肠系膜上动脉入路与无接触入路在胰十二指肠切除术中对胰腺癌循环肿瘤细胞和簇转移的影响（CETUPANC）：随机临床试验。

Effects of the superior mesenteric artery approach versus the no-touch approach during pancreatoduodenectomy on the mobilization of circulating tumour cells and clusters in pancreatic cancer (CETUPANC): randomized clinical trial.

机构信息

Department of Surgery, Virgen del Rocío University Hospital, IBIS, University of Seville, Seville, Spain.

Health and Sciences Research Centre, Health and Sciences Faculty, Anahuac University, Huixquilucan, Mexico.

出版信息

BJS Open. 2024 Oct 29;8(6). doi: 10.1093/bjsopen/zrae123.

DOI:10.1093/bjsopen/zrae123

PMID:39485887

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11529789/

Abstract

BACKGROUND

Patients with pancreatic ductal adenocarcinoma present early postoperative systemic metastases, despite complete oncological resection. The aim of this study was to assess two pancreatoduodenectomy approaches with regard to intraoperative circulating tumour cells and cluster mobilization and their potential association with the development of distant metastasis.

METHODS

Patients with periampullary tumours who underwent open pancreatoduodenectomy were randomly allocated to either the no-touch approach or the superior mesenteric artery approach. A total of four intraoperative portal vein samples (at the beginning of the intervention, after portal vein disconnection from the tumour, after tumour resection, and before abdominal closure) were collected to measure circulating tumour cells and cluster numbers. Primary outcomes were the intraoperative number of circulating tumour cells and cluster mobilization. Further, their potential impact on 3-year distant metastasis disease-free survival and overall survival was assessed.

RESULTS

A total of 101 patients with periampullary tumours were randomized (51 in the superior mesenteric artery group and 50 in the no-touch group) and 63 patients with pancreatic ductal adenocarcinoma (34 in the superior mesenteric artery group and 29 in the no-touch group) were analysed. Circulating tumour cells and cluster mobilization were similar in both the no-touch group and the superior mesenteric artery group at all time points. There were no significant differences between surgical groups with regard to the median metastasis disease-free survival (12.4 (interquartile range 6.1-not reached) months in the superior mesenteric artery group and 18.1 (interquartile range 12.1-not reached) months in the no-touch group; P = 0.730). Patients with intraoperative cluster mobilization from the beginning to the end of surgery developed significantly more distant metastases within the first year after surgery (P = 0.023). Two intraoperative factors (the superior mesenteric artery approach (P = 0.025) and vein resection (P < 0.001)) were predictive factors for cluster mobilization.

CONCLUSION

Patients undergoing pancreatoduodenectomy using either the no-touch approach or the superior mesenteric artery approach had similar circulating tumour cells and cluster mobilization and similar overall survival and metastasis disease-free survival. A high intraoperative cluster dissemination during pancreatoduodenectomy was a predictive factor for early metastases in patients with pancreatic ductal adenocarcinoma.

REGISTRATION NUMBER

NCT03340844 (http://www.clinicaltrials.gov)-CETUPANC trial.

摘要

背景

尽管进行了完整的肿瘤学切除，但患有胰腺导管腺癌的患者在术后早期仍会出现全身性转移。本研究旨在评估两种胰十二指肠切除术方法在术中循环肿瘤细胞和簇转移方面的效果，并探讨其与远处转移发展的潜在关联。

方法

接受开腹胰十二指肠切除术的壶腹周围肿瘤患者被随机分配至无接触组或肠系膜上动脉组。总共采集 4 个门静脉样本（干预开始时、门静脉与肿瘤分离后、肿瘤切除后和腹部关闭前），以测量循环肿瘤细胞和簇数量。主要结局是术中循环肿瘤细胞和簇转移的数量。此外，还评估了它们对 3 年无远处转移疾病的生存和总生存的潜在影响。

结果

共 101 例壶腹周围肿瘤患者被随机分配（肠系膜上动脉组 51 例，无接触组 50 例），63 例胰腺导管腺癌患者（肠系膜上动脉组 34 例，无接触组 29 例）被纳入分析。在所有时间点，无接触组和肠系膜上动脉组的循环肿瘤细胞和簇转移均相似。两组在中位无转移疾病生存方面无显著差异（肠系膜上动脉组为 12.4（四分位距 6.1-未达到）个月，无接触组为 18.1（四分位距 12.1-未达到）个月；P=0.730）。术中从手术开始到结束时发生簇转移的患者在术后 1 年内发生远处转移的比例显著更高（P=0.023）。两个术中因素（肠系膜上动脉入路（P=0.025）和静脉切除（P<0.001））是簇转移的预测因素。