Abstract
This randomized trial aimed to compare the safety and efficacy of the GAGLESS mouthpiece for esophagogastroduodenoscopy (EGD) with that of the conventional mouthpiece. In all, 90 participants were divided into the GAGLESS mouthpiece and conventional mouthpiece groups. The primary endpoint was the severity of pain using the visual analog scale (VAS), and secondary endpoints were examination time, past history of endoscopy, success of the procedure, systolic (SBP) and diastolic (DBP) blood pressure, oxygen saturation, pulse rate before and after EGD, and adverse events. Endoscopy was completed in all cases, and no complications were observed. VAS, when passing the scope through the pharynx, was 2.5 ± 2.4 and 2.0 ± 1.9 cm (p = 0.24) in the conventional and GAGLESS groups, respectively, and that, throughout the examination, was 2.5 ± 2.4 and 1.7 ± 1.5 cm (p = 0.06), respectively. The difference in blood pressure between the GAGLESS and conventional groups was not significant for SBP (p = 0.08) and significant for DBP (p = 0.03). The post-EGD difference in DBP was significantly lower in the GAGLESS group than in the conventional group. The results indicate that GAGLESS mouthpieces had a lower VAS during endoscopy than the conventional mouthpieces, and the changes in blood pressure were smaller with the GAGLESS mouthpiece.
Highlights
Both groups were well balanced in terms of age, history of previous endoscopic examination, systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse rate (PR), and SpO2
In the present report, when the scope passed through the pharynx, the overall visual analog scale (VAS) was lower with the GAGLESS mouthpiece than with the conventional mouthpieces
The difference in DBP before and after the endoscopic examination was significantly small with the GAGLESS mouthpiece, suggesting that it might be less likely to cause a change in the hemodynamics compared to that with the conventional mouthpieces
Summary
Gastric cancer is the third leading cause of cancer-related mortality worldwide [1]. The prognosis can be improved by early detection [2], and, if detected early, it can be cured by endoscopic treatment [3]. It has been reported that, within the Korean National Cancer Screening Program, patients who underwent upper endoscopy were less likely to die from gastric cancer [4]. In Japan, Hamashima et al reported that endoscopic screening could reduce the mortality from gastric cancer by 67% when compared to that with gastric radiographic screening [5]. The challenge with endoscopic screening is the pain associated with endoscopy. Endoscopy is performed under sedation [6,7].
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