Simultaneous resection for synchronous colorectal cancer liver metastases: A feasibility clinical trial

• Published in: Journal of surgical oncology 2022-03, Vol.125 (4), p.671-677
• Main Authors: Serrano, Pablo E., Parpia, Sameer, Karanicolas, Paul, Gallinger, Steven, Wei, Alice C., Simunovic, Marko, Bhandari, Mohit, Levine, Mark
• Format: Article
• Language: English
• Subjects: Aged; clinical trial; Clinical trials; Colorectal cancer; colorectal liver metastases; Colorectal Neoplasms - pathology; Colorectal Neoplasms - surgery; feasibility; Feasibility Studies; Female; Follow-Up Studies; Hepatectomy - methods; Humans; Laparoscopy - methods; Liver; Liver Neoplasms - pathology; Liver Neoplasms - surgery; Male; Metastasis; Middle Aged; Neoplasms, Multiple Primary - pathology; Neoplasms, Multiple Primary - surgery; Prognosis; Prospective Studies; simultaneous resection; synchronous metastases
• ISSN: 0022-4790; 1096-9098
• DOI: 10.1002/jso.26764

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.