Department of Gastroenterological Surgery, Osaka University, Osaka, Japan.
Endoscopy. 2012 Dec;44(12):1139-48. doi: 10.1055/s-0032-1310093. Epub 2012 Aug 29.
A new overtube system has been developed for steady pressure automatically controlled endoscopy (SPACE) in the gastrointestinal tract. The objectives of this study were to validate the feasibility and safety of SPACE in the esophagus, and to evaluate its potential advantages over conventional (manually insufflating) endoscopy in endoscopic submucosal dissection (ESD).
This was a multicenter preclinical trial using acute porcine models (n = 20). In Experiment 1 (feasibility/safety study), SPACE was attempted in the esophagus with continuous monitoring of cardiopulmonary parameters and intraluminal pressures in the downstream bowel. Different insufflation pressures were tested to optimize the insufflation condition. Each session was video-recorded and scored by blinded reviewers. In Experiment 2 (randomized trial), esophageal ESD was attempted using either SPACE or conventional endoscopy, and results were compared.
In Experiment 1, SPACE was performed safely without intraluminal pressure elevation in the downstream bowel. According to video review, SPACE provided more stable, reproducible, and rapid visualization than conventional endoscopy. The insufflation pressure was optimized at 14 mmHg for esophageal SPACE. In Experiment 2, ESD was completed in all animals. The ESD time was significantly shorter with SPACE compared with conventional endoscopy (1326 vs. 1616 seconds; P = 0.009). Responses to questionnaires showed that 94 % - 100 % of participants considered SPACE to provide improved exposure and more uniform tissue tension than conventional endoscopy. Other data were comparable.
SPACE is feasible, safe, and potentially effective for complicated endoscopic procedures, such as ESD. SPACE improves and standardizes endoscopic exposure and tissue tension. A clinical study is required to further confirm its safety and clinical effectiveness.
一种新型的外套管系统已被开发用于胃肠道的自动控制压力内镜（SPACE）。本研究的目的是验证 SPACE 在食管中的可行性和安全性，并评估其在内镜黏膜下剥离术（ESD）中相对于传统（手动注气）内镜的潜在优势。
这是一项使用急性猪模型的多中心临床前试验（n = 20）。在实验 1（可行性/安全性研究）中，通过连续监测心肺参数和下游肠道内的压力，尝试在食管中使用 SPACE。测试了不同的注气压力以优化注气条件。每次操作均由盲法评审员进行视频记录和评分。在实验 2（随机试验）中，尝试使用 SPACE 或传统内镜进行食管 ESD，并比较结果。
在实验 1 中，SPACE 安全进行，下游肠道内无压力升高。根据视频评估，SPACE 提供了比传统内镜更稳定、更可重复和更快速的可视化效果。优化食管 SPACE 的注气压力为 14 mmHg。在实验 2 中，所有动物均完成 ESD。与传统内镜相比，SPACE 使 ESD 时间显著缩短（1326 秒与 1616 秒；P = 0.009）。问卷调查的结果显示，94%-100%的参与者认为 SPACE 提供了更好的暴露和更均匀的组织张力，优于传统内镜。其他数据无显著差异。
SPACE 对于复杂的内镜手术，如 ESD，是可行、安全且可能有效的。SPACE 改善和标准化了内镜的暴露和组织张力。需要进行临床研究进一步证实其安全性和临床效果。
