背景:磁辅助胶囊内窥镜检查(MACE)显示了上消化道检查的可行性。为了进一步提高常规MACE的性能,有必要提供质量改进的三维图像。这项临床研究的目的是确定新型三维MACE(3DMACE)用于上消化道和小肠检查的有效性和安全性。
方法:这是一个前瞻性的,单中心,非随机化,东国大学伊尔山医院的序贯检查研究(KCT0007114)。包括接受上消化道内窥镜检查的成年患者。研究方案分两个阶段进行。首先,使用3DMACE进行上消化道检查,并通过常规的胶囊内镜检查方法进行连续小肠检查。两小时后,为了与3DMACE检查进行比较,我们进行了上消化道内窥镜检查.主要结果是胃主要结构的确认(食管胃结合部,贲门/眼底,身体,angle,胃窦,和幽门)。次要结果是食管和十二指肠球部的确认,胃部病变的准确性,完成小肠检查,胃病变的三维图像重建,和安全。
结果:最终纳入了55名患者。3DMACE检查时间为14.84±3.02分钟,上镜检查时间为5.22±2.39分钟。在3DMACE中,六种主要胃结构的确诊率为98.6%,在上消化道镜检查中为100%。在3DMACE期间,在43例患者中发现了胃病变,和40例患者在上内窥镜检查(灵敏度0.97)。获取3DMACE检查的所有病变的3D重建图像。通过3DMACE的连续小肠检查完成了94.5%。3DMACE显示出更好的总体满意度(3DMACE9.55±0.79和上消化道镜检查7.75±2.34,p<0.0001)。在3DMACE检查中没有误吸或明显的不良事件或胶囊滞留。
结论:新型3DMACE系统是比传统MACE更先进的诊断模式。并且可以进行连续的上消化道和小肠检查作为非侵入性和一步测试。它也将成为泛内窥镜检查的桥梁。
BACKGROUND: Magnetically assisted capsule endoscopy (MACE) showed the feasibility for upper gastrointestinal examination. To further enhance the performance of conventional MACE, it is necessary to provide quality-improved and three-dimensional images. The aim of this clinical study was to determine the efficacy and safety of novel three-dimensional MACE (3D MACE) for upper gastrointestinal and small bowel examination at once.
METHODS: This was a prospective, single-center, non-randomized, and sequential examination study (KCT0007114) at Dongguk University Ilsan Hospital. Adult patients who visited for upper endoscopy were included. The study protocol was conducted in two stages. First, upper gastrointestinal examination was performed using 3D MACE, and a continuous small bowel examination was performed by conventional method of capsule endoscopy. Two hours later, an upper endoscopy was performed for comparison with 3D MACE examination. The primary outcome was confirmation of major gastric structures (esophagogastric junction, cardia/fundus, body, angle, antrum, and pylorus). Secondary outcomes were confirmation of esophagus and duodenal bulb, accuracy for gastric lesions, completion of small bowel examination, 3D image reconstruction of gastric lesion, and safety.
RESULTS: Fifty-five patients were finally enrolled. The examination time of 3D MACE was 14.84 ± 3.02 minutes and upper endoscopy was 5.22 ± 2.39 minutes. The confirmation rate of the six major gastric structures was 98.6% in 3D MACE and 100% in upper endoscopy. Gastric lesions were identified in 43 patients during 3D MACE, and 40 patients during upper endoscopy (Sensitivity 0.97). 3D reconstructed images were acquired for all lesions inspected by 3D MACE. The continuous small bowel examination by 3D MACE was completed in 94.5%. 3D MACE showed better overall satisfaction (3D MACE 9.55 ± 0.79 and upper endoscopy 7.75 ± 2.34, p<0.0001). There were no aspiration or significant adverse event or capsule retention in the 3D MACE examination.
CONCLUSIONS: Novel 3D MACE system is more advanced diagnostic modality than the conventional MACE. And it is possible to perform serial upper gastrointestinal and small bowel examination as a non-invasive and one-step test. It would be also served as a bridge to pan-endoscopy.