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

Motohiko Kato, Kiyokazu Nakajima, Takuya Yamada, Masashi Hirota, Yasuaki Miyazaki, Makoto Yamasaki, Tsutomu Nishida, Masaki Mori, Yuichiro Doki, Masahiko Tsujii, Tetsuo Takehara

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Abstract

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 PaCO2elevation 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.

Original languageEnglish
Pages (from-to)680-684
Number of pages5
JournalEndoscopy
Volume46
Issue number8
DOIs
Publication statusPublished - 2014 Aug

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ASJC Scopus subject areas

  • Gastroenterology

Cite this

Kato, M., Nakajima, K., Yamada, T., Hirota, M., Miyazaki, Y., Yamasaki, M., Nishida, T., Mori, M., Doki, Y., Tsujii, M., & Takehara, T. (2014). Esophageal submucosal dissection under steady pressure automatically controlled endoscopy (SPACE): A clinical feasibility study. Endoscopy, 46(8), 680-684. https://doi.org/10.1055/s-0034-1365465