Korean J Helicobacter Up Gastrointest Res.  2019 Dec;19(4):257-265. 10.7704/kjhugr.2019.0009.

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

• Ha DW
• Kim GH
• Lee BE
• Lee MW
• Baek DH
• Kim DU
• Song GA

• KMID: 2469317
• DOI: http://doi.org/10.7704/kjhugr.2019.0009

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.

Keyword

Endoscopic submucosal dissection; Patient positioning; Stomach neoplasm

MeSH Terms

Busan
Humans
Meperidine
Neoplasms, Glandular and Epithelial*
Patient Positioning
Propofol
Prospective Studies*
Stomach Neoplasms
Meperidine
Propofol