Background and objectives: We 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.
Methods: Multicenter 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%.
Results: Of 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%).
Conclusion: According 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.
Keywords: clinical trial; colorectal cancer; colorectal liver metastases; feasibility; simultaneous resection; synchronous metastases.
© 2021 Wiley Periodicals LLC.