N/A to 6 Months |
| Sex | All |
| Sponsor | Institute of Liver and Biliary Sciences, India (other) |
| Locations | 1 site (New Delhi, Delhi) |
| Trial ID | NCT06447051 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients who have undergone Kasai surgery for biliary atresia at the Institute of Liver and Biliary Sciences. It includes both a retrospective historical cohort and a prospective cohort to assess the efficacy of a new post-surgery protocol. The study will monitor liver function tests and other health indicators weekly for the first month, then bi-weekly and monthly for up to one year. Statistical analyses will be conducted to evaluate the outcomes of the new protocol compared to historical controls.
Who should consider this trial
Good fit: Ideal candidates are infants and young children diagnosed with biliary atresia who have undergone Kasai surgery at the Institute of Liver and Biliary Sciences.
Not a fit: Patients with major surgical complications or those who do not adhere to the study protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve post-operative outcomes and reduce the need for liver transplantation in children with biliary atresia.
How similar studies have performed: Previous studies have shown some success with corticosteroid therapy in similar contexts, but this specific protocol is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Post Kasai Biliary atresia operated at ILBS with retrospective historical cohort (Jan 2015 to Dec 2017) and retrospective + prospective cohort with new protocol (Jan 2018 till June 2024). Exclusion Criteria: 1. Subjects having major surgical complications 2. Defaulters or Patient not following protocol/not giving consent 3. Biliary atresia splenic malformation
Where this trial is running
New Delhi, Delhi
- Institute of Liver & Biliary Sciences — New Delhi, Delhi, India (RECRUITING)
Study contacts
- Study coordinator: Dr Anmol Anmol, MD
- Email: dranmol1991@gmail.com
- Phone: 01146300000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Biliary Atresia