Mount Sinai Medical Center, New York, New York, USA.
Gastrointest Endosc. 2010 Mar;71(3):551-6. doi: 10.1016/j.gie.2009.09.043. Epub 2009 Dec 16.
Colonoscopy may fail to detect neoplasia located on the proximal sides of haustral folds and flexures. The Third Eye Retroscope (TER) provides a simultaneous retrograde view that complements the forward view of a standard colonoscope.
To evaluate the added benefit for polyp detection during colonoscopy of a retrograde-viewing device.
Open-label, prospective, multicenter study evaluating colonoscopy by using a TER in combination with a standard colonoscope.
Eight U.S. sites, including university medical centers, ambulatory surgery centers, a community hospital, and a physician's office.
A total of 249 patients (age range 55-80 years) presenting for screening or surveillance colonoscopy.
After cecal intubation, the disposable 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.
The number and sizes of lesions (adenomas and all polyps) detected with the standard colonoscope and the number and sizes of lesions found only because they were first detected with the TER.
In the 249 subjects, 257 polyps (including 136 adenomas) were identified with the colonoscope alone. The TER allowed detection of 34 additional polyps (a 13.2% increase; P < .0001) including 15 additional adenomas (an 11.0% increase; P < .0001). For lesions 6 mm or larger, the additional detection rates with the TER for all polyps and for adenomas were 18.2% and 25.0%, respectively. For lesions 10 mm or larger, the additional detection rates with the TER for all polyps and for adenomas were 30.8% and 33.3%, respectively. In 28 (11.2%) individuals, at least 1 additional polyp was found with the TER. In 8 (3.2%) patients, the polyp detected with the TER was the only one found. Every polyp that was detected with the TER was subsequently located with the colonoscope and removed. For all polyps and for adenomas, the additional detection rates for the TER were 9.7%/4.1% in the left colon (the splenic flexure to the rectum) and 16.5%/14.9% in the right colon (the cecum to the transverse colon), respectively.
There was no randomization or comparison with a separate control group.
A retrograde-viewing device revealed areas that were hidden from the forward-viewing colonoscope and allowed detection of 13.2% additional polyps, including 11.0% additional adenomas. Additional detection rates with the TER for adenomas 6 mm or larger and 10 mm or larger were 25.0% and 33.3%, respectively. (
NCT00657371.).
结肠镜检查可能无法检测到位于横襞和弯曲近端侧的肿瘤。第三只眼 Retroscope(TER)提供了一个同时的逆行视图,补充了标准结肠镜的正向视图。
评估在结肠镜检查中使用逆行观察设备对息肉检测的附加益处。
一项开放标签、前瞻性、多中心研究,使用 TER 与标准结肠镜联合评估结肠镜检查。
美国 8 个地点,包括大学医疗中心、门诊手术中心、社区医院和医生办公室。
共 249 名(年龄 55-80 岁)患者,因筛查或监测结肠镜检查就诊。
在盲肠插管后,将一次性 TER 通过结肠镜的器械通道插入。在撤回过程中,通过宽屏监视器同时观察正向和逆行视频图像。
使用标准结肠镜检测到的病变(腺瘤和所有息肉)的数量和大小,以及仅通过 TER 首次检测到的病变的数量和大小。
在 249 名受试者中,单独使用结肠镜检查发现 257 个息肉(包括 136 个腺瘤)。TER 允许检测到 34 个额外的息肉(增加 13.2%;P <.0001),包括 15 个额外的腺瘤(增加 11.0%;P <.0001)。对于 6 毫米或更大的病变,TER 对所有息肉和腺瘤的额外检测率分别为 18.2%和 25.0%。对于 10 毫米或更大的病变,TER 对所有息肉和腺瘤的额外检测率分别为 30.8%和 33.3%。在 28 名(11.2%)患者中,至少有 1 个额外的息肉通过 TER 发现。在 8 名(3.2%)患者中,通过 TER 检测到的息肉是唯一发现的息肉。TER 检测到的每个息肉随后都通过结肠镜找到并切除。对于所有息肉和腺瘤,TER 的额外检测率分别为左半结肠(脾曲至直肠)的 9.7%/4.1%和右半结肠(盲肠至横结肠)的 16.5%/14.9%。
没有随机分组或与单独的对照组进行比较。
逆行观察设备揭示了从前向观察结肠镜检查中隐藏的区域,并允许检测到 13.2%的额外息肉,包括 11.0%的额外腺瘤。TER 对直径 6 毫米或更大和 10 毫米或更大的腺瘤的额外检测率分别为 25.0%和 33.3%。(临床试验注册号:NCT00657371。)