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Completed

NCT Number: NCT06269380

Evaluation of Antral Biopsies Obtained in Normal Esophagogastroduodenoscopy

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.

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Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sisli Hamidiye Etfal Research and Training Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esophagogastroduodenoscopy

Procedure

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

Endoscopic biopsy sampling

Procedure

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

Primary outcomes

  1. Rate of abnormal histopathologic findings

    Time frame: 2 week after esophagogastroduodenoscopy

    Rate of abnormal histopathologic findings in patients with normal esophagogastroduodenoscopy and sampling biopsies obtained

Secondary outcomes

  1. Rate of intestinal metaplasia

    Time frame: 2 week after esophagogastroduodenoscopy

    Rate of intestinal metaplasia in patients with normal esophagogastroduodenoscopy and sampling biopsies obtained

  2. Rates of gastritis severity and activity

    Time frame: 2 week after esophagogastroduodenoscopy

    Rate of gastritis severity and activity in patients with normal esophagogastroduodenoscopy and sampling biopsies obtained

  3. Rate of Helicobacter Pylori positivity

    Time frame: 2 week after esophagogastroduodenoscopy

    Rate of Helicobacter Pylori positivity in patients with normal esophagogastroduodenoscopy and sampling biopsies obtained

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 21, 2024
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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