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


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.


BACKGROUND
UMIN000005434.
Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan.
Motohiko
M
Kato
Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
Kiyokazu
K
Nakajima
Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan.
Takuya
T
Yamada
Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
Masashi
M
Hirota
Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
Yasuaki
Y
Miyazaki
Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
Makoto
M
Yamasaki
Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan.
Tsutomu
T
Nishida
Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
Masaki
M
Mori
Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
Yuichiro
Y
Doki
Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan.
Masahiko
M
Tsujii
Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan.
Tetsuo
T
Takehara
D000368:Aged; D002245:Carbon Dioxide / Q000097:blood; D002278:Carcinoma in Situ / Q000601:surgery*; D002294:Carcinoma, Squamous Cell / Q000601:surgery*; D002637:Chest Pain / Q000209:etiology; D003680:Deglutition Disorders / Q000209:etiology; D004210:Dissection; D004938:Esophageal Neoplasms / Q000601:surgery*; D004945:Esophagoscopy / Q000009:adverse effects* / Q000295:instrumentation*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007327:Insufflation / Q000009:adverse effects* / Q000295:instrumentation*; D008297:Male; D008875:Middle Aged; D009092:Mucous Membrane / Q000601:surgery; D010313:Partial Pressure; D010865:Pilot Projects
D002245:Carbon Dioxide