Kato Motohiko, Nakajima Kiyokazu, Yamada Takuya, Hirota Masashi, Miyazaki Yasuaki, Yamasaki Makoto, Nishida Tsutomu, Mori Masaki, Doki Yuichiro, Tsujii Masahiko, Takehara Tetsuo
Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan.
Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
Endoscopy. 2014 Aug;46(8):680-4. doi: 10.1055/s-0034-1365465. Epub 2014 Apr 25.
Steady pressure automatically controlled endoscopy (SPACE) is a new insufflation system that provides constant carbon dioxide (CO2) insufflation pressure during prolonged procedures. The system consists of an overtube, a surgical insufflator, and a newly developed leak-proof valve. The aims of this study were to validate the feasibility and safety of SPACE for esophageal endoscopic submucosal dissection (ESD).
This was a clinical phase I trial, involving 10 patients who underwent esophageal ESD. The primary end point was the rate of adverse events within 30 days (grade 0 to 4). Secondary end points were changes in partial pressure of carbon dioxide (PaCO2) and vital signs during ESD, completion rate of ESD, and degree of abdominal distension by patient assessment and radiographic grading.
All adverse events were Grade 2 or less. Mild PaCO2 elevation after ESD was noted; however, no associated symptoms were reported. The procedure was completed under SPACE alone in 8 of 10 patients. Minimal post-procedural bowel distension was observed.
In this small pilot study, SPACE was feasible and appeared to be safe. Further study with larger case numbers is required to demonstrate efficacy and safety.
UMIN000005434.
稳定压力自动控制内镜检查（SPACE）是一种新型的充气系统，可在长时间手术过程中提供恒定的二氧化碳（CO₂）充气压力。该系统由外套管、手术充气器和新开发的防漏阀组成。本研究的目的是验证SPACE用于食管内镜黏膜下剥离术（ESD）的可行性和安全性。
这是一项I期临床试验，纳入了10例行食管ESD的患者。主要终点是30天内不良事件的发生率（0至4级）。次要终点包括ESD期间二氧化碳分压（PaCO₂）和生命体征的变化、ESD的完成率以及通过患者评估和影像学分级得出的腹胀程度。
所有不良事件均为2级或以下。ESD后观察到轻度的PaCO₂升高；然而，未报告相关症状。10例患者中有8例仅在SPACE系统下完成了手术。术后观察到最小程度的肠胀气。
在这项小型初步研究中，SPACE是可行的且似乎是安全的。需要更大样本量的进一步研究来证明其有效性和安全性。
UMIN000005434。
