Endoscopy 2014; 46(08): 680-684
DOI: 10.1055/s-0034-1365465
Innovations and brief communications
© Georg Thieme Verlag KG Stuttgart · New York

Esophageal submucosal dissection under steady pressure automatically controlled endoscopy (SPACE): a clinical feasibility study

Motohiko Kato
1  Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan
,
Kiyokazu Nakajima
2  Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan
3  Division of Collaborative Research for Next-Generation Endoscopic Intervention (Project ENGINE), The Center for Advanced Medical Engineering and Informatics, Osaka University, Osaka, Japan
,
Takuya Yamada
1  Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan
,
Masashi Hirota
2  Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan
3  Division of Collaborative Research for Next-Generation Endoscopic Intervention (Project ENGINE), The Center for Advanced Medical Engineering and Informatics, Osaka University, Osaka, Japan
,
Yasuaki Miyazaki
2  Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan
,
Makoto Yamasaki
2  Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan
,
Tsutomu Nishida
1  Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan
,
Masaki Mori
2  Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan
,
Yuichiro Doki
2  Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan
,
Masahiko Tsujii
1  Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan
,
Tetsuo Takehara
1  Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan
› Author Affiliations
Further Information

Publication History

submitted 25 September 2013

accepted after revision 19 February 2014

Publication Date:
25 April 2014 (eFirst)

Background and study aims: 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).

Patients and methods: 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.

Results: 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.

Conclusions: 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.

Clinical trial registration: UMIN000005434