Sa1057 THREE-DIMENSIONAL UPPER GASTROINTESTINAL ENDOSCOPY: A CLINICAL STUDY OF SAFETY AND AN EX VIVO STUDY OF UTILITY IN ENDOSCOPIC SUBMUCOSAL DISSECTION

Abstract

The utility of three-dimensional (3D) endoscopy in the field of therapeutic endoscopy was investigated ex vivo using a newly developed 3D endoscope. Also, we conducted a clinical study to investigate the safety of 3D endoscopy as an upper gastrointestinal (GI) screening tool in actual clinical practice using the 3D endoscope, which had recently been approved as a medical device. To investigate the utility of this 3D endoscope in therapeutic endoscopy, an excised pig stomach with a 10-mm hypothetical lesion was attached to an endoscopic training simulator. The outcomes of endoscopic submucosal dissection (ESD) performed under two-dimensional (2D) and 3D conditions were compared based on the rate of en bloc resection, incidence of perforation, time required for circumferential incision and resection, and severity of eyestrain based on the symptoms of eyestrain, eye pain, blurred vision, heavy-headedness, and headache. Severity of eyestrain was evaluated before and after ESD using a visual analog scale (VAS; 0–100 mm). Eight endoscopists each performed ESD on 4 hypothetical lesions (2 lesions each for 2D and 3D endoscopy). A clinical study was conducted to investigate the safety of 3D endoscopy in 60 patients (36 men, 24 women; mean age 59.3 years) who had given written informed consent to participate in the study. We evaluated the severity of eyestrain in endoscopists before and after each endoscopic procedure, by using the VAS. All 32 lesions were resected en bloc. Perforation was observed in one 2D case. Circumferential incision time was significantly shorter in the 3D group than in the 2D group (102.8 ± 42.1 vs. 135.8 ± 65.7, respectively; p < 0.05), as was resection time (366.3 ± 187.6 s vs. 517.8 ± 282.3 s, respectively; p < 0.05). Intergroup comparisons revealed that the severity of eyestrain-related symptoms, except for blurred vision, was significantly higher in the 3D group than in the 2D group. In the clinical study, none of the 60 patients developed adverse events such as bleeding and perforation, demonstrating the safety of 3D endoscopy. Severity of eyestrain in the endoscopists was significantly higher for all items, except for headache, after endoscopic procedure. Resection time was significantly shorter in 3D ESD than in 2D ESD. Also, 3D ESD was performed safely, with no incidence of perforation. These findings suggest that 3D endoscopy enables rapid and stable ESD because of easy recognition of structures and acquisition of depth information. Furthermore, in the clinical study, 3D endoscopy was performed safely, with no occurrence of severe adverse events.