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Evaluation of Antral Biopsies Obtained in Normal Esophagogastroduodenoscopy

Evaluation of Antral Biopsies Obtained in Normal Esophagogastroduodenoscopy: A Retrospective Cohort Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06269380
Enrollment
671
Registered
2024-02-21
Start date
2024-02-13
Completion date
2024-02-21
Last updated
2024-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastritis Chronic, Gastritis H Pylori, Intestinal Metaplasia

Keywords

Esophagogastroduodenoscopy, Routine biopsy, Intestinal metaplasia

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.

Interventions

PROCEDUREEsophagogastroduodenoscopy

During the procedure, endoscopic examination of the upper gastrointestinal tract was made. Biopsy sampling can be made during procedure if endoscopist deemed necessary.

PROCEDUREEndoscopic biopsy sampling

The obtaining of biopsy samples for control purposes despite the absence of endoscopic pathology during esophagogastroduodenoscopy.

Sponsors

Sisli Hamidiye Etfal Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

The biopsies obtained from patients who underwent esophagogastroduodenoscopy and were found to have normal endoscopic findings will be evaluated. The histopathological findings and their frequencies in these biopsies will be examined to assess the necessity of routine biopsy during esophagogastroduodenoscopy.

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of abnormal histopathologic findings2 week after esophagogastroduodenoscopyRate of abnormal histopathologic findings in patients with normal esophagogastroduodenoscopy and sampling biopsies obtained

Secondary

MeasureTime frameDescription
Rate of intestinal metaplasia2 week after esophagogastroduodenoscopyRate of intestinal metaplasia in patients with normal esophagogastroduodenoscopy and sampling biopsies obtained
Rates of gastritis severity and activity2 week after esophagogastroduodenoscopyRate of gastritis severity and activity in patients with normal esophagogastroduodenoscopy and sampling biopsies obtained
Rate of Helicobacter Pylori positivity2 week after esophagogastroduodenoscopyRate of Helicobacter Pylori positivity in patients with normal esophagogastroduodenoscopy and sampling biopsies obtained

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026