Division of Gastroenterology, City of Hope National Medical Center, Duarte, California.
Division of Gastroenterology, University of California, San Francisco, San Francisco, California.
Clin Gastroenterol Hepatol. 2019 Mar;17(4):701-708.e1. doi: 10.1016/j.cgh.2018.06.024. Epub 2018 Jun 20.
BACKGROUND & AIMS: I-scan is an electronic chromoendoscopy technology that improves resolution of epithelial and mucosal surfaces and vessels. We performed a randomized controlled trial to compare detection of adenomas by i-scan vs standard high-definition white-light (HDWL) colonoscopy.
From February 1 through December 31, 2017, 740 outpatients (50-75 years old) undergoing screening and surveillance for colorectal neoplasia were randomly assigned to groups that received colonoscopies with i-scan 1 (surface and contrast enhancement) or HDWL. When lesions and polyps were detected, endoscopists could switch between i-scan 1 and HDWL imaging to confirm their finding; polyps were collected and analyzed by histology. The primary outcome was adenoma detection rate (ADR, proportion of subjects with at least 1 adenoma of any size); secondary outcomes included detection of sessile serrated polyps and neoplasias, along with location, size, and morphology of polyps. We performed intent to treat and per-protocol analyses (on 357 patients evaluated by i-scan and 358 evaluated by HDWL colonoscopy) to assess the primary and secondary outcomes.
There were no differences in baseline characteristics between the groups. In the intent to treat analysis, the ADR was significantly higher in the i-scan 1 group (47.2%) than in the HDWL colonoscopy group (37.7%) (P = .01). In the per-protocol analysis, the ADR in the i-scan 1 group (47.6%) was also significantly higher than in the HDWL group (37.2%) (P = .005), but this effect was not consistent among all endoscopists. There was no difference between groups in detection of sessile serrated polyps. However, the rate of neoplasia detection was significantly higher in the i-scan 1 group (56.4%) than in the than the HDWL group (46.1%) (P = .005). In secondary analyses, the increase in ADR was associated with improved detection of diminutive flat adenomas in the right colon.
In a prospective randomized trial, higher proportions of patients with adenomas were identified in a group that underwent colonoscopy with i-scan 1 than in a group evaluated by HDWL colonoscopy. This effect was mainly due to improved detection of diminutive, flat right sided adenomas. I-scan 1 technology may benefit some endoscopists. ClinicalTrials.gov no: NCT02811419.
I-scan 是一种电子染色内镜技术,可提高上皮和黏膜表面及血管的分辨率。我们进行了一项随机对照试验,比较 i-scan 与标准高清白光(HDWL)结肠镜检查对腺瘤的检测。
2017 年 2 月 1 日至 12 月 31 日,740 名接受结直肠肿瘤筛查和监测的门诊患者(50-75 岁)被随机分配至接受 i-scan 1(表面增强和对比增强)或 HDWL 结肠镜检查的组。当发现病变和息肉时,内镜医生可以在 i-scan 1 和 HDWL 成像之间切换以确认其发现;息肉通过组织学进行收集和分析。主要结局是腺瘤检出率(ADR,至少检出 1 个任何大小腺瘤的受试者比例);次要结局包括检测出无蒂锯齿状息肉和肿瘤,以及息肉的位置、大小和形态。我们进行了意向治疗和方案分析(对 357 名接受 i-scan 评估的患者和 358 名接受 HDWL 结肠镜检查的患者),以评估主要和次要结局。
两组间基线特征无差异。意向治疗分析显示,i-scan 1 组 ADR(47.2%)显著高于 HDWL 结肠镜组(37.7%)(P =.01)。方案分析中,i-scan 1 组的 ADR(47.6%)也显著高于 HDWL 组(37.2%)(P =.005),但这种效果并非所有内镜医生都一致。两组间无蒂锯齿状息肉的检出率无差异。然而,i-scan 1 组的肿瘤检出率(56.4%)显著高于 HDWL 组(46.1%)(P =.005)。在次要分析中,ADR 的增加与右半结肠微小扁平腺瘤的检出改善有关。
在一项前瞻性随机试验中,与接受 HDWL 结肠镜检查的患者相比,接受 i-scan 1 结肠镜检查的患者中更多比例的患者被发现患有腺瘤。这种效果主要是由于对微小的、平坦的右半结肠腺瘤的检测改善所致。I-scan 1 技术可能对一些内镜医生有益。临床试验.gov 编号:NCT02811419。