Staged resection: Patients randomized to staged resection will be operated according to the decision made by the tumor board meeting (liver or colorectal cancer first, based on tumor burden and symptoms), but both resections have to be done within a time period of 4-12 weeks.
Simultaneous resection: In cases with simultaneous surgery, the liver resection is performed prior to colon resection in order to keep a low central venous pressure during the first part of the surgical procedure and to avoid congestion of the anastomosis line owing to possible Pringle manoeuvre.
Study 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
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Comprehensive Complication Index, CCI — 90 days The CCI is calculated as the sum of all complications that are weighted for their severity (multiplication of the median reference values from patients and physicians). The final formula yields a continuous scale to rank the severity of any combination of complications from 0 to 100 in a single patient.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
