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自发荧光成像在扁平型肿瘤检测中的疗效:一项多中心随机对照试验(A-FLAT 试验)。

Efficacy of autofluorescence imaging for flat neoplasm detection: a multicenter randomized controlled trial (A-FLAT trial).

机构信息

Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan.

Department of Gastroenterology and Hematology, Hirosaki University Graduate School of Medicine, Japan.

出版信息

Gastrointest Endosc. 2019 Mar;89(3):460-469. doi: 10.1016/j.gie.2018.11.012. Epub 2018 Nov 16.

Abstract

BACKGROUND AND AIMS

Colorectal flat (nonpolypoid) lesions can be overlooked during colonoscopy. This study evaluated the efficacy of updated autofluorescence imaging (AFI) for detecting colorectal flat neoplasms.

METHODS

This was a prospective, multicenter, randomized controlled trial in 9 Japanese tertiary institutions. Patients undergoing colonoscopy because of positive fecal immunochemical tests, surveillance after polypectomy, or investigation of minor symptoms were enrolled and randomly assigned to either the white-light imaging (WLI) or the AFI group. Primary outcome measurement was number of flat neoplasms per patient.

RESULTS

From November 2015 to June 2017, 817 patients were enrolled. After excluding 15 patients, 802 were finally analyzed (404, WLI; 398, AFI). Patients' backgrounds (sex, age, indication of colonoscopy, experience of endoscopists) and quality of colonoscopy (bowel preparation, sedative use, cecal insertion rate, insertion and withdrawal time) were not different between groups. Number of flat neoplasms in each patient was significantly higher in the AFI than in the WLI group (.87 [95% confidence interval [CI], .78-.97] vs .53 [95% CI, .46-.61]), whereas overall and polypoid neoplasm detection was not significantly different between the groups (1.33 [95% CI, 1.22-1.45] vs 1.14 [95% CI, 1.03-1.24], .46 [95% CI, .40-.53] vs .60 [95% CI, .53-.68]). Flat neoplasms were more frequently detected in the right-sided colon with AFI (.61 [95% CI, .54-.70] vs .30 [95% CI, .25-.36]) but not in the left-sided colon and rectum (.26 [95% CI, .21-.32] vs .23 [95% CI, .19-.28]).

CONCLUSIONS

Updated AFI improves the detection of flat colorectal neoplasms in the right-sided colon compared with WLI. (Clinical trial registration number: UMIN000019355.).

摘要

背景与目的

结肠镜检查时可能会忽略结直肠扁平(非息肉样)病变。本研究评估了更新的自发荧光成像(AFI)检测结直肠扁平肿瘤的效果。

方法

这是一项在日本 9 家三级医疗机构进行的前瞻性、多中心、随机对照试验。因粪便免疫化学检测阳性、息肉切除后监测或轻微症状检查而接受结肠镜检查的患者被纳入并随机分配到白光成像(WLI)或 AFI 组。主要测量指标为每位患者的扁平肿瘤数量。

结果

从 2015 年 11 月至 2017 年 6 月,共纳入 817 例患者。排除 15 例患者后,最终分析了 802 例患者(WLI 组 404 例,AFI 组 398 例)。两组患者的背景(性别、年龄、结肠镜检查指征、内镜医师经验)和结肠镜检查质量(肠道准备、镇静剂使用、盲肠插入率、插入和退出时间)无差异。AFI 组患者的扁平肿瘤数量明显多于 WLI 组(0.87 [95%置信区间(CI),0.78-0.97] 与 0.53 [95% CI,0.46-0.61]),而两组的总体和息肉样肿瘤检出率无显著差异(1.33 [95% CI,1.22-1.45] 与 1.14 [95% CI,1.03-1.24],0.46 [95% CI,0.40-0.53] 与 0.60 [95% CI,0.53-0.68])。AFI 可更频繁地检测到右半结肠的扁平肿瘤(0.61 [95% CI,0.54-0.70] 与 0.30 [95% CI,0.25-0.36]),而不是左半结肠和直肠(0.26 [95% CI,0.21-0.32] 与 0.23 [95% CI,0.19-0.28])。

结论

与 WLI 相比,更新的 AFI 可提高右半结直肠扁平肿瘤的检出率。(临床试验注册号:UMIN000019355。)

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