Gastritis H PyloriNCT06269380
Evaluation of Antral Biopsies Obtained in Normal Esophagogastroduodenoscopy
A study testing Esophagogastroduodenoscopy and Endoscopic biopsy sampling in people with Gastritis H Pylori and Gastritis Chronic, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Gastritis H Pylori, Gastritis Chronic, Intestinal Metaplasia
- What is being tested?
- Esophagogastroduodenoscopy and Endoscopic biopsy sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 671 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Feb 2024to 21 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18-95
- Endoscopically normal esophagogastroduodenoscopy
- Sampling biopsies must be obtained
Who cannot join
- History of upper gastrointestinal surgery
- Abnormal endoscopic findings such as gastritis, ulcer, hiatal hernia, pyloric deformity, alkaline reflux
- Not having biopsy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sisli Hamidiye Etfal Research and Training Hospital
Istanbul
About this study
Official title: Evaluation of Antral Biopsies Obtained in Normal Esophagogastroduodenoscopy: A Retrospective Cohort Study
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.
Read the 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.
- Conditions
- Gastritis H Pylori, Gastritis Chronic, Intestinal Metaplasia
- Being tested
- Esophagogastroduodenoscopy, Endoscopic biopsy sampling
- Keywords
- Esophagogastroduodenoscopy, Routine biopsy, Intestinal metaplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsophagogastroduodenoscopyProcedure or surgery
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 samplingProcedure or surgery
The obtaining of biopsy samples for control purposes despite the absence of endoscopic pathology during esophagogastroduodenoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Normal esophagogastroduodenoscopy | Experimental | Patients with normal esophagogastroduodenoscopic findings and biopsy samples were obtained. Receives: Procedure: Esophagogastroduodenoscopy; Procedure: Endoscopic biopsy sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of abnormal histopathologic findings
Rate of abnormal histopathologic findings in patients with normal esophagogastroduodenoscopy and sampling biopsies obtained
Measured: 2 week after esophagogastroduodenoscopy
Secondary outcomes (3)
Rate of intestinal metaplasia
Rate of intestinal metaplasia in patients with normal esophagogastroduodenoscopy and sampling biopsies obtained
Measured: 2 week after esophagogastroduodenoscopy
Rates of gastritis severity and activity
Rate of gastritis severity and activity in patients with normal esophagogastroduodenoscopy and sampling biopsies obtained
Measured: 2 week after esophagogastroduodenoscopy
Rate of Helicobacter Pylori positivity
Rate of Helicobacter Pylori positivity in patients with normal esophagogastroduodenoscopy and sampling biopsies obtained
Measured: 2 week after esophagogastroduodenoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start13 Feb 2024
- Primary completion20 Feb 2024
- Study completion21 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastritis H PyloriStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 671 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Dincer, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Burak Dincer, M.D., Principal investigator, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269380
- Sponsor's protocol ID
- 30.01.2024-4274
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38957011
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Antral Biopsies Obtained in Normal Esophagogastroduodenoscopy: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06269380
- Acronym / sponsor ID
- 30.01.2024-4274
- Conditions
- Gastritis H Pylori, Gastritis Chronic, Intestinal Metaplasia
- Keywords
- Esophagogastroduodenoscopy, Routine biopsy, Intestinal metaplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 671 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 21 Feb 2024 (actual)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Normal esophagogastroduodenoscopy | Experimental | Procedure: Esophagogastroduodenoscopy, Procedure: Endoscopic biopsy samplingPatients with normal esophagogastroduodenoscopic findings and biopsy samples were obtained. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged between 18-95
- Endoscopically normal esophagogastroduodenoscopy
- Sampling biopsies must be obtained
Key exclusion criteria (3 listed)
- History of upper gastrointestinal surgery
- Abnormal endoscopic findings such as gastritis, ulcer, hiatal hernia, pyloric deformity, alkaline reflux
- Not having biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsophagogastroduodenoscopyDuring the procedure, endoscopic examination of the upper gastrointestinal tract was made. Biopsy sampling can be made during procedure if endoscopist deemed necessary. | Procedure or surgery | Normal esophagogastroduodenoscopy |
| Endoscopic biopsy samplingThe obtaining of biopsy samples for control purposes despite the absence of endoscopic pathology during esophagogastroduodenoscopy. | Procedure or surgery | Normal esophagogastroduodenoscopy |
Primary outcome
Rate of abnormal histopathologic findings
Time frame: 2 week after esophagogastroduodenoscopy
Rate of abnormal histopathologic findings in patients with normal esophagogastroduodenoscopy and sampling biopsies obtained
3 secondary outcomes
Rate of intestinal metaplasia
Time frame: 2 week after esophagogastroduodenoscopy
Rates of gastritis severity and activity
Time frame: 2 week after esophagogastroduodenoscopy
Rate of Helicobacter Pylori positivity
Time frame: 2 week after esophagogastroduodenoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Derived from this study: PubMed 38957011Dincer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Burak Dincer, M.D. principal investigator
Sisli Hamidiye Etfal Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophagogastroduodenoscopy and Endoscopic biopsy sampling in people with Gastritis H Pylori and Gastritis Chronic, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of abnormal histopathologic findings (time frame: 2 week after esophagogastroduodenoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06269380, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.