Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Gastrointestinal Myoelectrical Activity (GIMA) Biomarker for Noninvasive Diagnosis of Endometriosis

Version 1 : Received: 7 April 2024 / Approved: 8 April 2024 / Online: 8 April 2024 (10:02:42 CEST)

How to cite: Noar, M.; Mathias, J.; Kolatkar, A. Gastrointestinal Myoelectrical Activity (GIMA) Biomarker for Noninvasive Diagnosis of Endometriosis. Preprints 2024, 2024040527. https://doi.org/10.20944/preprints202404.0527.v1 Noar, M.; Mathias, J.; Kolatkar, A. Gastrointestinal Myoelectrical Activity (GIMA) Biomarker for Noninvasive Diagnosis of Endometriosis. Preprints 2024, 2024040527. https://doi.org/10.20944/preprints202404.0527.v1

Abstract

Background/Objectives: Endometriosis represents substantial direct and indirect healthcare costs impacted by absent accurate, non-invasive uniformly diagnostic tools. We endeavored to demonstrate gastrointestinal myoelectrical activity (GIMA) biomarkers unique to endometriosis allow noninvasive, uniformly accurate diagnosis or exclusion of endometriosis. Methods: Prospective open-label comparative study of 154 patients, age >18, with or without diagnosed endometriosis. Population included 62 non-endometriosis controls (Cohort 1), 43 subjects with surgically histologically-confirmed endometriosis (Cohort 2), and 49 subjects with abdominal pain and negative imaging (Cohort 3). Electroviscerography (EVG) recorded GIMA biomarkers from three abdominal electrodes before and 30-minutes post water-load protocol. Cohort 2 had postoperative EVG and Cohort 3 had preoperative EVG. Calculated specificity, sensitivity, NPV, PPV and predictive probability or C-Statistic used univariate, multivariate, linear and logistical regression analyses of the area under the curve (AUC) at all frequency and time points, including age and pain covariants. Results: Non-endometriosis cohort differed significantly from endometriosis cohorts (p<0.001) for median (IQR), and AUC percent frequency distribution of power at baseline, 10-minute, 20-minute, and 30-minute post water-load at all frequency ranges 15-20cpm, 30-40cpm and 40-50cpm. Endometriosis cohorts were statistically similar (p>0.05). GIMA biomarker threshold scoring demonstrated 95%/91% sensitivity and PPV, 96%/95% specificity and NPV and C-statistic of >99%/98% respectively for age subsets. GIMA biomarkers in Cohort 3 predicted 47/49 subjects positive and 2/49 negative for endometriosis, confirmed surgically. Hormonal therapy, surgical stage, nor pain score affected diagnostic accuracy. Conclusions: Non-invasive electroviscerography with GIMA biomarker detection distinguished participants with and without endometriosis based upon endometriosis specific GIMA biomarkers threshold scoring.

Keywords

biomarker; electroviscerography; endometriosis; gastrointestinal myoelectrical activity; GIMA; electroviscerogram; water load satiety test; GIMA biomarker threshold score; predictive modeling 

Subject

Medicine and Pharmacology, Obstetrics and Gynaecology

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