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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06447051
• Other study ID #: ILBS-Biliary Atresia-01
• Status: Recruiting
• Start date: June 6, 2024
• Est. completion date: March 31, 2026

Study information

• Verified date: March 2024
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Dr Anmol Anmol, MD
• Phone: 01146300000
• Email: dranmol1991[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

1. 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).

Exclusion Criteria:

1. Subjects having major surgical complications

2. Defaulters or Patient not following protocol/not giving consent

3. Biliary atresia splenic malformation

Related Conditions & MeSH terms

• Biliary Atresia

Intervention

Other:
• Kasai Surgery
As per institute treatment protocol

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	We expect steroids used in customized manner to improve biliary drainage and thereby improve native liver survival in post kasai patients.		Within 6 months
Secondary	Improved survival with native liver at 12 months of age.		12 months
Secondary	Reduced progression of portal Hypertension at 6 & 12 months		6 & 12 months
Secondary	Improved Growth parameters at 3, 6, 12 months		3, 6, 12 months
Secondary	Reduction in Bilirubin levels at 3, 6, 12 month		3, 6, 12 months
Secondary	Reduced PELD at 3, 6, 12 months		3, 6, 12 months