目标:许多胃肠道(GI)疾病和癌前病变通常无症状地存在,导致延迟患者诊断和治疗干预。本研究旨在开发一种新型的电缆传输磁控胶囊内窥镜(CT-MCCE)系统,用于检测胃肠道疾病,并通过临床试验评估其安全性和可行性。
方法:这种前瞻性,多中心,试验比较了2022年10月至2023年5月期间18-75岁上消化道疾病患者的CT-MCCE和常规胃镜检查.主要终点包括敏感性评估,特异性,阳性预测值(PPV),和阴性预测值(NPV)在食道局灶性病变的检测,胃,和十二指肠球使用CT-MCCE。
结果:共有180人(平均年龄:43.1岁,52.22%的女性)从中国的三家医院招募。CT-MCCE检出食管病变的敏感性为97.22%,100%特异性,PPV为100%,净现值为98.18%,和98.89%的精度。CT-MCCE检测全胃胃局灶性病变的敏感度为96.81%,98.84%特异性,PPV为98.91%,净现值为96.59%,和97.78%的精度。CT-MCCE以100%的灵敏度检测到十二指肠球部的病变,100%特异性,PPV为100%,净现值为100%,100%的准确性。CT-MCCE和EGD在上消化道的清洁度和上消化道粘膜的可见度方面没有显着差异。然而,CT-MCCE的不适发生率低于EGD(P<0.001)。
结论:在完成上消化道检查和病变检测方面,CT-MCCE的诊断性能与EGD相当。此外,观察到CT-MCCE在检测上消化道疾病方面的耐受性提高,未观察到任何不良事件.
OBJECTIVE: Many gastrointestinal (GI) disorders and precancerous conditions often present asymptomatically, leading to delayed patient diagnoses and treatment interventions. This study aimed to develop a novel cable-transmission magnetically controlled capsule endoscopy (CT-MCCE) system for detecting GI diseases and assess its safety and feasibility through clinical trials.
METHODS: This prospective, multicenter, trial compared CT-MCCE with conventional gastroscopy in patients aged 18-75 years with upper GI diseases between October 2022 and May 2023. The primary endpoints included the evaluation of sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) in the detection of focal lesions within the esophagus, stomach, and duodenal bulb using CT-MCCE.
RESULTS: A total of 180 individuals (mean age: 43.1 years, 52.22% female) were recruited from three hospitals in China. CT-MCCE detected lesions in esophagus with 97.22% sensitivity, 100% specificity, a PPV of 100%, a NPV of 98.18%, and 98.89% accuracy. CT-MCCE detected gastric focal lesions in the whole stomach with 96.81% sensitivity, 98.84% specificity, a PPV of 98.91%, a NPV of 96.59%, and 97.78% accuracy. CT-MCCE detected lesions in the duodenal bulb with 100% sensitivity, 100% specificity, a PPV of 100%, a NPV of 100%, and 100% accuracy. There were no significant differences between CT-MCCE and EGD regarding the cleanliness of the upper GI tract and visibility of the upper GI mucosa. However, CT-MCCE was associated with a lower incidence of discomfort than EGD (P<0.001).
CONCLUSIONS: The diagnostic performance of CT-MCCE is comparable to that of EGD in the completion of upper GI tract examinations and lesion detection. Furthermore, the improved tolerance of CT-MCCE in detecting upper GI diseases was noted without any observed adverse events.