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CTRI Number  CTRI/2025/11/097903 [Registered on: 24/11/2025] Trial Registered Prospectively
Last Modified On:
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Study to Compare Liver Size Measured Before Surgery on Scans With the Actual Size Seen During Surgery 
Scientific Title of Study   A Prospective Observational Study to determine the variation in liver size on pre-operative radiology and real time intraoperative size. 
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 Sajid Qureshi 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Main Building, Ground Floor, OPD 80: Room no 14, Tata Memorial Hospital, Dr. E. Borges Marg, Parel, Mumbai -400012 , INDIA

Mumbai
MAHARASHTRA
400023
India 
Phone  9820045398  
Fax    
Email  sajidshafiques@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sajid Qureshi 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Main Building, Ground Floor, OPD 80: Room no 14, Tata Memorial Hospital, Dr. E. Borges Marg, Parel, Mumbai -400012 , INDIA

Mumbai
MAHARASHTRA
400023
India 
Phone  9820045398  
Fax    
Email  sajidshafiques@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sajid Qureshi 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Main Building, Ground Floor, OPD 80: Room no 14, Tata Memorial Hospital, Dr. E. Borges Marg, Parel, Mumbai -400012 , INDIA

Mumbai
MAHARASHTRA
400023
India 
Phone  9820045398  
Fax    
Email  sajidshafiques@hotmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Dr. E. Borges Road, Parel, Mumbai-400012 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dr. E. Borges Road, Parel, Mumbai-400012 
Type of Sponsor  Research institution and hospital 
 
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 Sajid Qureshi  Tata Memorial Hospital  Department of Pediatric Surgical Oncology, OPD 80, Ground floor, Main Building, Dr E Borges Road, Parel, Mumbai-400012 Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 
9820045398

sajidshafiques@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-II, IEC Ofiice, Dr E Borges Marg, Parel East, Mumbai 400012  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: C222||Hepatoblastoma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1. All patients aged 6 months-15 years with the diagnosis of Liver Tumor (Primary liver tumor or Secondary to the liver) undergoing liver resection in Pediatric Surgical Oncology department at TMH, Mumbai.

2.Informed consent from parents/guardians.

 
 
ExclusionCriteria 
Details  1. Unplanned liver resections for non-liver tumors.
2. Liver resections where the liver is not mobilized completely – Surface Non-anatomical resections,
exophytic lesions that do not require liver mobilization for resection.
3. Inability to measure liver size intra-operatively.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To assess and quantify the change in liver size and volume in pediatric liver surgeries.

2. To estimate the change in PRETEXT/ POST-TEXT, liver volume.

3. To explore correlations between liver size/volume and tumor characteristics (e.g., size, location, type).

4. To investigate how variations in liver size and volume impact surgical decisions and outcomes, including resection margins and complications. 
Before and during surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1. To estimate the change in PRETEXT/ POST-TEXT, liver volume.
2. To explore correlations between liver size/volume and tumor
characteristics (e.g., size, location, type).
3. To investigate how variations in liver size and volume impact surgical
decisions and outcomes, including resection margins and complications. 
Before and post surgery 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   05/11/2026 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Children with liver tumors often need surgery to remove the tumor safely. Before surgery, doctors use imaging scans like CT or MRI to see how big the liver and tumor are. But these scans may not show the full picture because the liver is tightly packed inside the rib cage and may look smaller or more compressed than it actually is. During surgery, when the liver is freed and moved out of its tight space, it can expand, making the tumor easier to remove than originally thought. This study aims to find out how much the liver’s size and volume actually change from the scans to real-time during surgery.

The goal of this study is to measure and compare liver size before and during surgery in children with liver tumors. It also aims to see if these changes affect the surgical plan like how much of the liver needs to be removed and whether these differences help achieve better outcomes. The study will also use ultrasound during surgery to see the tumor’s location and relationship with nearby blood vessels more accurately.

By understanding these changes, the research hopes to help surgeons plan safer and more effective operations. This can reduce the removal of healthy liver tissue, lower the risk of complications, and improve recovery in young patients.

 
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