Evaluation of Antral Biopsies Obtained in Normal Esophagogastroduodenoscopy

S

Sisli Hamidiye Etfal Training and Research Hospital

Status

Completed

Conditions

Gastritis Chronic
Intestinal Metaplasia
Gastritis H Pylori

Treatments

Procedure: Esophagogastroduodenoscopy
Procedure: Endoscopic biopsy sampling

Study type

Interventional

Funder types

Other

Identifiers

NCT06269380
30.01.2024-4274

Details and patient eligibility

About

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.

Full 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.

Enrollment

671 patients

Sex

All

Ages

18 to 95 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

671 participants in 1 patient group

Normal esophagogastroduodenoscopy
Experimental group
Description:
Patients with normal esophagogastroduodenoscopic findings and biopsy samples were obtained.
Treatment:
Procedure: Endoscopic biopsy sampling
Procedure: Esophagogastroduodenoscopy

Trial contacts and locations

1

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Central trial contact

Burak Dincer, M.D.

Data sourced from clinicaltrials.gov

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