1. Esophageal submucosal dissection under steady pressure automatically controlled endoscopy (SPACE): a clinical feasibility study
- Author
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Motohiko Kato, Masashi Hirota, Kiyokazu Nakajima, Makoto Yamasaki, Yuichiro Doki, Masahiko Tsujii, Masaki Mori, Tetsuo Takehara, Takuya Yamada, Tsutomu Nishida, and Yasuaki Miyazaki
- Subjects
Male ,Insufflation ,Chest Pain ,medicine.medical_specialty ,Esophageal Neoplasms ,Partial Pressure ,Vital signs ,Pilot Projects ,medicine ,Clinical endpoint ,Humans ,Adverse effect ,Aged ,Mucous Membrane ,medicine.diagnostic_test ,business.industry ,Dissection ,Gastroenterology ,Carbon Dioxide ,Middle Aged ,Abdominal distension ,Endoscopy ,Surgery ,Clinical trial ,Carcinoma, Squamous Cell ,Feasibility Studies ,Female ,Esophagoscopy ,medicine.symptom ,Deglutition Disorders ,business ,Carcinoma in Situ - 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 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
- Published
- 2014