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

NCT ID: NCT07272928

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-27
• Study Completion Date: 2026-08-27

Brief Summary

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.

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.

Conditions

Colorectal Liver Metastasis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Data collection

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

SC Chirurgia Generale

Alessandria, Piedmont, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Clinical Trial Center

Role: CONTACT

clinicaltrialcenter@ospedale.al.it

0131206893

Facility Contacts

SC Chirurgia Generale

Role: primary

fabio.giannone@ospedale.al.it

0131206893

Other Identifiers

ASO.ChirGen.24.06

Identifier Type: -

Identifier Source: org_study_id