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CTRI Number  CTRI/2025/07/090078 [Registered on: 02/07/2025] Trial Registered Prospectively
Last Modified On: 01/07/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   An international multicentre observational study to find out whether removing bowel cancer or liver tumors first gives better results in patients who have cancer in both places and need surgery for both 
Scientific Title of Study   Comparison of the resection site order in simultaneous approach of colorectal liver metastasis. An international multicentric retrospective trial (CORSICO Study) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Project no 4730_V_2.0 Dated 29JAN2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mahesh Goel 
Designation  Professor, Chief Hepatobiliary Surgeon 
Affiliation  Tata Memorial Hospital 
Address  Room no 1224 Homi Bhabha Building, Dr E Borges Road, Parel,

Mumbai
MAHARASHTRA
400012
India 
Phone  9820504492  
Fax    
Email  drmaheshgoel@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mahesh Goel 
Designation  Professor, Chief Hepatobiliary Surgeon 
Affiliation  Tata Memorial Hospital 
Address  Room no 1224 Homi Bhabha Building, Dr E Borges Road, Parel,


MAHARASHTRA
400012
India 
Phone  9820504492  
Fax    
Email  drmaheshgoel@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mahesh Goel 
Designation  Professor, Chief Hepatobiliary Surgeon 
Affiliation  Tata Memorial Hospital 
Address  Room no 1224 Homi Bhabha Building, Dr E Borges Road, Parel,


MAHARASHTRA
400012
India 
Phone  9820504492  
Fax    
Email  drmaheshgoel@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Dr E Borges Road Parel, Mumbai, Maharashtra, India 400012 
 
Primary Sponsor  
Name  European Federation International Society of Digestive Surgery Coordinating center 
Address  SCDU Chirurgia Generale - Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo, Alessandria, Via Venezia, 16, 15121 Alessandria (AL), Italy 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India
Italy  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mahesh Goel  Tata Memorial Hospital, Mumbai  OPD no 319, Surgical Oncology OPD, Gastro-intestinal Disease Mangement Group, 3rd Floor, Homi Bhabah Building, Dr E Borgs Road, Parel
Mumbai
MAHARASHTRA 		 9820504492

drmaheshgoel@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Hospital Institutional Ethics Committee -II  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Adult patients with a diagnosis of colorectal cancer with synchronous liver metastasis between the referred period, who underwent simultaneous resection of primary tumor and hepatic metastasis. 
 
ExclusionCriteria 
Details  1. Emergency simultaneous resections
2. Proven extrahepatic metastatic disease at the time of diagnosis or at resection.
3. At least 10 cases performed by the invited center during the study period.
4. Incomplete records or less than 6 months of follow-up. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Difference in overall morbidity rates between both approaches.  90 days after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Difference in mortality rates between both approaches.  90 days after surgery 
Difference in morbidity associated to liver and morbidity associated to colon, between the approaches.  90 days after surgery 
Difference in oncological outcomes between the two approaches.  1-year and at 5-years after surgery data 
Difference in postoperative and oncological outcomes between the two approaches, when performed via laparoscopic or robotic surgery.  1-year and at 5-years after surgery data 
 
Target Sample Size   Total Sample Size="564"
Sample Size from India="100" 
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)   15/06/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/04/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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  

Treating colorectal cancer that has spread to the liver involves complex surgical decisions. When both the primary colorectal tumor and liver metastases are removed simultaneously, there is an ongoing debate about the best sequence in which these surgeries should be performed-whether to operate on the liver first (Primary Liver Stage) or the colon first (Primary Colon Stage). Different studies have reported varying outcomes for each approach, making it difficult to determine a universally preferred method.

The CORSICO study aims to determine whether the order of resection (removal of cancerous tissue) in a simultaneous surgery for colorectal cancer with liver metastasis affects post-surgery complications. It compares two approaches:

  1. Primary Liver Stage (PLS) – where the liver is operated on first.
  2. Primary Colon Stage (PCS) – where the colon is operated on first.


Objectives: The primary objective is to compare oncological outcomes, including overall survival, disease-free survival, and recurrence sites, between the two surgical the liver first (Primary Liver Stage) or the colon first (Primary Colon Stage) approaches

Study Type: Observational, multi-center, retrospective study.

Population: Patients who underwent simultaneous colorectal cancer and liver metastasis surgery from 2015 to June 2024.

Inclusion Criteria: Adults diagnosed with colorectal cancer and liver-only metastases who underwent simultaneous surgery.

Exclusion Criteria: Patients with extrahepatic metastasis, emergency surgeries, and incomplete records

Outcome Measures:

  • Primary Outcome: The primary outcome of study is to compare overall complication rates between Primary Liver Stage  and Primary Colon Stage
  • Secondary Outcomes:
    • Compare surgery-related deaths and complications for both approaches.
    • Analyze long-term survival and cancer recurrence rates.
    • Evaluate outcomes for robotic vs. laparoscopic vs. open surgeries.
  • Sample Size: 564 patients (256 in each group + 10% extra for potential dropouts).100 patients will be enrolled from TMH.

In this study, researchers will not conduct new procedures but will only analyze anonymized data that has already been collected from patient medical records. No additional tests or interventions will be performed on patients. Strict confidentiality measures will be in place, ensuring that personal information remains protected and is only accessible to the research team. The collected data will be securely transferred to the coordinating center, through a secure electronic system known as REDCap where it will be analyzed and used to generate results for publication, contributing to improved surgical strategies for colorectal cancer with liver metastases.

 
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