Simultaneous resection for synchronous colorectal cancer liver metastases: A feasibility clinical trial. Issue 4 (8th December 2021)

• Record Type: Journal Article
• Authors: Serrano, Pablo E.; Parpia, Sameer; Karanicolas, Paul; Gallinger, Steven; Wei, Alice C.; Simunovic, Marko; Bhandari, Mohit; Levine, Mark
• Is Part Of: Journal of surgical oncology. Volume 125:Issue 4(2022)
• Page Start: 671
• Page End: 677
• Publication Date: 2021-12-08
• Subjects: clinical trial -- colorectal cancer -- colorectal liver metastases -- feasibility -- simultaneous resection -- synchronous metastases; Cancer -- Surgery -- Periodicals; Neoplasms -- Periodicals; 616
• DOI: 10.1002/jso.26764
• Languages: English
• ISSNs: 0022-4790

Abstract

Abstract: 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.