Giannone Fabio, Capretti Giovanni, Abu Hilal Mohammed, Boggi Ugo, Campra Donata, Cappelli Carla, Casadei Riccardo, De Luca Raffaele, Falconi Massimo, Giannotti Gabriele, Gianotti Luca, Girelli Roberto, Gollini Paola, Ippolito Davide, Limerutti Giorgio, Maganuco Lorenzo, Malagnino Valeria, Malleo Giuseppe, Morone Mario, Mosconi Cristina, Mrakic Federica, Palumbo Diego, Salvia Roberto, Sgroi Salvatore, Zerbi Alessandro, Balzano Gianpaolo
From the Division of Pancreatic Surgery, Pancreas Translational and Clinical Research Center, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Pancreatic Surgery Unit, Humanitas Clinical and Research Center-IRCCS, Rozzano, Milan, Italy.
Ann Surg Open. 2021 Aug 11;2(3):e087. doi: 10.1097/AS9.0000000000000087. eCollection 2021 Sep.
To determine the reproducibility of the National Comprehensive Cancer Network (NCCN) resectability status classification for pancreatic cancer.
The NCCN classification defines 3 resectability classes (resectable, borderline resectable, locally advanced), according to vascular invasion. It is used to recommend different approaches and stratify patients during clinical trials.
Prospective, multicenter, observational study (trial ID: NCT03673423). Main outcome measure was the interobserver agreement of tumor assignment to different resectability classes and quantification of vascular invasion degrees. Agreement was measured by Fleiss' k (k = 1 perfect agreement; k = 0 agreement by chance). Sixty-nine computed tomography (CT) scans of pathologically confirmed pancreatic adenocarcinoma were independently reviewed in a blinded fashion by 22 observers from 11 hospitals (11 surgeons and 11 radiologists). Rating differences between surgeons or radiologists and between hospitals with different volumes (≥60 or <60 resections/year) were assessed.
Complete agreement among 22 observers was recorded in 5 CT scans (7.2%), whereas 25 CT scans (36.2%) were variously assigned to all 3 resectability classes. Interobserver agreement varied from fair to moderate (Fleiss' k range: 0.282-0.555), with the lowest agreement for borderline resectable tumors. Assessing vascular contact ≤180° had the lowest agreement for all vessels (k range: 0.196-0.362). The highest concordance was recorded for venous invasion >180° (k range: 0.619-0.756). Neither reviewers' specialty nor hospital volume influenced the agreement.
There is high variability in the assignment to resectability categories, which may compromise the reliability of treatments recommendations and the evidence of trials stratifying patients in resectability classes. Criteria should be revised to allow a reproducible classification.
确定美国国立综合癌症网络（NCCN）胰腺癌可切除性状态分类的可重复性。
NCCN分类根据血管侵犯情况定义了3种可切除性类别（可切除、边缘可切除、局部进展期）。它用于在临床试验期间推荐不同的治疗方法并对患者进行分层。
前瞻性、多中心、观察性研究（试验编号：NCT03673423）。主要结局指标是观察者间对肿瘤归入不同可切除性类别的一致性以及血管侵犯程度的量化。一致性通过Fleiss' k检验衡量（k = 1为完全一致；k = 0为偶然一致）。来自11家医院的22名观察者（11名外科医生和11名放射科医生）以盲法独立审查了69例经病理证实的胰腺腺癌的计算机断层扫描（CT）图像。评估了外科医生或放射科医生之间以及不同手术量（≥60例或<60例/年）的医院之间的评级差异。
22名观察者对5例CT图像（7.2%）达成了完全一致，而25例CT图像（36.2%）被不同程度地归入了所有3种可切除性类别。观察者间一致性从中度到良好不等（Fleiss' k范围：0.282 - 0.555），边缘可切除肿瘤的一致性最低。评估血管接触≤180°时，所有血管的一致性最低（k范围：0.196 - 0.362）。静脉侵犯>180°时的一致性最高（k范围：0.619 - 0.756）。审查者的专业和医院手术量均未影响一致性。
可切除性类别的划分存在很大差异，这可能会损害治疗建议的可靠性以及在可切除性类别中对患者进行分层的试验证据。应修订标准以实现可重复的分类。
