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NCT Number: NCT07272928

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SC Chirurgia Generale

Alessandria, Piedmont, 15121, Italy

Location status: Recruiting

Location contact

SC Chirurgia Generale

CONTACT

[email protected]

0131206893

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data collection

Procedure

Data collection to assess whether the order of resection of the site in a simultaneous approach (liver first vs. colon first) in colorectal cancer with liver metastases affects overall postoperative morbidity.

Primary outcomes

  1. Difference in overall morbidity rates

    Time frame: Through study completion, an average of 1 year

    Measurement of the difference in overall morbidity rates between both approaches (liver first vs. colon first) in colorectal cancer with liver metastasis influences postoperative

Secondary outcomes

  1. Mortality

    Time frame: Through study completion, an average of 1 year

    Evaluation of the postoperative mortality for both approaches, (liver first vs. colon first), when performed via laparoscopic or robotic surgery

  2. Overall survival

    Time frame: Through study completion, an average of 1 year

    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

  3. Disease-free survival

    Time frame: Through study completion, an average of 1 year

    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

  4. Recurrence sites

    Time frame: Through study completion, an average of 1 year

    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

  5. Morbidity

    Time frame: Through study completion, an average of 1 year

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trial Center

CONTACT

[email protected]

0131206893

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Other

Registry information

Official study title

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

Acronym: CORSICO

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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