NCT06447051

Efficacy of New Post Kasai ILBS Protocol in Biliary Atresia.

Efficacy of New Post Kasai ILBS Protocol in BiliaryAtresia.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

Summary

Biliary atresia (BA) is a neonatal progressive fibrosing cholan- giopathy and the most frequent indication for pediatric liver trans- plantation \[1\]. Surgical removal of biliary remnants and Roux-en-Y hepatoportoenterostomy (HPE) aims to restore biliary drainage and suppress progression to cirrhosis. Successful HPE, defined as a serum total bilirubin level \<2 mg/dL at three months after surgery, occurs in ∼50% of patients in the United States \[2\]. Young age seems to be the best predictor of response to HPE, with limited data on the efficacy of adjuvant therapies such as corticosteroids, antibiotics, and choleretic agents \[3,4\]. Potential modes of action of these therapies are to increase bile flow as well as exert an anti- inflammatory effect \[5\]. In 2007, a double-blind randomized trial in the United Kingdom identified a beneficial effect on corticosteroid therapy on reduction of bilirubin level at one month post HPE without sig- nificant change in the need for liver transplantation \[6\]. Since then there have been multiple trial most prominent being, Kings hospital trial \[7\] and START trial \[8\] which demonstrated reduction in bilirubin levels; however both failed to demonstrate any effect on native liver survival. However one study done by Bezerra et al \[9\] where they employed steroid in customised manner showed significant improvement in bile drainage in their subjects versus their historical cohort. Hence we propose to perform a prospective cohort study to assess the Efficacy of new post Kasai (steroid) ILBS protocol in Biliary Atresia.

Detailed description

Study population : Subject undergoing Kasai Sx at Institute of Liver and Biliary Sciences would be enrolled and will include retrospective historical cohort (Jan 2015 to Dec 2017) and retrospective + prospective cohort with new protocol (Jan 2018 till June 2024). Study design: Cohort study with historical control ( Jan 2015- Dec 2017) Sample size: Time bound. All cases presenting during the study period will be included in the study. Monitoring and assessment: Liver function test, Hemogram and International Normalised Ratio (INR) would be done weekly for one month, twice weekly for 2nd month and monthly thereafter till 1 year. Statistical Analysis: Appropriate statistical test for correlation analysis will be applied. Adverse effects: As per previous studies done , no serious adverse effect has been noted in treatment group vs control group.

Conditions

• Biliary Atresia

Interventions

Type	Name	Description
OTHER	Kasai Surgery	As per institute treatment protocol

Timeline

• Start date: 2024-06-06
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2024-06-06
• Last updated: 2024-06-11

Locations

1 site across 1 country: India