Efficacy of New Post Kasai ILBS Protocol in Biliary Atresia.

Efficacy of New Post Kasai ILBS Protocol in BiliaryAtresia.

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 Overview

• Status: Recruiting
• Conditions: Biliary Atresia
• Intervention / Treatment: Other: Kasai Surgery

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Dr Anmol Anmol, MD; Phone Number: 01146300000; Email: dranmol1991@gmail.com

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Recruiting
      • Institute of Liver & Biliary Sciences
      • Contact: Dr Anmol, MD; Phone Number: 01146300000; Email: dranmol1991@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Other: Kasai Surgery; As per institute treatment protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Improved survival with native liver at 12 months of age.	12 months
Reduced progression of portal Hypertension at 6 & 12 months	6 & 12 months
Improved Growth parameters at 3, 6, 12 months	3, 6, 12 months
Reduction in Bilirubin levels at 3, 6, 12 month	3, 6, 12 months
Reduced PELD at 3, 6, 12 months	3, 6, 12 months

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2024
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: June 3, 2024
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Congenital Abnormalities; Biliary Tract Diseases; Bile Duct Diseases; Digestive System Abnormalities; Biliary Atresia
• Other Study ID Numbers: ILBS-Biliary Atresia-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No