Buscail Louis, Culetto Adrian, Mokhrane Fatima-Zhora, Napoléon Bertrand, Meyrignac Olivier, Molinier Baptiste, Lebrin Marine, Bournet Barbara, Bérard Emilie, Canivet Cindy
Department of Gastroenterology and Pancreatology, CHU Toulouse-Rangueil (University Hospital Centre) and Toulouse University III, Toulouse, France.
Centre for Clinical Investigation in Biotherapy, CHU Toulouse-Rangueil and INSERM U1436, Toulouse, France.
Endosc Int Open. 2022 Jun 10;10(6):E910-E916. doi: 10.1055/a-1799-7774. eCollection 2022 Jun.
In pancreatic cancer, the antitumor effect can only be assessed by means of a computed tomography (CT) scan using RECIST (Response Evaluation Criteria in Solid Tumours) criteria. The aim of this study was to assess the intra-observer and interobserver agreement of endoscopic ultrasound (EUS) imaging in assessing tumor volume in primary pancreatic cancer. During a Phase 1 gene therapy trial, 21 patients had EUS before the first and second EUS-guided in situ gene therapy injections. All anonymized EUS files were then randomly distributed to three gastroenterologists/endosonographers and three radiologists (blind status). The largest tumor diameter was measured and the intraclass correlation coefficient (ICC) was determined. Intra-observer and interobserver agreements were good to excellent, regardless of operator experience (junior versus senior member of staff) (ICC: 0.65 to 0.84). A comparison of pretreatment and post-treatment measurements by the investigators highlighted a significant antitumor effect (-11 %; = 0.0098), similar to that obtained during the generic protocol (-10 %; = 0.0045). Interobserver agreement regarding primary pancreatic adenocarcinoma measurements appears good to excellent, thus paving the way for the future inclusion of EUS assessments, particularly in trials assessing local therapies for pancreatic tumors.
在胰腺癌中，抗肿瘤效果只能通过使用实体瘤疗效评价标准（RECIST）的计算机断层扫描（CT）来评估。本研究的目的是评估内镜超声（EUS）成像在评估原发性胰腺癌肿瘤体积时观察者内和观察者间的一致性。在一项1期基因治疗试验中，21例患者在首次和第二次EUS引导下原位基因治疗注射前接受了EUS检查。然后将所有匿名的EUS文件随机分发给三名胃肠病学家/内镜超声医师和三名放射科医生（盲态）。测量最大肿瘤直径并确定组内相关系数（ICC）。无论操作者经验（初级与高级工作人员）如何，观察者内和观察者间的一致性均为良好至优秀（ICC：0.65至0.84）。研究者对治疗前和治疗后测量值的比较突出显示了显著的抗肿瘤效果（-11%；P = 0.0098），与通用方案期间获得的效果相似（-10%；P = 0.0045）。关于原发性胰腺腺癌测量的观察者间一致性似乎为良好至优秀，从而为未来纳入EUS评估铺平了道路，特别是在评估胰腺肿瘤局部治疗的试验中。
