Yamamoto Hironori, Yano Tomonori, Ohmiya Naoki, Tanaka Shu, Tanaka Shinji, Endo Yutaka, Matsuda Tomoki, Matsui Toshiyuki, Iida Mitsuo, Sugano Kentaro
Division of Gastroenterology, Department of Medicine, Jichi Medical University, Shimotsuke, Japan.
Dig Endosc. 2015 Mar;27(3):331-7. doi: 10.1111/den.12378. Epub 2014 Oct 13.
Double-balloon endoscopy (DBE) has enabled direct, detailed examination of the entire small bowel with interventional capabilities. Although its usefulness is recognized, efficacy and safety have not been extensively evaluated by prospective multicenter studies. To evaluate the efficacy and safety of DBE carried out by expert and non-expert endoscopists, a prospective, multicenter study was conducted in five university hospitals and a general hospital in Japan.
A total of 120 patients who underwent 179 procedures were enrolled in the study. Experts carried out 129 procedures and non-experts carried out 50 procedures. Primary and secondary end points were evaluation of safety, the rate of achievement of procedural objectives, namely, identification of a new lesion, detailed examination to establish a therapeutic strategy, or exclusion of significant lesions by total enteroscopy, and rate of successful examination of the entire small bowel and evaluation of safety.
Overall rate of achievement of procedural objectives was 82.5% (99/120). Overall success rate for examination of the entire small bowel was 70.8% (34/48). Incidence of adverse events was 1.1% (a mucosal injury and an episode of pyrexia in two of 179 examinations). No severe adverse events were encountered. There were no significant differences in any of the outcome measures comparing expert and non-expert operators.
DBE is effective and safe for patients with suspected small bowel diseases, and can be safely carried out even by a non-expert under the supervision of an expert, following a simple training program.
双气囊小肠镜检查（DBE）能够对整个小肠进行直接、详细的检查，并具备介入能力。尽管其效用已得到认可，但前瞻性多中心研究尚未对其疗效和安全性进行广泛评估。为评估由专家和非专家内镜医师进行的DBE的疗效和安全性，在日本的五所大学医院和一所综合医院开展了一项前瞻性多中心研究。
共有120例患者接受了179例手术，纳入本研究。专家进行了129例手术，非专家进行了50例手术。主要和次要终点是安全性评估、手术目标达成率，即识别新病变、进行详细检查以制定治疗策略或通过全小肠镜检查排除重大病变，以及全小肠检查成功率和安全性评估。
手术目标总体达成率为82.5%（99/120）。全小肠检查总体成功率为70.8%（34/48）。不良事件发生率为1.1%（179例检查中有2例出现黏膜损伤和发热）。未遇到严重不良事件。在比较专家和非专家操作者的任何一项结局指标上均无显著差异。
DBE对疑似小肠疾病患者有效且安全，即使是非专家在专家监督下，经过简单培训程序后也可安全进行。
