自体荧光内镜在巴雷特食管监测中的应用:一项关于诊断效能的多中心随机试验

Autofluorescence endoscopy in surveillance of Barrett's esophagus: a multicenter randomized trial on diagnostic efficacy.

作者信息

Borovicka J, Fischer J, Neuweiler J, Netzer P, Gschossmann J, Ehmann T, Bauerfeind P, Dorta G, Zürcher U, Binek J, Meyenberger C

机构信息

Division of Gastroenterology/Hepatology, Dept. of Internal Medicine, Cantonal Hospital, St. Gallen, Switzerland.

出版信息

Endoscopy. 2006 Sep;38(9):867-72. doi: 10.1055/s-2006-944726.

Abstract

BACKGROUND AND STUDY AIMS

The reference surveillance method in patients with Barrett's esophagus is careful endoscopic observation, with targeted as well as random four-quadrant biopsies. Autofluorescence endoscopy (AFE) may make it easier to locate neoplasia. The aim of this study was to elucidate the diagnostic accuracy of surveillance with AFE-guided plus four-quadrant biopsies in comparison with the conventional approach.

PATIENTS AND METHODS

A total of 187 of 200 consecutive Barrett's esophagus patients who were initially enrolled (73 % male, mean age 67 years, mean Barrett's segment length 4.6 cm), who underwent endoscopy for Barrett's esophagus in four study centers, were randomly assigned to undergo either AFE-targeted biopsy followed by four-quadrant biopsies or conventional endoscopic surveillance, also including four-quadrant biopsies (study phase 1). After exclusion of patients with early cancer or high-grade dysplasia, who underwent endoscopic or surgical treatment, as well as those who declined to participate in phase 2 of the study, 130 patients remained. These patients were examined again with the alternative method after a mean of 10 weeks, using the same methods described. The main study parameter was the detection of early cancer/adenocarcinoma or high-grade dysplasia (HGD), comparing both approaches in study phase 1; the secondary study aim in phase 2 was to assess the additional value of the AFE-guided approach after conventional surveillance, and vice versa. Test accuracy measures were derived from study phase 1.

RESULTS

In study phase 1, the AFE and conventional approaches yielded adenocarcinoma/HGD rates of 12 % and 5.3 %, respectively, on a per-patient basis. With AFE, four previously unrecognized adenocarcinoma/HGD lesions were identified (4.3 % of the patients); with the conventional approach, one new lesion (1.1 %) was identified. Of the 19 adenocarcinoma/HGD lesions detected during AFE endoscopy in study phase 1, eight were visualized, while 11 were only detected using untargeted four-quadrant biopsies (sensitivity 42 %). Of the 766 biopsies classified at histology as being nonneoplastic, 58 appeared suspicious (specificity 92 %, positive predictive value 12 %, negative predictive value 98.5 %). In study phase 2, AFE detected two further lesions in addition to the initial alternative approach in 3.2 % of cases, in comparison with one lesion with conventional endoscopy (1.7 %).

CONCLUSIONS

In this referral Barrett's esophagus population with a higher prevalence of neoplastic lesions, the AFE-guided approach improved the diagnostic yield for neoplasia in comparison with the conventional approach using four-quadrant biopsies. However, AFE alone was not suitable for replacing the standard four-quadrant biopsy protocol.

摘要

背景与研究目的

巴雷特食管患者的参考监测方法是仔细的内镜观察,并进行靶向及随机四象限活检。自体荧光内镜检查(AFE)可能使肿瘤定位更容易。本研究的目的是阐明与传统方法相比,AFE引导下联合四象限活检监测的诊断准确性。

患者与方法

在四个研究中心,对最初纳入的200例连续巴雷特食管患者中的187例(73%为男性,平均年龄67岁,平均巴雷特段长度4.6 cm)进行随机分组,一组先进行AFE靶向活检,随后进行四象限活检;另一组进行传统内镜监测,同样包括四象限活检(研究阶段1)。排除接受内镜或手术治疗的早期癌症或高级别异型增生患者以及拒绝参与研究第2阶段的患者后,剩余130例患者。这些患者在平均10周后,使用相同方法采用另一种方法再次进行检查。主要研究参数是早期癌症/腺癌或高级别异型增生(HGD)的检测,在研究阶段1比较两种方法;第2阶段的次要研究目的是评估传统监测后AFE引导方法的附加价值,反之亦然。检验准确性指标来自研究阶段1。

结果

在研究阶段1,基于患者个体,AFE和传统方法的腺癌/HGD发生率分别为12%和5.3%。采用AFE时,发现了4个先前未识别的腺癌/HGD病变(占患者的4.3%);采用传统方法时,发现了1个新病变(占1.1%)。在研究阶段1的AFE内镜检查中检测到的19个腺癌/HGD病变中,8个可见,而11个仅通过非靶向四象限活检检测到(敏感性42%)。在组织学上分类为非肿瘤性的766次活检中,58次看似可疑(特异性92%,阳性预测值12%,阴性预测值98.5%)。在研究阶段2,与传统内镜检查发现1个病变(1.7%)相比,AFE在3.2%的病例中除最初的另一种方法外又检测到2个病变。

结论

在这个肿瘤性病变患病率较高的转诊巴雷特食管人群中,与采用四象限活检的传统方法相比,AFE引导方法提高了肿瘤的诊断率。然而,单独的AFE并不适合替代标准的四象限活检方案。

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