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

Area of Science:

• Gastroenterology
• Endoscopic Technology
• Surgical Innovation

Background:

• A novel overtube system for steady pressure automatically controlled endoscopy (SPACE) has been developed.
• SPACE aims to enhance gastrointestinal endoscopy procedures.

Purpose of the Study:

• To validate the feasibility and safety of SPACE in esophageal applications.
• To compare SPACE with conventional endoscopy for endoscopic submucosal dissection (ESD).

Main Methods:

• A multicenter preclinical trial involving 20 porcine models.
• Experiment 1: Assessed SPACE feasibility and safety in the esophagus, optimizing insufflation pressure.
• Experiment 2: Randomized trial comparing SPACE and conventional endoscopy for esophageal ESD.

Main Results:

• SPACE was safely performed without adverse intraluminal pressure changes.
• SPACE provided superior visualization stability, reproducibility, and speed compared to conventional endoscopy.
• Endoscopic submucosal dissection (ESD) time was significantly reduced with SPACE (1326 vs. 1616 seconds; P = 0.009).
• SPACE was associated with improved exposure and tissue tension, as rated by participants.

Conclusions:

• SPACE is a feasible and safe endoscopic system for complex procedures like ESD.
• SPACE enhances and standardizes endoscopic visualization and tissue tension.
• Further clinical studies are warranted to confirm SPACE's safety and efficacy.