Digestive Diseases Department, Althaia Xarxa Assistencial Universitària de Manresa, Barcelona, Spain; Universitat Internacional de Catalunya, Barcelona, Spain.
Gastroenterology Department, Institut de Malalties Digestives i Metabòliques, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain.
Gastroenterology. 2019 Jan;156(1):75-87. doi: 10.1053/j.gastro.2018.10.004. Epub 2018 Oct 6.
BACKGROUND & AIMS: T1 colorectal polyps with at least 1 risk factor for metastasis to lymph node should be treated surgically and are considered endoscopically unresectable. Optical analysis, based on the Narrow-Band Imaging International Colorectal Endoscopic (NICE) classification system, is used to identify neoplasias with invasion of the submucosa that require endoscopic treatment. We assessed the accuracy of the NICE classification, along with other morphologic characteristics, in identifying invasive polyps that are endoscopically unresectable (have at least 1 risk factor for metastasis to lymph node).
We performed a multicenter, prospective study of data collected by 58 endoscopists, from 1634 consecutive patients (examining 2123 lesions) at 17 university and community hospitals in Spain from July 2014 through June 2016. All consecutive lesions >10 mm assessed with narrow-band imaging were included. The primary end point was the accuracy of the NICE classification for identifying lesions with deep invasion, using findings from histology analysis as the reference standard. Conditional inference trees were fitted for the analysis of diagnostic accuracy.
Of the 2123 lesions analyzed, 89 (4.2%) had features of deep invasion and 91 (4.3%) were endoscopically unresectable. The NICE classification system identified lesions with deep invasion with 58.4% sensitivity (95% CI, 47.5-68.8), 96.4% specificity (95% CI, 95.5-97.2), a positive-predictive value of 41.6% (95% CI, 32.9-50.8), and a negative-predictive value of 98.1% (95% CI, 97.5-98.7). A conditional inference tree that included all variables found the NICE classification to most accurately identify lesions with deep invasion (P < .001). However, pedunculated morphology (P < .007), ulceration (P = .026), depressed areas (P < .001), or nodular mixed type (P < .001) affected accuracy of identification. Results were comparable for identifying lesions that were endoscopically unresectable.
In an analysis of 2123 colon lesions >10 mm, we found the NICE classification and morphologic features identify those with deep lesions with >96% specificity-even in non-expert hands and without magnification. ClinicalTrials.gov number NCT02328066.
至少存在 1 个淋巴结转移风险因素的 T1 结直肠息肉应进行手术治疗，且被认为内镜下无法切除。基于窄带成像国际结直肠内镜（NICE）分类系统的光学分析用于识别需要内镜治疗的黏膜下浸润性肿瘤。我们评估了 NICE 分类以及其他形态特征在识别内镜下无法切除（至少有 1 个淋巴结转移风险因素）的侵袭性息肉中的准确性。
我们对 2014 年 7 月至 2016 年 6 月期间在西班牙 17 家大学和社区医院的 58 名内镜医生对 1634 例连续患者（共 2123 个病灶）的数据进行了多中心前瞻性研究。所有连续的大于 10mm 的窄带成像评估病灶均纳入研究。主要终点是 NICE 分类识别有深部浸润病灶的准确性，以组织学分析结果作为参考标准。使用条件推断树分析诊断准确性。
在分析的 2123 个病灶中，有 89 个（4.2%）有深部浸润特征，91 个（4.3%）为内镜下无法切除。NICE 分类系统识别深部浸润病灶的敏感性为 58.4%（95%CI，47.5-68.8），特异性为 96.4%（95%CI，95.5-97.2），阳性预测值为 41.6%（95%CI，32.9-50.8），阴性预测值为 98.1%（95%CI，97.5-98.7）。包含所有变量的条件推断树发现，NICE 分类最能准确识别深部浸润病灶（P<0.001）。然而，带蒂形态（P<0.007）、溃疡（P=0.026）、凹陷区（P<0.001）或结节混合类型（P<0.001）会影响识别准确性。对于识别内镜下无法切除的病灶，结果也具有可比性。
在对 2123 个大于 10mm 的结肠病灶进行分析时，我们发现 NICE 分类和形态特征可以识别出 96%以上特异性的有深部病变的病灶，即使是在非专家手中，且不使用放大技术。临床试验注册号：NCT02328066。
