Gralnek Ian M, Suissa Alain, Domanov Sveta
Department of Gastroenterology, Rambam Health Care Campus, Haifa, Israel.
Endoscopy Unit, Elisha Hospital, Haifa, Israel.
Endoscopy. 2014 Oct;46(10):883-7. doi: 10.1055/s-0034-1377968. Epub 2014 Sep 16.
Although colonoscopy is the gold standard for detecting colorectal cancer (CRC), adenomas and cancers are missed. We aimed to establish the safety and feasibility of use of a novel balloon-colonoscope.
Patients (40 - 75 years) referred for CRC screening, polyp surveillance, or diagnostic evaluation were enrolled in a prospective pilot cohort study whose primary endpoint was device safety. Additional endpoints included success of and time to cecal intubation, withdrawal and total procedure times, polyp detection rate (PDR), adenoma detection rate (ADR), and success of polypectomies.
Among 50 patients (mean age 59.0 years, 27 women [54 %]), three were excluded (inadequate colon preparation, technical problem, abdominal hernia) and 47 were analyzed. Two patients experienced minor adverse events (diarrhea, abdominal pain). Cecal intubation rate was 47 /47 (100 %). Mean times, to reach cecum, withdrawal, and total procedure, were 4.3, 7.4, and 16.5 minutes, respectively. We identified 44 polyps (all successfully removed) in 25 /47 patients (PDR 53.2 %), 35 polyps (79.5 %) were 1 - 5 mm, 4 (9.1 %) 6 - 9 mm, and 5 (11.4 %) ≥ 10 mm. Of 44 polyps, 36 (81.8 %) were "adenomas"; 21/47 patients had ≥ 1 adenoma (ADR 44.7 %).
The NaviAid G-EYE balloon-colonoscope appears safe and feasible to use. Comparative human studies are underway.Clinicaltrials.gov identifier: NCT01749722.
尽管结肠镜检查是检测结直肠癌（CRC）的金标准，但仍会漏诊腺瘤和癌症。我们旨在确定新型球囊结肠镜使用的安全性和可行性。
将因CRC筛查、息肉监测或诊断评估而转诊的40 - 75岁患者纳入一项前瞻性试点队列研究，其主要终点是设备安全性。其他终点包括盲肠插管的成功率和时间、退镜时间和总操作时间、息肉检出率（PDR）、腺瘤检出率（ADR）以及息肉切除术的成功率。
50例患者（平均年龄59.0岁，27例女性[54%]）中，3例被排除（结肠准备不充分、技术问题、腹疝），对47例进行了分析。2例患者出现轻微不良事件（腹泻、腹痛）。盲肠插管率为47/47（100%）。到达盲肠、退镜和总操作的平均时间分别为4.3分钟、7.4分钟和16.5分钟。我们在25/47例患者中发现了44个息肉（均成功切除）（PDR为53.2%），35个息肉（79.5%）为1 - 5毫米，4个（9.1%）为6 - 9毫米，5个（11.4%）≥10毫米。在44个息肉中，36个（81.8%）为“腺瘤”；21/47例患者有≥1个腺瘤（ADR为44.7%）。
NaviAid G-EYE球囊结肠镜使用起来似乎安全可行。正在进行比较性人体研究。Clinicaltrials.gov标识符：NCT01749722。
