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

Area of Science:

• Gastroenterology
• Endoscopy
• Surgical Innovation

Background:

• Steady Pressure Automatically Controlled Endoscopy (SPACE) is a novel insufflation system designed for sustained carbon dioxide (CO2) pressure during lengthy endoscopic procedures.
• The SPACE system integrates an overtube, a surgical insufflator, and a specialized leak-proof valve.

Purpose of the Study:

• To evaluate the feasibility and safety of the SPACE system for esophageal endoscopic submucosal dissection (ESD).

Main Methods:

• A clinical phase I trial was conducted with 10 patients undergoing esophageal ESD.
• Primary endpoint: rate of adverse events (Grade 0-4) within 30 days.
• Secondary endpoints: changes in partial pressure of carbon dioxide (PaCO2), vital signs, ESD completion, and abdominal distension.

Main Results:

• No adverse events exceeding Grade 2 were reported.
• A mild, asymptomatic elevation in PaCO2 was observed post-ESD.
• Esophageal ESD was successfully completed using SPACE alone in 80% of patients, with minimal post-procedural abdominal distension.

Conclusions:

• The SPACE system appears feasible and safe for esophageal ESD in this preliminary study.
• Larger-scale studies are necessary to confirm the efficacy and safety profile of SPACE.