Evaluation of Antral Biopsies Obtained in Normal Esophagogastroduodenoscopy

Not Applicable

Completed

• Conditions: Gastritis Chronic; Gastritis H Pylori; Intestinal Metaplasia
• Interventions: Procedure: Esophagogastroduodenoscopy; Procedure: Endoscopic biopsy sampling

• Registration Number: NCT06269380
• Lead Sponsor: Sisli Hamidiye Etfal Training and Research Hospital

Brief Summary

Esophagogastroduodenoscopy (EGD) is commonly performed in patients presenting with abdominal pain and dyspeptic symptoms, serving as a valuable diagnostic and therapeutic tool. While various methods are available for biopsy sampling when mucosal pathology is observed during EGD, the practice of obtaining biopsies from endoscopically normal mucosa remains controversial. Although there is literature suggesting that routine biopsies from the antrum and duodenum for surveillance purposes increase costs, pathological findings can sometimes be detected in areas that appear normal on mucosal examination, leading to potential changes in treatment approach if biopsies are obtained.

In this study, a retrospective evaluation of the prevalence of various pathologies detected in biopsies obtained from endoscopically normal mucosa in patients who underwent EGD was reported as normal.

Detailed Description

Esophagogastroduodenoscopy (EGD) is a commonly used diagnostic tool in upper gastrointestinal system diseases. Its widespread use is facilitated by its minimally invasive nature, the possibility of therapeutic procedures, low complication rates, and broad applicability. Although there are numerous guidelines regarding approaches to endoscopic pathologies and diseases detected during esophagogastroduodenoscopy, the necessity of biopsy sampling from mucosal areas that are endoscopically normal remains controversial.

In this study, patients aged between 18 and 95 who underwent EGD at the Sisli Hamidiye Etfal Training and Research Hospital Surgical Endoscopy Unit between 2021 and 2023, with no pathology detected during the endoscopic examination and who underwent biopsy sampling, will be evaluated. History of upper gastrointestinal surgery, detection of the endoscopic pathology, and not having biopsy sampling will be considered as exclusion criteria. The rate of detection of histopathological findings in the obtained biopsies, severity and activity of gastritis, rate and density of Helicobacter pylori detection, and rate and extent of intestinal metaplasia will be evaluated.

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-12
• Study First Submitted QC: 2024-02-12
• Study Start: 2024-02-13
• Primary Completion: 2024-02-20
• Study Completion: 2024-02-21
• Study First Posted: 2024-02-21
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 671

Inclusion Criteria

• Patients aged between 18-95
• Endoscopically normal esophagogastroduodenoscopy
• Sampling biopsies must be obtained

Exclusion Criteria

• History of upper gastrointestinal surgery
• Abnormal endoscopic findings such as gastritis, ulcer, hiatal hernia, pyloric deformity, alkaline reflux
• Not having biopsy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Normal esophagogastroduodenoscopy	Esophagogastroduodenoscopy	Patients with normal esophagogastroduodenoscopic findings and biopsy samples were obtained.
Normal esophagogastroduodenoscopy	Endoscopic biopsy sampling	Patients with normal esophagogastroduodenoscopic findings and biopsy samples were obtained.

Primary Outcome Measures

Name	Time	Method
Rate of abnormal histopathologic findings	2 week after esophagogastroduodenoscopy	Rate of abnormal histopathologic findings in patients with normal esophagogastroduodenoscopy and sampling biopsies obtained

Secondary Outcome Measures

Name	Time	Method
Rate of intestinal metaplasia	2 week after esophagogastroduodenoscopy	Rate of intestinal metaplasia in patients with normal esophagogastroduodenoscopy and sampling biopsies obtained
Rates of gastritis severity and activity	2 week after esophagogastroduodenoscopy	Rate of gastritis severity and activity in patients with normal esophagogastroduodenoscopy and sampling biopsies obtained
Rate of Helicobacter Pylori positivity	2 week after esophagogastroduodenoscopy	Rate of Helicobacter Pylori positivity in patients with normal esophagogastroduodenoscopy and sampling biopsies obtained

Trial Locations

Locations (1)

Sisli Hamidiye Etfal Research and Training Hospital; 🇹🇷 Istanbul, Turkey