Efficacy of New Post Kasai ILBS Protocol in BiliaryAtresia.

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 6 months
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
India
Institute of Liver & Biliary Sciences
RECRUITING
New Delhi
Contact Information
Primary
Dr Anmol Anmol, MD
dranmol1991@gmail.com
01146300000
Time Frame
Start Date: 2024-06-06
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 100
Treatments
Biliary Atresia
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).
Related Therapeutic Areas
Sponsors
Leads: Institute of Liver and Biliary Sciences, India

This content was sourced from clinicaltrials.gov