Digestive Tumours Unit, Institut Bergonié, Comprehensive Cancer Centre, 229 Cours de l'Argonne, 33076, Bordeaux, France.
Clinical Research and Clinical Epidemiology Unit, Institut Bergonié, Comprehensive Cancer Centre, 229 Cours de l'Argonne, 33076, Bordeaux, France; Université de Bordeaux, 146 rue Léo Saignat, 33000, Bordeaux, France.
Eur J Surg Oncol. 2019 Jul;45(7):1212-1218. doi: 10.1016/j.ejso.2019.03.002. Epub 2019 Mar 10.
Detecting more colorectal liver metastases (CRLMs) during surgery may help optimise strategy and improve outcomes. Our objective was to determine clinical utility (CU) of contrast-enhanced intra-operative ultrasound (CE-IOUS) using sulphur hexafluoride microbubbles during CRLM surgery.
A prospective phase II trial performed at two comprehensive cancer research centres. Patients operated for CRLMs were eligible and assessable if intra-operative ultrasound (IOUS) and CE-IOUS had been performed and pathological results were available and/or 3-month imaging. CU was defined as the justified change in planned surgical strategy or procedure using CE-IOUS.
Out of the 68 patients enrolled, 54 were eligible and assessable. 43 patients underwent pre-operative chemotherapy. The median number of CRLMs was 2 (range, 1-11). Pre-operative staging was performed using MRI. IOUS allowed identification of 45 new CRLMs in 13 (24.7%) patients. Compared to IOUS, CE-IOUS allowed identification of 10 additional CRLMs in 9 (16.7%) patients. Surgery was altered and justified in 4 patients only, leading to a CU rate of 7.70% (95 CI, [3.2, 18.6]). No missing CRLMs were identified by CE-IOUS.
Although the primary endpoint was not met for one protocol violation, secondary endpoints indicate that CE-IOUS has an intermediate added-value for surgeons treating CRLMs.
NCT01880554 (https://clinicaltrials.gov/).
术中检测到更多结直肠癌肝转移（CRLM）可能有助于优化策略并改善预后。我们的目的是确定术中使用六氟化硫微泡增强超声（CE-IOUS）检测 CRLM 手术中 CRLM 的临床效用（CU）。
在两个综合癌症研究中心进行了一项前瞻性 II 期试验。如果术中超声（IOUS）和 CE-IOUS 已进行，且病理结果可用和/或 3 个月影像学检查，则对接受 CRLM 手术的患者进行评估。CU 定义为使用 CE-IOUS 改变计划的手术策略或程序。
在纳入的 68 例患者中，有 54 例符合条件并可评估。43 例患者接受了术前化疗。CRLM 的中位数为 2（范围，1-11）个。术前分期采用 MRI 进行。IOUS 在 13 例（24.7%）患者中发现了 45 个新的 CRLM。与 IOUS 相比，CE-IOUS 在 9 例（16.7%）患者中发现了 10 个额外的 CRLM。仅 4 例患者的手术发生了改变和证实，导致 CU 率为 7.70%（95%CI，[3.2, 18.6]）。CE-IOUS 未发现遗漏的 CRLM。
尽管因违反方案 1 例而未达到主要终点，但次要终点表明，CE-IOUS 对治疗 CRLM 的外科医生具有中等附加价值。
NCT01880554（https://clinicaltrials.gov/）。
