Multicentre randomised controlled trial on virtual chromoendoscopy in the detection of neoplasia during colitis surveillance high-definition colonoscopy (the VIRTUOSO trial)

一项关于虚拟染色内镜在结肠炎监测高清结肠镜检查中检测肿瘤的多中心随机对照试验(VIRTUOSO 试验)

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Abstract

BACKGROUND: Longstanding colonic IBD increases the risk of developing colorectal cancer. The utility of chromoendoscopy with standard-definition white light technology has been established. However, the use of high-definition virtual chromoendoscopy (HDV) in colitis surveillance remains undefined. OBJECTIVE: To compare the performance of HDV (i-scan OE mode 2) with high-definition white light (HDWL) for detection of neoplasia in patients with IBD undergoing surveillance colonoscopy. Additionally, we assessed the utility of protocol-guided quadrantic non-targeted biopsies. DESIGN: A multioperator randomised controlled trial was carried out in two centres in the UK. Total of 188 patients (101 men, mean age 54) with longstanding ulcerative or Crohn's colitis were randomised, prior to starting the surveillance colonoscopy, to using either HDV (n=94) or HDWL (n=94) on withdrawal. Targeted and quadrantic non-targeted biopsies were taken in both arms per-randomisation protocol. The primary outcome was the difference in neoplasia detection rate (NDR) between HDV and HDWL. RESULTS: There was no significant difference between HDWL and HDV for neoplasia detection. The NDR was not significantly different for HDWL (24.2%) and HDV (14.9%) (p=0.14). All intraepithelial neoplasia (IEN) detected contained low-grade dysplasia only. A total of 6751 non-targeted biopsies detected one IEN only. The withdrawal time was similar in both arms of the study; median of 24 min (HDWL) versus 25.5 min (HDV). CONCLUSION: HDV and HDWL did not differ significantly in the detection of neoplasia. Almost all neoplasia were detected on targeted biopsy or resection. Quadrantic non-targeted biopsies have negligible additional gain. TRIAL REGISTRATION NUMBER: Clinical Trial.gov ID NCT02822352.

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