Lewis B S, Eisen G M, Friedman S
New York, NY 10128, USA.
Endoscopy. 2005 Oct;37(10):960-5. doi: 10.1055/s-2005-870353.
Capsule endoscopy is a new tool in the evaluation of the small intestine. To speed evaluation and acceptance of this technology, the manufacturer (Given Imaging Ltd, Yoqneam, Israel) funded several trials. The data from these trials were collected at a central repository using a standardized reporting tool. Presentation of this data to the US Food and Drug Administration (FDA) in July 2003 led to the removal of the adjunctive term with regard to indication for capsule endoscopy, recognizing that the method is of independent importance for evaluating the small bowel. The aim of the present study was to combine the data from several capsule trials to help determine the yield and miss rate of capsule endoscopy for different diseases, compared with alternative diagnostic modalities.
Capsule studies were identified from a master database of funded studies. Studies were included in the pooled analysis if they reported a prospective comparison with another modality for evaluation of the small intestine.
32 studies with a total of 691 patients were found in the master database, of which 24 studies, representing 530 patients, met inclusion criteria and were entered into the pooled analysis. Prior to study entry, patients had undergone a mean of 6.77 diagnostic procedures, without findings. Of these 24 studies, 14 (involving 310 patients) were categorized as "bleeding" studies, and 10 studies (220 patients) as "nonbleeding small-bowel disorders" studies. The comparison procedure was push enteroscopy in 300 patients (in 45 for nonbleeding disorders), small-bowel series in 140 patients (in 125 for non-bleeding disorders), and colonoscopy with ileoscopy in 90 patients (50 for nonbleeding disorders). Overall analysis per patient showed new findings from capsule endoscopy in 50 % of patients; 17 % had new findings from the comparison method; in 22 % there were similar findings; and in 11 % there were no findings. A total of 1349 instances of disease were identified in the 530 examinations. Capsule endoscopy solely detected 87 % of the disease instances, while the comparison method solely detected 13 %. The yield for push enteroscopy alone was 14.8 %, for small-bowel series it was 9.9 %, and for colonoscopy it was 13.2 %. Capsule endoscopy missed 146 disease instances for a miss rate of 10 %; 989 were missed by the comparison methods for a miss rate of 73 %; and 214 were detected by both methods.
Capsule endoscopy is the state of the art method for noninvasive detection of small-bowel disease.
胶囊内镜是评估小肠的一种新工具。为加快该技术的评估与推广，制造商（以色列约克尼姆的Given Imaging Ltd公司）资助了多项试验。这些试验的数据通过标准化报告工具收集于一个中央数据库。2003年7月向美国食品药品监督管理局（FDA）提交的数据促使其取消了关于胶囊内镜适应证的附加说明，因为认识到该方法在评估小肠方面具有独立的重要性。本研究的目的是合并多项胶囊试验的数据，以帮助确定与其他诊断方式相比，胶囊内镜对不同疾病的检出率和漏诊率。
从资助研究的主数据库中识别胶囊研究。如果研究报告了与另一种评估小肠的方式进行前瞻性比较，则纳入汇总分析。
在主数据库中发现32项研究，共691例患者，其中24项研究（代表530例患者）符合纳入标准并进入汇总分析。在研究入组前，患者平均接受了6.77次诊断检查，均未发现异常。在这24项研究中，14项（涉及310例患者）被归类为“出血性”研究，10项研究（220例患者）为“非出血性小肠疾病”研究。比较检查方法为推进式小肠镜检查300例患者（45例用于非出血性疾病），小肠造影140例患者（125例用于非出血性疾病），结肠镜检查联合回肠镜检查90例患者（50例用于非出血性疾病）。每位患者的总体分析显示，50%的患者通过胶囊内镜发现了新的病变；17%的患者通过比较检查方法发现了新病变；22%的患者两种方法有相似发现；11%的患者两种方法均未发现病变。在530次检查中共识别出1349例疾病病例。胶囊内镜单独检测出87%的疾病病例，而比较检查方法单独检测出13%。推进式小肠镜检查的检出率为14.8%，小肠造影为9.9%，结肠镜检查为13.2%。胶囊内镜漏诊146例疾病病例，漏诊率为10%；比较检查方法漏诊989例，漏诊率为73%；两种方法均检测出214例。
胶囊内镜是无创检测小肠疾病的先进方法。
