Evaluation of Antral Biopsies Obtained in Normal Esophagogastroduodenoscopy

NCT06269380 | Completed

• 1 other identifier: 30.01.2024-4274
• Study Type: interventional
• Target: 671
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastritis H Pylori; Gastritis Chronic; Intestinal Metaplasia

Keywords

Esophagogastroduodenoscopy; Routine biopsy; Intestinal metaplasia

Outcome Measures

Primary Outcomes (1)

• Rate of abnormal histopathologic findings

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

  2 week after esophagogastroduodenoscopy

Secondary Outcomes (3)

• Rate of intestinal metaplasia

  2 week after esophagogastroduodenoscopy

• Rates of gastritis severity and activity

  2 week after esophagogastroduodenoscopy

• Rate of Helicobacter Pylori positivity

  2 week after esophagogastroduodenoscopy

Study Arms (1)

Normal esophagogastroduodenoscopy

EXPERIMENTAL

Patients with normal esophagogastroduodenoscopic findings and biopsy samples were obtained.

Procedure: Esophagogastroduodenoscopy; Procedure: Endoscopic biopsy sampling

Interventions

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.

Normal esophagogastroduodenoscopy

Endoscopic biopsy sampling PROCEDURE

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

Normal esophagogastroduodenoscopy

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 18-95
• Endoscopically normal esophagogastroduodenoscopy
• Sampling biopsies must be obtained

You may not qualify if:

• History of upper gastrointestinal surgery
• Abnormal endoscopic findings such as gastritis, ulcer, hiatal hernia, pyloric deformity, alkaline reflux
• Not having biopsy

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Sisli Hamidiye Etfal Research and Training Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 38957011 DERIVED

MeSH Terms

Interventions

Endoscopy, Digestive System

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Burak Dincer, M.D.

  Sisli Hamidiye Etfal Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 21, 2024
• Study Start: February 13, 2024
• Primary Completion: February 20, 2024
• Study Completion: February 21, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)