Efficacy of New Post Kasai ILBS Protocol in Biliary Atresia.

NCT06447051 | Recruiting

• 1 other identifier: ILBS-Biliary Atresia-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Biliary Atresia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

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

Interventions

Kasai Surgery OTHER

As per institute treatment protocol

Biliary Atresia

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• 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).

You may not qualify if:

• Subjects having major surgical complications
• Defaulters or Patient not following protocol/not giving consent
• Biliary atresia splenic malformation

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Biliary Atresia

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Dr Anmol Anmol, MD

CONTACT

01146300000; dranmol1991@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 6, 2024
• Study Start: June 6, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: June 11, 2024

Record last verified: 2024-03

Locations

IN (1)