Delvaux M, Papanikolaou I S, Fassler I, Pohl H, Voderholzer W, Rösch T, Gay G
Department of Internal Medicine and Digestive Pathology, Hôpitaux de Brabois, CHU de Nancy, France.
Endoscopy. 2008 Jan;40(1):16-22. doi: 10.1055/s-2007-966935. Epub 2007 Dec 5.
The study aim was to compare the diagnostic yield of capsule endoscopy and esophagogastroduodenoscopy (EGD) in patients with suspected esophageal disease. Secondary aims were to assess interobserver variability of capsule endoscopy readings and safety.
In total, 98 patients (53 men, 53 +/- 13 years) with an indication for EGD were included. The patient population was artificially enriched to include two thirds of patients with abnormal esophageal findings at EGD, which was followed by capsule endoscopy. Capsule recordings were blindly read by three endoscopists, one from the center that recruited the patient and two from the other center. Study outcomes were the findings described on EGD and capsule endoscopy, agreement between EGD and capsule endoscopy for findings, quality of the capsule recording, and interobserver agreement for capsule endoscopy quality and findings.
EGD was normal in 34 patients and showed esophageal findings in 62 (esophagitis 28, hiatus hernia 21, varices 21, Barrett's esophagus 11, others 7). Average esophageal transit time of the capsule was 361 +/- 393 seconds. Capsule endoscopy was normal in 36 patients but detected esophagitis in 23, hiatus hernia in 0, varices in 23, Barrett's esophagus in 18, and others in 4. The positive predictive value of capsule endoscopy was 80.0 % and the negative predictive value was 61.1 %. Overall agreement per patient was moderate between EGD and capsule endoscopy for the per-patient (kappa = 0.42) and per-findings (kappa = 0.40) analyses. Interobserver agreement between capsule endoscopy readings was moderate for findings (kappa = 0.39) and quality assessment (kappa = 0.24). No adverse event was observed after either EGD or capsule endoscopy.
In this study, despite artificial prevalence enrichment, capsule endoscopy showed a moderate sensitivity and specificity in the detection of esophageal diseases.
本研究旨在比较胶囊内镜与食管胃十二指肠镜检查（EGD）对疑似食管疾病患者的诊断率。次要目的是评估胶囊内镜读数的观察者间变异性及安全性。
共纳入98例有EGD检查指征的患者（53例男性，年龄53±13岁）。患者群体经人工富集，纳入三分之二EGD检查发现食管异常的患者，随后进行胶囊内镜检查。胶囊记录由三名内镜医师进行盲法解读，一名来自招募患者的中心，另外两名来自另一个中心。研究结果包括EGD和胶囊内镜检查所描述的结果、EGD与胶囊内镜检查结果的一致性、胶囊记录的质量以及胶囊内镜质量和结果的观察者间一致性。
34例患者EGD检查正常，62例有食管病变（食管炎28例、食管裂孔疝21例、静脉曲张21例、巴雷特食管11例、其他7例）。胶囊的平均食管通过时间为361±393秒。36例患者胶囊内镜检查正常，但检测到食管炎23例、食管裂孔疝0例、静脉曲张23例、巴雷特食管18例、其他4例。胶囊内镜的阳性预测值为80.0%，阴性预测值为61.1%。在按患者分析（kappa = 0.42）和按检查结果分析（kappa = 0.40）时，EGD与胶囊内镜检查在每位患者中的总体一致性为中等。胶囊内镜读数在检查结果（kappa = 0.39）和质量评估（kappa = 0.24）方面的观察者间一致性为中等。EGD检查或胶囊内镜检查后均未观察到不良事件。
在本研究中，尽管人工提高了患病率，但胶囊内镜在检测食管疾病方面显示出中等的敏感性和特异性。
