Abstract
ABSTRACT
Background and Aims
The Endoscopic Pressure Study Integrated System (EPSIS) is a novel endoscopic tool to assess lower esophageal sphincter (LES) function by monitoring intragastric pressure (IGP) through insufflation. While previous studies have confirmed its diagnostic utility for LES dysfunction‐related disorders such as gastroesophageal reflux disease and achalasia, there have been no reports evaluating its safety. Thus, this study aimed to assess its complication rates and detailed characteristics.
Methods
We retrospectively reviewed 1205 consecutive EPSIS cases performed between December 2015 and September 2024 at our institution. Cases with adverse events (AEs) were identified, and clinical characteristics, waveform patterns, IGP parameters, and need for additional treatment were analyzed.
Results
AEs occurred in 35 cases (2.9%), including 32 cases (2.7%) of micro‐mucosal bleedings (MMBs) and three cases (0.25%) of superficial mucosal tears (SMTs). All cases were minor (Clavien‐Dindo grade I), without the need for any additional intervention. All 35 cases exhibited an uphill waveform. SMTs were associated with pressure spikes due to vomiting or belching. No serious AEs, including perforations or active bleeding, were observed.
Conclusions
EPSIS is a safe and minimally invasive procedure, with low complication rates comparable to routine upper endoscopy. To maintain its safety, EPSIS should be performed under sedation with CO₂ insufflation. In addition, insufflation during EPSIS should be controlled so that the IGP is maintained less than 25 mmHg. However, this threshold may vary depending on the patient's underlying conditions or clinical background; therefore, further research is warranted.
Clinical Trial Registration
N/A.