Baylor University Medical Center, Dallas, TX 75246, USA.
Gastrointest Endosc. 2010 Mar;71(3):542-50. doi: 10.1016/j.gie.2009.12.021.
Colonoscopy has been adopted as the preferred method to screen for colorectal neoplasia in the United States. However, lesions can be missed because of numerous factors, including location on the proximal aspect of folds or flexures, where they may be difficult to detect with the forward-viewing colonoscope. The Third Eye Retroscope (TER) is a disposable device that is passed through the instrument channel of a standard colonoscope to provide a retrograde view that complements the forward view of the colonoscope during withdrawal.
To evaluate whether experience with the TER affects polyp detection rates and procedure times in experienced endoscopists who had not previously used the equipment.
DESIGN, SETTING, PATIENTS: This was an open-label, prospective, multicenter study at 9 U.S. sites, involving 298 patients presenting for colonoscopy, evaluating the use of the TER in combination with a standard colonoscope.
After cecal intubation, the TER was inserted through the instrument channel of the colonoscope. During withdrawal, the forward and retrograde video images were observed simultaneously on a wide-screen monitor.
Primary outcome measures were the number and size of adenomas and all polyps detected with the standard colonoscope and with the colonoscope combined with the TER. Secondary outcome measures were withdrawal phase time and total procedure time. Each endoscopist examined 20 subjects, divided into quartiles according to the order of their procedures, and results were compared among quartiles.
Overall, 182 polyps were detected with the colonoscope and 27 additional polyps with the TER, a 14.8% increase (P < .001). A total of 100 adenomas were detected with the colonoscope and 16 more with the TER, a 16.0% increase (P < .001). For procedures performed after each endoscopist had completed 15 procedures while using the TER, the mean additional detection rates with the TER were 17.0% for all polyps (P < .001) and 25.0% for adenomas (P < .001). For lesions 6 mm or larger, the overall additional detection rates with the TER for all polyps and for adenomas were 23.2% and 24.3%, respectively. For lesions 10 mm or larger, the overall additional detection rates with the TER for all polyps and for adenomas were 22.6% and 19.0%, respectively. The mean withdrawal times in the first and fourth quartiles were 10.6 and 9.2 minutes, respectively (P = .044).
There was no randomization or separate control group. The endoscopists judged whether each lesion could have been detected with the colonscope alone by using their standard technique.
Polyp detection rates improved significantly with the TER, especially after 15 procedures, when the mean additional detection rate for adenomas was 25.0%. Additional detection rates with the TER for medium-size and large adenomas were greater than for smaller lesions. These results suggest that, compared with a colonoscope alone, a retrograde-viewing device can increase detection rates for clinically significant adenomas without detriment to procedure time or procedure complications. (
NCT00969124.).
结肠镜检查已被采纳为美国筛查结直肠肿瘤的首选方法。然而,由于许多因素,包括位于褶皱或弯曲的近端,可能难以用前视结肠镜检测到,因此可能会遗漏病变。第三只眼 retroscope(TER)是一种一次性设备,可通过标准结肠镜的器械通道传递,提供逆行视图,在退出时补充结肠镜的前视视图。
评估在未使用过该设备的经验丰富的内镜医生中,使用 TER 是否会影响息肉检测率和手术时间。
设计、地点、患者:这是一项在美国 9 个地点进行的开放标签、前瞻性、多中心研究,涉及 298 名接受结肠镜检查的患者,评估了 TER 与标准结肠镜联合使用的情况。
在盲肠插管后,将 TER 通过结肠镜的器械通道插入。在退出过程中,同时在宽屏监视器上观察前视和逆行视频图像。
主要观察指标是标准结肠镜和结肠镜联合 TER 检测到的腺瘤和所有息肉的数量和大小。次要观察指标是退出阶段时间和总手术时间。每位内镜医生检查 20 例患者,根据操作顺序分为四组,比较四组之间的结果。
总共用结肠镜检测到 182 个息肉,用 TER 检测到 27 个额外的息肉,增加了 14.8%(P <.001)。用结肠镜检测到 100 个腺瘤,用 TER 检测到 16 个腺瘤,增加了 16.0%(P <.001)。对于每个内镜医生在使用 TER 完成 15 例操作后进行的操作,使用 TER 的平均额外检测率为所有息肉的 17.0%(P <.001),腺瘤的 25.0%(P <.001)。对于 6 毫米或更大的病变,TER 对所有息肉和腺瘤的总体额外检测率分别为 23.2%和 24.3%。对于 10 毫米或更大的病变,TER 对所有息肉和腺瘤的总体额外检测率分别为 22.6%和 19.0%。第一和第四四分位数的平均退出时间分别为 10.6 和 9.2 分钟(P =.044)。
没有随机分组或单独的对照组。内镜医生使用他们的标准技术判断每个病变是否可以仅用结肠镜检测到。
TER 的息肉检测率显著提高,尤其是在进行 15 次操作后,此时腺瘤的平均额外检测率为 25.0%。TER 对中大型腺瘤的额外检测率高于对较小病变的检测率。这些结果表明,与单独使用结肠镜相比,逆行观察设备可以在不损害手术时间或手术并发症的情况下,提高对临床显著腺瘤的检测率。(临床试验注册号:NCT00969124.)。