Efficacy and Safety of a Patient-positioning Device (EZ-FIX® Cushion) during Endoscopic Submucosal Dissection of Gastric Epithelial Neoplasm: A Prospective Randomized Trial

Abstract

Background/Aims: Cooperation of patients plays an essential role during gastric endoscopic submucosal dissection (ESD) for successful outcomes. We aimed to assess the efficacy and safety of a patient-positioning device (EZ-FIX ®) during ESD for gastric epithelial neoplasm. Materials and Methods: In this prospective study, 86 consecutive patients with gastric epithelial neoplasm scheduled for ESD at the Pusan National University Hospital were included and randomly assigned to the EZ-FIX ® (n=44) or non-EZ-FIX ® (n=42) groups. The primary outcomes measured were endoscopist satisfaction profiles and contribution level of EZ-FIX ® to the procedure. Results: No significant differences were observed between the two groups regarding patients' clinicopathologic characteristics, though the mean procedure time was longer in the EZ-FIX ® group (P=0.044). In the EZ-FIX ® group, 16 patients (36.4%) were categorized as a contribution group. Subgroup analysis between the contribution and non-contribution groups revealed that the contribution group had a larger lesion size (P=0.043) and a longer procedure time (P=0.037) and showed a higher patient's movement score (P<0.001) with a higher dosage of propofol (P=0.004) and pethidine (P=0.001) required. Endoscopist satisfaction scores on sedation (P<0.001) and overall procedure (P=0.010) were lower in the contribution group. Conclusions: Thus, EZ-FIX ® might be helpful especially for patients who are expected to exhibit uncooperative sedation or those with a large lesion size, which would necessitate a longer procedure time.