Evaluation of Antral Biopsies Obtained in Normal Esophagogastroduodenoscopy

Intestinal Metaplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06269380
• Other study ID #: 30.01.2024-4274
• Status: Completed
• Phase: N/A
• Start date: February 13, 2024
• Est. completion date: February 21, 2024

Study information

• Verified date: February 2024
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 671
• Est. completion date: February 21, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastritis
• Gastritis Chronic
• Gastritis H Pylori
• Intestinal Metaplasia
• Metaplasia

Intervention

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

Locations

Country	Name	City	State
Turkey	Sisli Hamidiye Etfal Research and Training Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of abnormal histopathologic findings	Rate of abnormal histopathologic findings in patients with normal esophagogastroduodenoscopy and sampling biopsies obtained	2 week after esophagogastroduodenoscopy
Secondary	Rate of intestinal metaplasia	Rate of intestinal metaplasia in patients with normal esophagogastroduodenoscopy and sampling biopsies obtained	2 week after esophagogastroduodenoscopy
Secondary	Rates of gastritis severity and activity	Rate of gastritis severity and activity in patients with normal esophagogastroduodenoscopy and sampling biopsies obtained	2 week after esophagogastroduodenoscopy
Secondary	Rate of Helicobacter Pylori positivity	Rate of Helicobacter Pylori positivity in patients with normal esophagogastroduodenoscopy and sampling biopsies obtained	2 week after esophagogastroduodenoscopy