Comparison of the Resection Site Order in Simultaneous Approach of Colorectal Liver Metastasis (CORSICO)

Comparison of the Resection Site Order in Simultaneous Approach of Colorectal Liver Metastasis. An International Multicentric Retrospective Trial.

Colorectal cancer frequently presents with liver metastases, and complete removal of both primary and liver tumors can significantly improve survival. Simultaneous resection (SA) of the colon and liver is increasingly used and is considered safe when minor liver resections are performed, offering advantages such as shorter hospitalization, fewer complications, and faster chemotherapy initiation.

However, the best sequence of resection, liver-first or colon-first, remains uncertain, as each has potential benefits and drawbacks, particularly regarding anastomotic healing. Minimally invasive approaches to SA show similar outcomes to open surgery, though limited data suggest that resection order may affect blood loss.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Liver Metastasis
• Intervention / Treatment: Procedure: Data collection

Detailed Description

Colorectal cancer is the third most common cancer worldwide, and 15-25% of patients present with liver metastases at diagnosis. Complete resection of both the primary tumor and liver metastases can yield survival rates up to 47.9%. Simultaneous resection (SA) of the colon and liver is a potential option for patients with synchronous metastases, though traditionally considered high-risk, especially when major hepatectomies are involved.

Recent studies show that SA is safe when minor hepatectomies are paired with standard colon resections and may offer advantages such as reduced hospital stay, lower costs, fewer complications, and faster initiation of chemotherapy.

The optimal sequence of resection in SA remains unclear. Liver-first procedures may preserve sterility and address the prognostically significant lesion first but could impair bowel anastomosis healing.

Minimally invasive surgery (MIS), including laparoscopic and robotic approaches, is increasingly used for SA and appears comparable to open surgery in terms of morbidity, mortality, and oncologic outcomes. Early data on MIS suggest that resection order may influence intraoperative blood loss, but findings remain inconsistent and require further investigation.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Clinical Trial Center; Phone Number: 0131206893; Email: clinicaltrialcenter@ospedale.al.it

Study Locations

• Italy
  • Piedmont
    • Alessandria, Piedmont, Italy, 15121
      • Recruiting
      • SC Chirurgia Generale
      • Contact: SC Chirurgia Generale; Phone Number: 0131206893; Email: fabio.giannone@ospedale.al.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients undergoing simultaneous treatment of colorectal cancer and liver metastases using open, laparoscopic, and robotic surgery between 2015 and 2023 in participating centers

Description

Inclusion Criteria:

• Adult patients diagnosed with colorectal cancer with synchronous liver metastases during the reference period, who underwent simultaneous resection.

Exclusion Criteria:

• Simultaneous emergency resection due to symptoms of the primary tumor.
• Presence of extrahepatic metastatic disease confirmed at the time of resection or diagnosis.
• High surgical risk defined as an ASA risk score greater than 3.
• At least 10 cases performed by the invited center during the study period.
• Incomplete data or follow-up of less than 6 months.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in overall morbidity rates	Measurement of the difference in overall morbidity rates between both approaches (liver first vs. colon first) in colorectal cancer with liver metastasis influences postoperative	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Evaluation of the postoperative mortality for both approaches, (liver first vs. colon first), when performed via laparoscopic or robotic surgery	Through study completion, an average of 1 year
Overall survival	Compare the overall survival of patients with a diagnosis of colorectal cancer between both approaches (liver first vs. colon first), when performed via laparoscopic or robotic surgery	Through study completion, an average of 1 year
Disease-free survival	Compare the disease-free survival of patients with a diagnosis of colorectal cancer between both approaches (liver first vs. colon first), when performed via laparoscopic or robotic surgery	Through study completion, an average of 1 year
Recurrence sites	Compare the recurrence sites in patients with a diagnosis of colorectal cancer between both approaches (liver first vs. colon first), when performed via laparoscopic or robotic surgery	Through study completion, an average of 1 year
Morbidity	Compare the morbidity in patients with a diagnosis of colorectal cancer between both approaches (liver first vs. colon first), when performed via laparoscopic or robotic surgery	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2025
• Primary Completion (Actual): August 27, 2025
• Study Completion (Estimated): August 27, 2026

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Estimated): December 9, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Data Collection
• Other Study ID Numbers: ASO.ChirGen.24.06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No