BACKGROUND AND AIMS Compared with conventional endoscopy, magnetically controlled capsule gastroscopy (MCCG) can be further optimized in gastric examination time and complete visualization of upper GI (UGI) mucosa. The second-generation MCCG (MCCG-2) was developed with higher image resolution and adaptive frame rate, and we aimed to evaluate its clinical availability for UGI examination in this study. METHODS Consecutive patients undergoing MCCG examination between May to June 2019 were prospectively enrolled and randomized to swallow the first-generation MCCG (MCCG-1) or MCCG-2 in a 1:1 ratio. The main outcomes included visualization of the esophagus and duodenum, operation-related parameters, image quality, maneuverability, detection of lesions, and safety evaluation. RESULTS Eighty patients were enrolled. In the MCCG-2 group, frames captured for esophageal mucosa and Z-line were 171.00 and 2.00, significantly increased from those in the MCCG-1 group (97.00 [P = .002] and .00 [P = .028], respectively). The gastric examination time was shortened from 7.78 ± .97 minutes to 5.27 ± .74 minutes (P < .001), with the total running time of the capsule extended from 702.83 minutes to 1001.99 minutes (P < .001). MCCG-2 also greatly improved the image quality (P < .001) and maneuverability (P < .01). No statistical difference existed in the detection of lesions between the 2 groups, and no adverse events occurred. CONCLUSIONS MCCG-2 showed better performance in mucosal visualization, examination duration, and maneuverability, making better diagnosis of UGI diseases a possibility. (Clinical trial registration number: NCT03977935.).

中文翻译：

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具有改善的图像分辨率和帧频的第二代磁控胶囊胃镜检查：随机对照临床试验（带视频）。

背景与目的与常规内窥镜检查相比，磁控胶囊胃镜检查（MCCG）可以进一步优化胃部检查时间并完全可视化上GI（UGI）粘膜。开发了具有更高图像分辨率和自适应帧频的第二代MCCG（MCCG-2），我们旨在评估其在本研究中用于UGI检查的临床可用性。方法前瞻性纳入2019年5月至2019年6月接受MCCG检查的连续患者，并随机以1：1的比例吞咽第一代MCCG（MCCG-1）或MCCG-2。主要结果包括食道和十二指肠的可视化，与手术相关的参数，图像质量，可操作性，病变的检测以及安全性评估。结果招募了80名患者。在MCCG-2组中，食管粘膜和Z线捕获的帧分别为171.00和2.00，比MCCG-1组的捕获帧显着增加（分别为97.00 [P = .002]和.00 [P = .028]）。胃检查时间从7.78±.97分钟缩短至5.27±.74分钟（P <.001），胶囊的总运行时间从702.83分钟延长至1001.99分钟（P <.001）。MCCG-2还极大地改善了图像质量（P <.001）和可操作性（P <.01）。两组间病变的检测无统计学差异，无不良事件发生。结论MCCG-2在黏膜可视化，检查持续时间和可操作性方面表现出更好的性能，从而有可能更好地诊断UGI疾病。（临床试验注册号：NCT03977935。）。