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Table 1 In- and exclusion criteria

From: Colorectal liver metastases: surgery versus thermal ablation (COLLISION) – a phase III single-blind prospective randomized controlled trial

Inclusion criteria Exclusion criteria
Histological documentation of primary colorectal tumour No target lesions suitable for both resection and ablation
Age > 18 years Radical treatment unfeasible or unsafe (e.g. insufficient future liver remnant [FLR])
At least one CRLM size ≤3 cm eligible for both surgical resection and thermal ablation (target lesions) Any surgical resection or focal ablative liver therapy for CRLM prior to inclusion
Additional unresectable CRLM should be ≤3 cm and ablatable The presence of extrahepatic nodal or non-nodal metastases
Additional unablatable CRLM should be resectable Immunotherapy ≤6 weeks prior to the procedure
Maximum number of CRLM 10 Chemotherapy ≤6 weeks prior to the procedure
Resection for resectable lesions considered possible obtaining negative resection margins (R0) and preserving adequate liver reserve Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment
Resectability and ablatability should be re-confirmed by intra-operative ultrasound (IOUS) and full surgical exploration Compromised liver function (e.g. signs of portal hypertension, INR > 1,5 without use of anticoagulants, ascites)
Eastern Cooperative Oncology Group status (ECOG) 0–2 Uncontrolled infections (> grade 2 NCI-CTC version 3.0)
American Society of Anesthesiologists (ASA) grade 1–3 Severe allergy to contrast media not controlled with premedication
Life expectancy of at least 12 weeks Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study;
Adequate bone marrow, liver, and renal function as assessed by local usual laboratory tests. As usual, these results should be judged by the local investigator and should be conducted within 7 days prior to definite inclusion.
Written informed consent
Substance abuse, medical, psychological or social conditions