基准标记放置治疗食管癌或直肠癌的成功率,一项前瞻性多中心研究(FIDECHO 研究)。
Success Rate of Fiducial Markers Placement for Treatment of Esophageal or Rectal Cancers, a prospective multicenter study (FIDECHO study).
发表日期:2024 Aug 20
作者:
Marine Camus, David Karsenti, Jonathan Levy, Maira Moreno, Emmanuel Coron, Anouk Esch, Nicolas Williet, Marc Wangermez, Stéphane Koch, Jean Christophe Valats, Mathieu Pioche, Aymeric Becq, Geoffroy Vanbiervliet, Etienne Audureau, Florence Huguet, Ulriikka Chaput
来源:
GASTROINTESTINAL ENDOSCOPY
摘要:
对于已转诊接受放射治疗的食管癌或直肠癌患者,内窥镜超声 (EUS) 引导的基准标记放置缺乏有关其可行性和安全性的数据。本研究的目的是评估 EUS 引导的基准标记放置在这些适应症中的成功率。这项前瞻性多中心研究纳入了 2017 年 3 月至 2021 年 6 月期间接受治疗的直肠或食管肿瘤患者。主要终点是成功率使用预装的 22 号 EchoTip Ultra Fiducial 针®(Cook Medical,利默里克,爱尔兰)在 EUS 引导下放置基准标记,定义为至少在肿瘤近端和远端释放基准的能力。次要终点是不良事件、手术时间和整个放射治疗过程中剩余的基准标记。本研究共纳入 33 名患者,平均年龄为 64.2 岁±11.3 岁,其中 66.7% 为男性。 20 名患者患有直肠腺癌,13 名患者患有食管恶性肿瘤。基准标记放置的成功率为93.9%。在两种情况下,标记物只能在肿瘤的近端释放。平均手术时间 (±SD) 为 12.5 分钟 (±4.8)。为每位患者放置的基准标记数量为 3.8 (±0.5)。没有不良事件的报告。放疗结束时,所有患者的影像学标记物仍然可见。这项前瞻性多中心研究强调了在 EUS 下放置基准标记物对于直肠和食管肿瘤的安全性和高度成功,无不良事件,且手术时间短时间。在放射治疗期间,基准标记会随着时间的推移保持在原位。gov ID:NCT03057288。版权所有 © 2024 美国胃肠内窥镜协会。由爱思唯尔公司出版。保留所有权利。
Endoscopy Ultra-Sound (EUS)-guided fiducial marker placement in patients with esophageal or rectal cancer who have been referred for radiation therapy lacks data regarding its feasibility and safety. The aim of this study was to assess the success rate of EUS-guided fiducial marker placement in these indications.This prospective multicenter study enrolled patients with rectal or esophageal tumor, who were treated between March 2017 and June 2021. The primary endpoint was the success of fiducial markers placement under EUS guidance utilizing the preloaded 22-gauge EchoTip Ultra Fiducial needle® (Cook Medical, Limerick, Ireland), defined by the ability to release fiducials at least at proximal and distal ends of the tumor. The secondary endpoints were the adverse events, length of procedure, and remaining fiducial markers throughout radiation therapy.A total of 33 patients were included in this study, with a mean age of 64.2 years ±11.3, and 66.7% of males. Twenty patients had rectal adenocarcinoma, and 13 had esophageal malignancies. The success rate of fiducial markers placement was 93.9%. Markers could only be released at the proximal end of the tumor in two cases. The average procedure time (±SD) was 12.5 min (±4.8). The number of fiducial markers placed for each patient was 3.8 (±0.5). No adverse event was reported. At the end of radiotherapy, markers were still visible on imaging in all patients.This prospective multicenter study highlights the safety and high success of the placement of fiducial markers under EUS, for rectal and esophageal tumors, without adverse event, and with a short procedure time. Fiducial markers remain in place over time during radiation therapy.gov ID: NCT03057288.Copyright © 2024 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.