| 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
|
|
|
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
|
|
|
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. |