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CTRI Number  CTRI/2026/02/103633 [Registered on: 11/02/2026] Trial Registered Prospectively
Last Modified On: 11/02/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Ultrasound-Based Assessment of Poor Muscle Mass in Children with Chronic Liver Disease 
Scientific Title of Study   Ultrasound-Based Sarcopenia Assessment in Pediatric Chronic Liver Disease: Correlation with Clinical Outcomes and Evaluation of a PELD-Sarcopenia Scoring Model 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tryambak Samanta 
Designation  Associate Profesor, Department of Medical Gastroenterology, Medical College, Kolkata 
Affiliation  Medical College, Kolkata 
Address  Room No 5006, 5th Floor, Super Speciality Building (department of Medical Gastroenterology) Medical College, 88, College Street, Medical College

Kolkata
WEST BENGAL
700073
India 
Phone  08777530352  
Fax    
Email  drts.india@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tryambak Samanta 
Designation  Associate Profesor, Department of Medical Gastroenterology, Medical College, Kolkata 
Affiliation  Medical College, Kolkata 
Address  Room No 5006, 5th Floor, Super Speciality Building (department of Medical Gastroenterology) Medical College, 88, College Street, Medical College


WEST BENGAL
700073
India 
Phone  08777530352  
Fax    
Email  drts.india@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Tryambak Samanta 
Designation  Associate Profesor, Department of Medical Gastroenterology, Medical College, Kolkata 
Affiliation  Medical College, Kolkata 
Address  Room No 5006, 5th Floor, Super Speciality Building (department of Medical Gastroenterology) Medical College, 88, College Street, Medical College


WEST BENGAL
700073
India 
Phone  08777530352  
Fax    
Email  drts.india@gmail.com  
 
Source of Monetary or Material Support  
Medical College and Hospital, 88 College Street, Kolkata 73  
 
Primary Sponsor  
Name  Dr Tryambak Samanta 
Address  Room no 5006,Super Speciality Building, Department of Medical Gastroenterology, Medical College and Hospital, 88 College, Street, Kolkata -73 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tryambak Samanta  Medical College and Hospital, 88 College Street, Kolkata  Room No 5006, 5th Floor, Super Speciality Building (department of Medical Gastroenterology) Medical College, 88, College Street, Medical College
Kolkata
WEST BENGAL 
08777530352

drts.india@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH MEDICAL COLLEGE, KOLKATA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K740||Hepatic fibrosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Children less than or equal to 15 years of age

Diagnosed with pediatric chronic liver disease

Informed consent from primary caregiver 
 
ExclusionCriteria 
Details  Hemodynamic instability

Acute decompensation (overt hepatic encephalopathy, gastrointestinal bleeding) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Correlation of ultrasound-defined sarcopenia with

PELD score, Infections, Hospital stay including ICU stay, Mortality over 3 year follow-up 
Continuous follow up at 4 weeks interval with additional time point at visit to hospital due to complications of the disease and new onset infections, requirement of hospital admission and death  
 
Secondary Outcome  
Outcome  TimePoints 
Development of a composite PELD-Sarcopenia scoring model  At the time of recruitment 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/03/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

While adult studies have consistently shown sarcopenia to be an independent predictor of adverse outcomes, its burden and clinical relevance in pediatric chronic liver disease (pCLD) remain underexplored. The Pediatric End Stage Liver Disease (PELD) score, although widely used for prognostication and transplant prioritization, does not incorporate muscle mass or nutritional reserve, potentially underestimating disease severity in sarcopenic children.

Computed tomography based muscle quantification, the current reference standard, is limited in children due to radiation exposure and feasibility concerns. Ultrasonography offers a safe, radiation-free, bedside modality for assessing muscle mass which is a more apt tool for pediatric age group. Measurement of bilateral anterior thigh thickness (BATT), encompassing rectus femoris and vastus intermedius muscles, has shown good correlation with CT-derived muscle indices in preliminary pediatric studies, but its prognostic utility in pediatric chronic liver disease has not been systematically evaluated.

This prospective observational study aims to assess sarcopenia using ultrasound-derived BATT measurements in children less than or equal to 15 years with chronic liver disease and to examine its association with disease severity and clinical outcomes. Baseline BATT measurements and PELD scores will be obtained at enrollment, with participants followed prospectively for up to three years to record infections, hospital and ICU admissions, and mortality. Correlation and multivariate analyses will be performed to evaluate the independent impact of sarcopenia on outcomes and to explore the development of a composite PELD Sarcopenia score.

This study seeks to establish ultrasound based sarcopenia assessment as a feasible and clinically relevant prognostic tool in pediatric chronic liver disease and to determine whether integrating muscle mass parameters with existing scoring systems improves risk stratification and outcome prediction in this vulnerable population.

 
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