Simultaneous resection for synchronous colorectal cancer liver metastases: A feasibility clinical trial
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AbstractBackground and ObjectivesWe tested the feasibility of a simultaneous resection clinical trial in patients with synchronous colorectal cancer liver metastases to obtain the necessary information to plan a randomized trial.MethodsMulticenter feasibility single‐arm trial enrolling patients with synchronous colorectal cancer liver metastases eligible for simultaneous resection. Prespecified criteria for feasibility were: proportion of eligible patients enrolled ≥66%, and the proportion of enrolled patients who completed simultaneous resection ≥75%. The prespecified 90‐day major postoperative complication rate was 30%.ResultsOf 61 eligible patients from February 2017 to August 2019, 41 were enrolled (67%; 95% confidence interval [CI], 55%–78%), 32 underwent simultaneous resection (78%; 95% CI, 63%–88%). Four patients were not enrolled due to the surgeon's preference, three were due to the 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 major complications was 41% (95% CI, 16%–58%) and the 90‐day postoperative mortality was 6% (95% CI, 1.7%–20%).ConclusionAccording to prespecified 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.
