Evaluation of Antral Biopsies Obtained in Normal Esophagogastroduodenoscopy

NCT ID: NCT06269380

Last Updated: 2024-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

671 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-13

Study Completion Date

2024-02-21

Brief Summary

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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

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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.

Conditions

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Gastritis H Pylori Gastritis Chronic Intestinal Metaplasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Normal esophagogastroduodenoscopy

Patients with normal esophagogastroduodenoscopic findings and biopsy samples were obtained.

Group Type EXPERIMENTAL

Esophagogastroduodenoscopy

Intervention Type 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

Intervention Type PROCEDURE

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

Interventions

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Esophagogastroduodenoscopy

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

Intervention Type PROCEDURE

Endoscopic biopsy sampling

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Burak Dincer

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Burak Dincer, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sisli Hamidiye Etfal Training and Research Hospital

Locations

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Sisli Hamidiye Etfal Research and Training Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Dincer B, Omeroglu S, Guven O, Yanar C, Demir U, Akgun IE. Evaluation of Antral Biopsies Obtained in Endoscopically Normal Esophagogastroduodenoscopy: A Retrospective Cohort Study. Surg Laparosc Endosc Percutan Tech. 2024 Aug 1;34(4):439-443. doi: 10.1097/SLE.0000000000001302.

Reference Type DERIVED
PMID: 38957011 (View on PubMed)

Other Identifiers

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30.01.2024-4274

Identifier Type: -

Identifier Source: org_study_id

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