Abstract
BackgroundRadiofrequency ablation (RFA) and microwave ablation (MWA) are widely accepted techniques to eliminate small unresectable colorectal liver metastases (CRLM). Although previous studies labelled thermal ablation inferior to surgical resection, the apparent selection bias when comparing patients with unresectable disease to surgical candidates, the superior safety profile, and the competitive overall survival results for the more recent reports mandate the setup of a randomized controlled trial. The objective of the COLLISION trial is to prove non-inferiority of thermal ablation compared to hepatic resection in patients with at least one resectable and ablatable CRLM and no extrahepatic disease.MethodsIn this two-arm, single-blind multi-center phase-III clinical trial, six hundred and eighteen patients with at least one CRLM (≤3 cm) will be included to undergo either surgical resection or thermal ablation of appointed target lesion(s) (≤3 cm). Primary endpoint is OS (overall survival, intention-to-treat analysis). Main secondary endpoints are overall disease-free survival (DFS), time to progression (TTP), time to local progression (TTLP), primary and assisted technique efficacy (PTE, ATE), procedural morbidity and mortality, length of hospital stay, assessment of pain and quality of life (QoL), cost-effectiveness ratio (ICER) and quality-adjusted life years (QALY).DiscussionIf thermal ablation proves to be non-inferior in treating lesions ≤3 cm, a switch in treatment-method may lead to a reduction of the post-procedural morbidity and mortality, length of hospital stay and incremental costs without compromising oncological outcome for patients with CRLM.Trial registrationNCT03088150, January 11th 2017.
Highlights
Radiofrequency ablation (RFA) and microwave ablation (MWA) are widely accepted techniques to eliminate small unresectable colorectal liver metastases (CRLM)
Primary and assisted technique efficacy rates (PTE, Assisted technique efficacy (ATE)) defined as the percentage of target lesions that have recurred after the initial local treatment and after additional local treatments regardless of the technique(s) used to treat the recurrence with a minimum follow-up period of 12 months after the last focal therapy;- Direct and indirect total cost of care for both treatment arms will be registered in the cost-effectiveness data collection matrix
We expect even lower indirect costs for patients treated within the study, primarily because thermal ablation of resectable CRLM in patients who by definition qualify as suitable for surgery may be associated with an even lower complication-rate
Summary
Participating centres should have extensive experience in the field of both hepatic surgery and thermal liver tumour ablation, defined as performing ≥20 procedures annually. Patients included in study arm A will undergo resection of hepatic metastases, allowing thermal ablation for additional unresectable lesions. Primary and assisted technique efficacy rates (PTE, ATE) defined as the percentage of target lesions that have recurred after the initial local treatment and after additional local treatments regardless of the technique(s) used to treat the recurrence with a minimum follow-up period of 12 months after the last focal therapy;- Direct and indirect total cost of care for both treatment arms will be registered in the cost-effectiveness data collection matrix Based on this matrix a cost–utility analysis, measured in terms of years of full health lived, using quality-adjusted life years will be prospectively calculated. We expect even lower indirect costs for patients treated within the study, primarily because thermal ablation of resectable CRLM in patients who by definition qualify as suitable for surgery may be associated with an even lower complication-rate
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