Evaluation of 2 Resection Strategies of Synchronous Colorectal Cancer Metastases

Prospective Randomized Study Comparing the Morbidity and Mortality After Liver Resection for Synchronous Colorectal Cancer Metastases When Performed Either During or 12 to 14 Weeks After the Primary Resection

The surgical strategy for the treatment of synchronous colorectal cancer liver metastases has not still been defined. The purpose of this study is to compare two treatment strategies in which liver resection is performed either during, or 12 to 14 weeks after the primary resection. Endpoints include the rate of severe complications and survival.

In France, 35 000 colorectal cancers are diagnosed each year, 15 to 25% of which with hepatic metastases. It is nowadays admitted that the complete resection of these hepatic metastases represents the only treatment that has been shown to increase survival. The aim of this study is to evaluate the efficacy/safety ratio of the liver surgery when performed simultaneously or at distance of the primitive tumour ablation. Patients are randomized to undergo liver surgery either during, or 12 to 14 weeks after the primary resection. The primary endpoint is the rate of patients with at least one severe complication within 60 days after surgery. Secondary endpoints evaluate long-term clinical outcomes, in particular recurrence-free survival.

Inclusion Criteria:

• Male and female adults over 18 years old
• At least one adenocarcinoma of colon and/or rectum, histologically proven.
• No local complication at the time of surgery (no occlusion, no sub-occlusion, no massive hemorrhage, no abscesses or local invasion)
• At least one hepatic metastasis which R0 resection is possible through a conventional simple resection
• Informed written consent.

Non inclusion criteria:

• Heart, Respiratory or Renal failure
• Physical or psychological dependence
• Chronic liver disease
• Extra-hepatic metastases

Exclusion Criteria (at time of surgery)

• Localized or diffuse peritoneal carcinomatosis
• Non resectable lymph node metastases
• Colorectal or hepatic tumour extension towards abdominal wall and/or adjacent organ making liver R0 resection impossible immediately
• Other hepatic lesions diagnosed with ultrasound making liver R0 resection impossible immediately