Evaluating a new protocol for treating biliary atresia after surgery
Official title: Efficacy of New Post Kasai ILBS Protocol in BiliaryAtresia.
Run by Institute of Liver and Biliary Sciences, India · NCT06447051 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
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 |
|---|---|
| Ages | Any age to 6 Months |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Institute of Liver and Biliary Sciences, India Academic / other |
| Locations | 1 site (New Delhi, Delhi) |
| Trial ID | NCT06447051 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with major surgical complications or those who do not adhere to the study protocol may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown some success with corticosteroid therapy in similar contexts, but this specific protocol is being evaluated for the first time.
Who can join: the full rules
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 it's running
-
Institute of Liver & Biliary Sciences
New Delhi, Delhi, India Recruiting
Study contacts
- Study coordinator: Dr Anmol Anmol, MD
- Email: dranmol1991@gmail.com
- Phone: 01146300000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Umbilical cord stem cells added during Kasai to help biliary atresia
This early-stage trial tests whether injecting umbilical cord mesenchymal stem cells during Kasai portoenterostomy is safe and helpful for infants with biliary atresia.
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See if a computer program can help diagnose cholestasis in newborns using parent-provided stool images
A computer program is being tested to see if it can correctly identify cholestasis and biliary atresia in newborns by analyzing stool images provided by parents.
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Indocyanine green for diagnosing biliary atresia
This test tries to see if a harmless fluorescent dye (indocyanine green) can show whether infants under 3 months with cholestasis have blocked bile ducts (biliary atresia).
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Using near-infrared ICG dye to check bile flow in newborns with cholestasis
We will give eligible newborns a single IV dose of indocyanine green (ICG) to see if the dye appears in their diapers, which would indicate bile is flowing and the bile ducts are open.
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High-MCT nutritional support for infants with biliary atresia
We will test whether giving a high medium-chain triglyceride (MCT) formula before and after Kasai surgery helps infants with biliary atresia grow better and recover faster than standard feeding.
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Using oral antibiotics to prevent cholangitis after liver surgery in infants
This study is testing if giving oral antibiotics to infants after liver surgery can help prevent cholangitis, compared to those who don’t receive the antibiotics.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.