Gastric endoscopic submucosal dissection under steady pressure automatically controlled endoscopy (SPACE); a multicenter randomized preclinical trial.

Abstract

Steady pressure automatically controlled endoscopy (SPACE) is a new modality that eliminates on-demand insufflation but enables automatic insufflation in the gastrointestinal tract. Though its use in porcine esophageal ESD was reported to be promising, its applicability and potential effectiveness to gastric procedures have not been evaluated. The aims were (1) to evaluate feasibility and safety of SPACE in the stomach, and (2) to assess its potential advantages over conventional endoscopy in preventing "blind insufflation"-related complications. A multicenter randomized preclinical animal study. Laboratories at three universities. Experiment 1: Gastric ESD was attempted in the swine (n=17), under either SPACE or manual insufflation. Experiment 2: Gastroscopy was performed for 10min in the perforated stomach (n=10) under either SPACE or manual insufflation. Experiment 1: ESD time, energy device activation time, number of forceps exchanges, specimen size, en block resection rate, vital signs and any intraoperative adverse events. Experiment 2: Intra-gastric and intra-abdominal pressures, vital signs, and any adverse events. Experiment 1: Gastric ESD was completed in all animals. ESD time tended to be shorter in SPACE than in the control, though the difference was not significant (p=0.18). Experiment 2: Although both intra-gastric and intra-abdominal pressures remained within preset values in SPACE, they showed excessive elevation in control. An animal study with small sample size. SPACE is feasible and safe for complicated and lengthy procedures such as gastric ESD, and is potentially effective in preventing serious consequences related to excessive blind insufflation.