Simultaneous Resection for Synchronous Colorectal Cancer Liver Metastases: A Feasibility Clinical Trial

Abstract

Introduction: Synchronous liver metastases from colorectal cancer may be resected simultaneously with the colorectal primary or as a separate staged operation, though data from randomized trials are limited. We tested the feasibility of a simultaneous resection clinical trial in order to obtain necessary information to plan a larger randomized trial. Methods: We conducted a multi-centre feasibility single arm trial that enrolled patients with synchronous colorectal cancer liver metastases eligible for simultaneous resection of the liver and primary tumour. Pre-specified criteria for feasibility were: proportion of eligible patients enrolled ≥66% and, proportion of enrolled patients who completed simultaneous resection ≥75%. Although not a component of the feasibility criteria, the pre-specified highest accepted proportion of 90-day major postoperative complications was 30%. Results: Of 61 eligible patients from February 2017 to August 2019, 41 were enrolled (67%, 95% confidence interval (CI), 55-78%) and 32 underwent simultaneous resection (78%, 95% CI, 63-88%). Four patients were not enrolled due to surgeon’s preference, 3 of which were due to complexity of resection (right hepatectomy and low anterior resection). Intraoperative complications during liver resection (n=4) and progression of disease (n=4) were the main reasons for not undergoing simultaneous resection. The 90-day incidence of Clavien-Dindo ≥ grade 3 complications was 41% (95% CI, 16-58%) and the 90-day postoperative mortality was 6% (95% CI, 1.7-20%). Conclusion: According to pre-specified criteria, enrolling patients with synchronous colorectal cancer liver metastases to a trial of simultaneous resection is feasible, however it is associated with higher than anticipated 90-day postoperative complications.