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

Background: Radiofrequency 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. Methods: In this two-arm, single-blind multi-center phase-III clinical trial, six hundred and eighteen patients with at least one CRLM (≤3cm) will be included to undergo either surgical resection or thermal ablation of appointed target lesion(s) (≤3cm). 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). Discussion: If thermal ablation proves to be non-inferior in treating lesions ≤3cm, 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 registration:NCT03088150 , January 11th 2017

The impact of prehospital blood sampling on the emergency department process of patients with chest pain: a pragmatic non-randomized controlled trial

BACKGROUND: In patients with chest pain who arrive at the emergency department (ED) by ambulance, venous access is frequently established prehospital, and could be utilized to sample blood. Prehospital blood sampling may save time in the diagnostic process. In this study, the association of prehospital blood draw with blood sample arrival times, troponin turnaround times, and ED length of stay (LOS), number of blood sample mix-ups and blood sample quality were assessed. METHODS: The study was conducted from October 1, 2019 to February 29, 2020. In patients who were transported to the ED with acute chest pain with low suspicion for acute coronary syndrome (ACS), outcomes were compared between cases, in whom prehospital blood draw was performed, and controls, in whom blood was drawn at the ED. Regression analyses were used to assess the association of prehospital blood draw with the time intervals. RESULTS: Prehospital blood draw was performed in 100 patients. In 406 patients, blood draw was performed at the ED. Prehospital blood draw was independently associated with shorter blood sample arrival times, shorter troponin turnaround times and decreased LOS (P<0.001). No differences in the number of blood sample mix-ups and quality were observed (P>0.05). CONCLUSION: For patients with acute chest pain with low suspicion for ACS, prehospital blood sampling is associated with shorter time intervals, while there were no significant differences between the two groups in the validity of the blood samples