Simultaneous vs. Staged Resection of Colorectal Cancer With Synchronous Liver Metastases

Summary

The SYLMET Trial is a randomized trial to compare simultaneous and two-staged resection of primary colorectal and synchronous liver metastases. This is an investigator-initiated, multicentre, randomized controlled trial to assess complications (primary endpoint), survival, cost-effectiveness, and quality of life (secondary endpoints).This trial will include patients with resectable primary tumour in the colon or upper rectum with less than five liver metastases that is possible to treat with surgical resection and/or ablation (RFA/MWA) at time of evaluation.

Eligibility

Inclusion Criteria:

* Age 18-80 years old.
* Both CRC and liver metastases in situ at time of evaluation.
* Resectable primary tumor in the colon or upper rectum.
* Less than 5 liver metastases, evaluated by the multidisciplinary tumor board meeting as possible to treat with surgical resection and/or ablation (RFA/MWA).

Exclusion Criteria:

* Unresectable primary tumor.
* Locally advanced primary tumor (T4).
* Primary tumor in the lower rectum with indication for abdominoperineal resection.
* Acute or imminent bowel obstruction.
* Perforation or major bleeding from the primary tumor.
* Pre-treatment of the primary tumor with a colon stent.
* Liver resection requiring resection of more than 2 adjacent segments (Couinaud).
* Liver metastases planned treated with irreversible electroporation (IRE).
* Non-resectable lung metastases.
* Metastases outside of liver (besides resectable lung metastases).
* Eastern Cooperative Oncology Group (ECOG) Performance status ≥ 3.

Conditions7

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