Frequency and Types of Pathological Upper Gastrointestinal Endoscopy Findings in Clinically Healthy Individuals

Abstract

Background and objective Beyond its application for diagnostics in patients, esophagogastroduodenoscopy (EGD) is used to assess gastrointestinal drug effects in clinical trials, where the interpretation of any pathological findings depends on the respective background variability. The objective of this analysis was to characterize the occurrence of pathological findings in the upper gastrointestinal tract in symptom-free healthy individuals. Methods A baseline EGD was performed in clinically healthy individuals in three clinical trials aimed to assess gastrointestinal tolerability of drugs. Pathological findings were described by type (redness, erosion, ulcer or other), number, size and location, and by clinical relevance as assessed by the endoscopist. Characteristics of volunteers were tested as potential covariates. Results A total of 294 EGDs were assessed. Characteristics of individuals were as follows: 257 (87.4%) males, age (mean ± SD) 32.0 ± 8.1 years, body weight 76.0 ± 10.6 kg, body mass index (BMI) 24.0 ± 2.5 kg/m 2 , 200 consumed alcohol, 250 (of 290 where this information was available) consumed caffeine and 39 (of 152) were smokers, 30 (of 151) tested positive for H. pylori. Any pathological finding was present in 79.6%. Clinically relevant findings occurred in 44.2%, mainly erosions (39.1%). Nine stomach ulcers were observed. Only age and BMI had a statistically significant relationship to overall pathological findings [age 3.4 years higher (p = 0.027), and BMI 1.6 kg/m 2 higher (p < 0.001); for clinically relevant vs no findings]. Conclusion Upper gastrointestinal tract mucosal lesions, including those assessed as clinically relevant, are frequent in clinically healthy individuals, impeding the assessment of causality for both disease and drug effects on gastrointestinal health. Abbreviations BMI Body mass index CR Clinical relevant ECG Electrocardiogram EGD Esophagogastroduodenoscopy FIH First-inhuman GI Gastrointestinal NCR Not clinical relevant NSAID Nonsteroidal anti-inflammatory drug Key Point Pathological findings in esophagogastroduodenoscopy are frequent in healthy individuals without clinical symptoms and need to be considered to assess adverse drug effects in early clinical trials.

Cross Section Study of Endoscopic Findings in Patients Underwent Upper Endoscopy in Fayoum University Hospital

“…12 On the other hand, Scheidl et al, 2020 which included younger patients the mean age was 32 years. 13 Regarding to gender, our study showed that there is slight predominance of female gender patients in percent of 50.1%, versus 49.9% were males.…”