Incidence & Predictive Factors of Recompensation in Children With Decompensated Cirrhosis as Per the Baveno VII Criteria

NCT ID: NCT06344611

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-07
• Study Completion Date: 2026-03-31

Brief Summary

Cirrhosis is a leading cause of morbidity and mortality world- wide and can develop on the basis of repetitive and/or chronic liver injury due to toxic, infectious, metabolic and genetic pathogenic factors. Traditionally, the natural history of cirrhosis has often been considered a one-way street, with a definite and irreversible progression from a compensated to a decompensated disease stage. But recent data has shown that if the underlying etiology can be successfully treated, cirrhosis can regress and recompensation of liver disease can occur. Hence, in this study we want to evaluate the incidence and predictive factors of recompensation in pediatric subjects with decompensated cirrhosis as per the Baveno VII criteria. We would also evaluate the predictive factors of recompensation in pediatric decompensated chronic liver disase (DCLD) subjects and would explore systemic and intestinal inflammatory markers as possible biomarkers for predicting recompensation in pediatric subjects with decompensated cirrhosis.

Detailed Description

Aim- To evaluate the incidence and predictive factors of recompensation in pediatric subjects with decompensated cirrhosis as per the Baveno VII criteria Primary objective: To determine the incidence of recompensation in pediatric subjects with decompensated cirrhosis as per Baveno VII criteria

Secondary objectives:

1. To evaluate the predictive factors of recompensation in pediatric DCLD subjects

2. To investigate the systemic and intestinal inflammatory markers as possible biomarkers for predicting recompensation in pediatric subjects with decompensated cirrhosis

3. To assess incidence of re-decompensation in patients with recompensation Study design: Prospective, Observational study. Study period:2 years (Aug 2023-Jul2025). Sample size: Time bound; All decompensated cirrhosis cases presenting to the institute during the study period will be included in the study.

Intervention: None, since it is an observational study only

• Monitoring and assessment:
• Along with standard tratment plan/investigatios (as per etiology), Liver function test, INR and Ultrasound abdomen would be done at 3 monthly interval.
• At baseline: Markers of Systemic Inflammation (serum levels of IL-6, TNFα, IL-1β; Monocyte/Basophil Frequency, NLR; CRP, Procalcitonin) and Intestinal Inflammation (Stool cytokines- IL-6, TNFα, IL-1β, IL-10)

Conditions

Decompensated Cirrhosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Decompensated Cirrhosis

Other

Intervention Type: OTHER

It is an observational study. Subjects will receive the treatment as per institute protocol.

Interventions

Other

It is an observational study. Subjects will receive the treatment as per institute protocol.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. < 18 years of age at presentation

2. Decompensated cirrhosis at baseline

1. Cirrhosis:defined asliver histology findings (> F4 fibrosis as per Ishak system), and/or

2. radiological findings of an irregular nodular liver with/out left/caudate liver enlargement

3. Decompensation:defined as presence of ascites (any grade), and/orHE (overt), and/or variceal haemorrhage (endoscopy proven)

3. Fulfilling Recompensation criteria as per Baveno VII (2022) after treatment initiation

4. Sustained cure, suppression or removal of the underlying aetiology of cirrhosis

a. Includes treatable etiologies like Hepatitis B, Autoimmune liver disease, Wilson disease, Budd Chiari syndrome, MLDs (like Galactosemia, Tyrosinemia, Bile acid synthetic defects)

5. Resolution of ascites and hepatic encephalopathy (HE) after discontinuation of diuretics and prophylactic therapies, as well as the absence of variceal bleeding for 12 months.

6. Sustained improvement of biochemical liver function, as as- sessed by serum albumin, bilirubin and INR (international normalized ratio) a. improvement in liver function parameters to values within normal ranges (albumin >35 g/L & INR < 1.5 & bilirubin < 2 mg/dl)

Exclusion Criteria

1. refused consent

2. patients with liver cancer or other active malignancy

3. Any significant extrahepatic disease

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Countries

India

Central Contacts

Dr Anmol Anmol, MD

Role: CONTACT

dranmol1991@gmail.com

01146300000

Dr Vikrant Sood, DM

Role: CONTACT

drvickyster@gmail.com

011-46300000

Facility Contacts

Dr Anmol Anmol, MD

Role: primary

dranmol1991@gmail.com

01146300000

Other Identifiers

ILBS-DCLD-01

Identifier Type: -

Identifier Source: org_study_id