Esophageal submucosal dissection under steady pressure automatically controlled endoscopy (SPACE): a clinical feasibility study
submitted 25 September 2013
accepted after revision 19 February 2014
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
- 1 Nakajima K, Nishida T, Milsom JW et al. Current limitations in endoscopic CO2 insufflation for NOTES: flow and pressure study. Gastrointest Endosc 2010; 72: 1036-1042
- 2 McGee MF, Rosen MJ, Marks J et al. A reliable method for monitoring intraabdominal pressure during natural orifice translumenal endoscopic surgery. Surg Endosc 2007; 21: 672-676
- 3 von Delius S, Huber W, Feussner H et al. Effect of pneumoperitoneum on hemodynamics and inspiratory pressures during natural orifice transluminal endoscopic surgery (NOTES): an experimental, controlled study in an acute porcine model. Endoscopy 2007; 39: 854-861
- 4 Omori T, Nakajima K, Ohashi S et al. Laparoscopic intragastric surgery under carbon dioxide pneumostomach. J Laparoendosc Adv Surg Tech Part A 2008; 18: 47-51
- 5 Kato M, Nishida T, Tsutsui S et al. Endoscopic submucosal dissection as a treatment for gastric noninvasive neoplasia: a multicenter study by Osaka University ESD Study Group. J Gastroenterol 2011; 46: 325-331
- 6 Kato M, Nishida T, Yamamoto K et al. Scheduled endoscopic surveillance controls secondary cancer after curative endoscopic resection for early gastric cancer: a multicentre retrospective cohort study by Osaka University ESD study group. Gut 2013; 62: 1425-1432
- 7 Nakajima K, Moon JH, Tsutsui S et al. Esophageal submucosal dissection under steady pressure automatically controlled endoscopy (SPACE): a randomized preclinical trial. Endoscopy 2012; 44: 1139-1148
- 8 Souma Y, Nakajima K, Takahashi T et al. The role of intraoperative carbon dioxide insufflating upper gastrointestinal endoscopy during laparoscopic surgery. Surg Endosc 2009; 23: 2279-2285