Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
J Surg Oncol. 2022 Mar;125(4):671-677. doi: 10.1002/jso.26764. Epub 2021 Dec 8.
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.
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%.
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%).
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.
我们检验了同时切除临床试验在同步结直肠癌肝转移患者中的可行性，以获取计划随机试验所需的信息。
多中心可行性单臂试验纳入符合同时切除条件的同步结直肠癌肝转移患者。可行性的预设标准为：入组的合格患者比例≥66%，且完成同时切除的入组患者比例≥75%。预设的 90 天主要术后并发症发生率为 30%。
2017 年 2 月至 2019 年 8 月期间，共有 61 名符合条件的患者，其中 41 名入组（67%；95%置信区间，55%-78%），32 名患者接受了同时切除（78%；95%置信区间，63%-88%）。有 4 名患者因外科医生的偏好未入组，3 名患者因切除的复杂性（右半肝切除术和低位前切除术）未入组。肝切除术中并发症（n=4）和疾病进展（n=4）是未行同时切除的主要原因。90 天主要并发症发生率为 41%（95%置信区间，16%-58%），90 天术后死亡率为 6%（95%置信区间，1.7%-20%）。
根据预设标准，招募同步结直肠癌肝转移患者参加同时切除临床试验是可行的；但与预期相比，90 天术后并发症发生率较高。
