Clinical trial NCT06269380: Evaluation of Antral Biopsies Obtained in Normal Esophagogastroduodenoscopy
Official title: Evaluation of Antral Biopsies Obtained in Normal Esophagogastroduodenoscopy: A Retrospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastritis H Pylori
Gastritis Chronic
Intestinal Metaplasia
Keywords: Esophagogastroduodenoscopy
Routine biopsy
Intestinal metaplasia
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 671
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of abnormal histopathologic findings
timeFrame: 2 week after esophagogastroduodenoscopy
Secondary outcomes:
measure: Rate of intestinal metaplasia
timeFrame: 2 week after esophagogastroduodenoscopy
measure: Rates of gastritis severity and activity
timeFrame: 2 week after esophagogastroduodenoscopy
measure: Rate of Helicobacter Pylori positivity
timeFrame: 2 week after esophagogastroduodenoscopy
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sisli Hamidiye Etfal Research and Training Hospital
Study officials:
affiliation: Sisli Hamidiye Etfal Training and Research Hospital
name: Burak Dincer, M.D.
role: PRINCIPAL_INVESTIGATOR
References: