An observational study in Biliary Atresia, sponsored by Institute of Liver and Biliary Sciences, India. Status unknown at 1 site in India. Open to participants aged Up to 6 Months. Per ClinicalTrials.gov, last updated 2024-06-11.
Sponsored by Institute of Liver and Biliary Sciences, India · Observational
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.
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.
77 studies on the registry are indexed under Biliary Atresia; 25 are open to participants now.
This study's planned enrollment of 100 is below the median of 120 across 33 observational studies indexed under Biliary Atresia.
Browse Biliary Atresia studies →Institute of Liver and Biliary Sciences, India is the lead sponsor of 302 studies on the registry; 87 are open to participants now.
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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).
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Exclusion Criteria:
Subject undergoing Kasai Surgery 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).
Other: Kasai Surgery
As per institute treatment protocol
We expect steroids used in customized manner to improve biliary drainage and thereby improve native liver survival in post kasai patients.
Time frame: Within 6 months
Improved survival with native liver at 12 months of age.
Time frame: 12 months
Reduced progression of portal Hypertension at 6 & 12 months
Time frame: 6 & 12 months
Improved Growth parameters at 3, 6, 12 months
Time frame: 3, 6, 12 months
Reduction in Bilirubin levels at 3, 6, 12 month
Time frame: 3, 6, 12 months
Reduced PELD at 3, 6, 12 months
Time frame: 3, 6, 12 months
Plan to share: Undecided
This study is status unknown, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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