Triadafilopoulos G, Li J
Division of Gastroenterology and Hepatology, Stanford University, Stanford, California 94305-5187, USA.
Endoscopy. 2008 Jun;40(6):478-82. doi: 10.1055/s-2007-995811.
Routine colorectal cancer screening, utilizing optical colonoscopy, has been shown to reduce the incidence and mortality rate of colorectal cancer. Despite its prevalence as the "gold standard" for neoplasia detection, the quality of colonoscopy screening is hindered by missed, undiagnosed lesions that may go undetected when located on the proximal aspect of haustral folds, rectal valves, the ileocecal valve, and/or flexures. The aim of this phase I feasibility trial is to assess the safety and efficacy of a new retrograde auxiliary imaging device, Third Eye Retroscope (Avantis Medical Systems, Inc., Sunnyvale, California, USA), used with optical colonoscopy to improve diagnostic yield.
A total of 29 consecutive patients were enrolled in this phase I single-institution prospective series. Primary efficacy endpoint was identification of polyps in the retrograde image that were not identified in the antegrade image during colonoscope withdrawal.
Of the 29 patients enrolled, 24 patients were treated and 34 out of a total of 38 polyps (classified as either adenoma or hyperplasia) were identified in the antegrade image. An additional four polyps, three hyperplastic and one adenoma, were identified in the retrograde image, and were detected on the proximal aspect of haustral folds during the colonoscope withdrawal, resulting in an 11.8% increase in diagnostic yield. No adverse events were encountered during the study.
A retrograde auxiliary imaging device used in conjunction with a standard optical colonoscope proved to be safe, technically feasible, and clinically promising. A phase II multi-institutional study is currently underway to further evaluate this device.
采用光学结肠镜进行常规结直肠癌筛查已被证明可降低结直肠癌的发病率和死亡率。尽管结肠镜检查作为肿瘤检测的“金标准”普遍应用，但结肠镜筛查的质量受到漏诊病变的阻碍，当病变位于袋状皱襞近端、直肠瓣、回盲瓣和/或弯曲处时可能未被发现。这项I期可行性试验的目的是评估一种新型逆行辅助成像设备——第三眼逆行内镜（美国加利福尼亚州桑尼维尔市Avantis医疗系统公司）与光学结肠镜联合使用时的安全性和有效性，以提高诊断率。
本I期单机构前瞻性系列研究共纳入29例连续患者。主要疗效终点是在结肠镜退出过程中，逆行图像中发现而顺行图像中未发现的息肉。
在纳入的29例患者中，24例接受了治疗，在顺行图像中总共识别出38个息肉（分类为腺瘤或增生）中的34个。在逆行图像中又识别出另外4个息肉，3个增生性息肉和1个腺瘤，在结肠镜退出过程中发现它们位于袋状皱襞近端，诊断率提高了11.8%。研究期间未发生不良事件。
与标准光学结肠镜联合使用的逆行辅助成像设备被证明是安全的、技术上可行的且具有临床应用前景。目前正在进行一项II期多机构研究以进一步评估该设备。
