Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447051
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-06-03
Brief Title:
Efficacy of New Post Kasai ILBS Protocol in Biliary Atresia
Sponsor:
Institute of Liver and Biliary Sciences India
Organization:
Institute of Liver and Biliary Sciences India
Study Overview
Official Title:
Efficacy of New Post Kasai ILBS Protocol in BiliaryAtresia
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 mgdL 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 34 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None