使用广域跨上皮采样提高 Barrett 食管相关肿瘤的检出率:一项多中心、前瞻性、随机试验。
Increased detection of Barrett's esophagus-associated neoplasia using wide-area trans-epithelial sampling: a multicenter, prospective, randomized trial.
机构信息
Department of Gastroenterology and Hepatology, Veterans Affairs Medical Center, Kansas City, Missouri, USA; Department of Gastroenterology, University of Kansas School of Medicine, Kansas City, Kansas, USA.
Department of Gastroenterology, University of Rochester, Rochester, New York, USA.
出版信息
Gastrointest Endosc. 2018 Feb;87(2):348-355. doi: 10.1016/j.gie.2017.07.039. Epub 2017 Jul 27.
BACKGROUND AND AIMS
Wide-area transepithelial sampling (WATS) with computer-assisted 3-dimensional analysis is a sampling technique that combines abrasive brushing of the Barrett's esophagus (BE) mucosa followed by neural network analysis to highlight abnormal-appearing cells.
METHODS
We performed a randomized trial of referred BE patients undergoing surveillance at 16 medical centers. Subjects received either biopsy sampling followed by WATS or WATS followed by biopsy sampling. The primary outcome was rate of detection of high-grade dysplasia/esophageal adenocarcinoma (HGD/EAC) using WATS in conjunction with biopsy sampling compared with biopsy sampling alone using standard histopathologic criteria. Secondary aims included evaluating neoplasia detection rates based on the procedure order (WATS vs biopsy sampling first), of each procedure separately, and the additional time required for WATS.
RESULTS
One hundred sixty patients (mean age, 63.4 years; 76% men; 95% white) completed the trial. The median circumferential and maximal BE extents were 1.0 cm (interquartile range: .0-5.0) and 4.0 cm (interquartile range, 2.0-8.0), respectively. The diagnostic yield for biopsy sampling alone was as follows: HGD/EAC, 7 (4.4%); low-grade dysplasia (LGD), 28 (17.5%); nondysplastic BE (NDBE), 106 (66.25%); and no BE, 19 (11.9%). The addition of WATS to biopsy sampling yielded an additional 23 cases of HGD/EAC (absolute increase, 14.4%; 95% confidence interval, 7.5%-21.2%). Among these 23 patients, 11 were classified by biopsy sampling as NDBE and 12 as LGD/indefinite for dysplasia (IND); 14 received biopsy sampling first and 9 WATS first (not significant) and most (n = 21; 91.7%) had a prior dysplasia history. WATS added an average of 4.5 minutes to the procedure.
CONCLUSION
Results of this multicenter, prospective, randomized trial demonstrate that the use of WATS in a referral BE population increases the detection of HGD/EAC. (Clinical trial registration number: NCT03008980.).
背景和目的
广域跨上皮取样(WATS)结合计算机辅助三维分析是一种取样技术,它结合了 Barrett 食管(BE)黏膜的研磨刷检,然后通过神经网络分析突出异常外观的细胞。
方法
我们在 16 个医学中心进行了一项针对接受监测的 BE 患者的随机试验。受试者接受活检取样后进行 WATS 或 WATS 后进行活检取样。主要结局是使用 WATS 结合活检取样与单独使用标准组织病理学标准进行活检取样相比,检测高级别异型增生/食管腺癌(HGD/EAC)的检出率。次要目的包括评估根据程序顺序(WATS 与活检取样)检测肿瘤的检出率、单独程序的检出率,以及 WATS 所需的额外时间。
结果
160 名患者(平均年龄 63.4 岁;76%为男性;95%为白人)完成了试验。BE 的中位环形和最大长度分别为 1.0cm(四分位间距:0.0-5.0)和 4.0cm(四分位间距,2.0-8.0)。单独活检取样的诊断率如下:HGD/EAC,7(4.4%);低级别异型增生(LGD),28(17.5%);非异型增生 BE(NDBE),106(66.25%);无 BE,19(11.9%)。WATS 联合活检取样额外检出 23 例 HGD/EAC(绝对增加 14.4%;95%置信区间,7.5%-21.2%)。在这 23 名患者中,11 名患者通过活检取样被分类为 NDBE,12 名患者被分类为 LGD/不确定异型增生(IND);14 名患者先接受活检取样,9 名患者先接受 WATS 取样(无显著差异),大多数(n=21;91.7%)有既往异型增生史。WATS 平均增加了 4.5 分钟的手术时间。
结论
这项多中心、前瞻性、随机试验的结果表明,在转诊 BE 人群中使用 WATS 可增加 HGD/EAC 的检出率。(临床试验注册号:NCT03008980.)