An observational study in Colorectal Liver Metastasis, sponsored by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-09.
Sponsored by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria · Observational
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.
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.
4,040 studies on the registry are indexed under Neoplasm Metastasis; 886 are open to participants now.
This study's planned enrollment of 500 is above the median of 136 across 557 observational studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria is the lead sponsor of 37 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing simultaneous treatment of colorectal cancer and liver metastases using open, laparoscopic, and robotic surgery between 2015 and 2023 in participating centers
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
Time frame: Through study completion, an average of 1 year
Mortality
Evaluation of the postoperative mortality for both approaches, (liver first vs. colon first), when performed via laparoscopic or robotic surgery
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through study completion, an average of 1 year
Plan to share: No
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Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria