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Published on: February 14, 2022
Translation from manual to automatic endoscopic insufflation enhanced by a pressure limiter
Yuki Ushimaru1,2, Tsuyoshi Takahashi2, Kotaro Yamashita2
1Department of Next Generation Endoscopic Intervention (Project ENGINE), Center of Medical Innovation and Translational Research, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suite 0912, Osaka, 565-0871, Japan.
Background:
Optimal visualization and safety have always been essential in performing any type of endoscopic surgery. However, the safety of automatic gastrointestinal (GI) insufflation has yet to be thoroughly studied, especially when combined with manual insufflation. The current study aimed to verify whether the pressure limiter could lower GI endoluminal pressure during endoscopic procedures and affect the behavioral patterns of endoscopists.
Methods:
A preclinical blinded trial was conducted on endoscopists who had no knowledge regarding the presence of the pressure limiter that prevents a GI endoluminal pressure above 25 mmHg. Endoscopists in group A performed esophageal endoscopic submucosal dissection (ESD) with our insufflation device equipped with the pressure limiter, whereas those in group B performed the same procedure without the pressure limiter. During all procedures, endoluminal pressure was continuously monitored. The primary endpoint of the current study was to measure the endoluminal pressure with or without the pressure limiter during esophageal ESD, while the secondary endpoint was to evaluate the effect of the pressure limiter on intraesophageal pressure and perioperative outcomes during esophageal ESD. A questionnaire survey was conducted after each session.
Results:
A total of 79 endoscopists were included in this randomized control study. Group A had significantly lower endoluminal pressure than group B (10.6 ± 4.61 vs. 16.25 ± 7.51 mmHg, respectively; p < 0.05). Although two pigs in group B died from tension pneumothorax, none in group A died. Evaluation of lumen expansion, ease of aspiration, and visual field reproducibility were poorer in group A than in group B, although all fell within the acceptable range. Subjective evaluation of usability was divided into two categories, Excellent/Good and Poor/Bad, with no significant differences in any of the items.
Conclusions:
This preclinical study showed that endoscopic treatment with an automatic insufflation system could be performed at lower endoluminal pressure with a pressure limiter, which had no adverse effects on the endoscopist's feels on endoscopic procedures with the device.
