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

NCT07272928 | Recruiting

• 1 other identifier: ASO.ChirGen.24.06
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Liver Metastasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Mortality

  Through study completion, an average of 1 year

• Overall survival

  Through study completion, an average of 1 year

• Disease-free survival

  Through study completion, an average of 1 year

• Recurrence sites

  Through study completion, an average of 1 year

• Morbidity

  Through study completion, an average of 1 year

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

SC Chirurgia Generale

Alessandria, Piedmont, 15121, Italy

RECRUITING

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Clinical Trial Center

CONTACT

0131206893; clinicaltrialcenter@ospedale.al.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 9, 2025
• Study Start: February 27, 2025
• Primary Completion: August 27, 2025
• Study Completion (Estimated): August 27, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)