| 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
|
|
|
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
|
|
|
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. |