Efficacy of New Post Kasai ILBS Protocol in Biliary Atresia.

Biliary Atresia Clinical Trial

Official title: Efficacy of New Post Kasai ILBS Protocol in BiliaryAtresia.

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Biliary Atresia

• NCT number: NCT06447051
• Study type: Observational
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Dr Anmol Anmol, MD
• Phone: 01146300000
• Email: dranmol1991@gmail.com
• Status: Recruiting
• Start date: June 6, 2024
• Completion date: March 31, 2026