AzTrials
AzTrials

Helicobacter Pylori InfectionNCT03917836

Dysplasia Detection and Helicobacter Pylori Eradication

An observational study of Helicobacter Pylori Infection, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The investigators in the present study, aimed to assess the efficacy of both White-Light Endoscopy with High Resolution Endoscopy-Narrow-band imaging in the diagnosis of Premalignant Gastric Conditions, before and after Helicobacter pylori-eradication. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Helicobacter Pylori Infection
What is being tested?
endoscopy and histology
How many people
53 participants
Where
1 siteItaly
Study dates
30 May 2018to 10 Apr 2019
How long will I take part?
6 Months
Phase
Observational
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: patients that received an endoscopic diagnosis of Helicobacter pylori-related gastritis by an expert endoscopist

Who may be able to join

  • HP-related symptoms
  • Gastritis with/without PGC by gastric biopsies and/or by non-invasive tests

Who cannot join

  • Absence of informed consent
  • Past gastric cancer or gastric related surgery
  • Not being able to perform at least five biopsies during the endoscopic exam
  • Relevant comorbidities (such as cardiac, respiratory, chronic renal insufficiency, chronic liver disease, psychiatric conditions, anticoagulant therapy or coagulation disorders)

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Alba Panarese

    Noci, Apulia, 70015

Other trials in Italy

About this study

Official title: Helicobacter Pylori Eradication Improves Endoscopic Detection Of Dysplasia On Visible Gastric Lesions In Over Middle-Aged Patients

The investigators in the present study, aimed to assess the efficacy of both White-Light Endoscopy with High Resolution Endoscopy-Narrow-band imaging in the diagnosis of Premalignant Gastric Conditions, before and after Helicobacter pylori-eradication. A prospective study was performed in our institution involving the regular use of high resolution gastroscopes with and without Narrow-band imaging. From May 2018 to April 2019, all patients that received an endoscopic diagnosis of Helicobacter pylori-related gastritis with/without Premalignant Gastric Conditions by an expert endoscopist, were reassessed by White-Light Endoscopy and High Resolution Endoscopy-Narrow-band imaging, including biopsy samples according to the Sydney system, six months later after the proved Helicobacter pylori-eradication.

Read the detailed description

Helicobacter pylori infection is commonly responsible for Premalignant Gastric Conditions such as chronic atrophic gastritis and Intestinal Metaplasia, which are strongly associated, when located in antrum and corpus, to the evolution into dysplasia and into the Lauren intestinal-type of Gastric Carcinoma.

Many studies have linked gastric carcinogenesis to genes, genetic variations of the host, as well as to Helicobacter pylori induced inflammation of gastric mucosa. In addition, hostile Helicobacter pylori strains have been considered responsible for more severe degrees of inflammation and more rapid progression to intestinal-type gastric cancer, in genetically predisposed subjects. Nowadays, Premalignant Gastric Conditions detection and surveillance has been considered a cost-effective strategy only in intermediate or high risk regions, for the prevention of high-grade dysplasia and gastric cancer. Anyway, conflicting results deriving from "long-term" endoscopic surveillances (ranging between 2-16 years), have shown that Helicobacter pylori eradication was effective in reducing the prevalence of advanced-Premalignant Gastric Conditions, as well as histological progression of early-Premalignant Gastric Conditions, decreasing gastric cancer incidence. The current European guidelines recommend Helicobacter pylori eradication in at high-risk subjects.

Nevertheless, even after Helicobacter pylori eradication, the risk for Premalignant Gastric Conditions/malignant lesions progresses on long-term follow-up. An adequate upper gastrointestinal endoscopy should include at least four non-targeted biopsies at the lesser and greater curvature, and at the antrum-corpus for Helicobacter pylori infection diagnosis and for the optimal detection/staging of advanced-Premalignant Gastric Conditions, which are randomly distributed throughout the stomach. Additional target biopsies of visible suspected lesions are recommended, since low/high grade dysplasia may appear as endoscopically evident, depressed or raised lesions. Several studies showed that Magnification Chromoendoscopy and Narrow-band imaging with or without magnification could be more accurate than White-Light Endoscopy alone, when performed by expert endoscopists, in diagnosing and differentiating Premalignant Gastric Conditions/lesions, by guiding biopsies for staging atrophic/metaplastic changes and by targeting neoplastic lesions, even if random biopsies may be useful in detecting some cases undetectable by Narrow-band imaging alone, and therefore both White-Light Endoscopy with Narrow-band imaging are suggested. Therefore, as a result of many studies, high definition endoscopy with Chromoendoscopy is considered better than high definition White-Light Endoscopy alone in diagnosing Premalignant Gastric Conditions and early neoplastic lesions, whereas virtual Chromoendoscopy, with or without magnification, should be used for the diagnosis of Premalignant Gastric Conditions. For patients with indefinite diagnosis for dysplasia, or with dysplasia resulted from random biopsies without "apparent" endoscopically visible lesions, the current guidelines suggest a relatively immediate endoscopic reassessment with High Resolution Endoscopy-Narrow-band imaging, to exclude a misdiagnosed low/high grade dysplasia on visible lesion or an early-gastric cancer, differently from the previous guidelines, which advised for the same patients only endoscopic follow-up within 1 year after diagnosis.

Being tested
endoscopy and histology
Keywords
Precancerous Gastric Lesions, Dysplasia Detection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • endoscopy and histologyDiagnostic test

    diagnostic evaluation of chronic gastritis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of dysplasia before and after Helicobacter pylori eradication

    diagnostic performance of High Resolution Wight Light Endoscopy with High Resolution Endoscopy Narrow Band Imaging, in detecting Precancerous Gastric Conditions on an interim endoscopic surveillance

    Measured: six months

Secondary outcomes (1)
  1. The prevalence concordance among the endoscopic (Kimura Takemoto grades, EGGIM scales) and histological findings (OLGA grade, OLGIM grade, dysplasia according WHO classification)

    Concordance among endoscopic and histological findings

    Measured: six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2019
  2. Study start30 May 2018
  3. Primary completion30 Nov 2018
  4. Study completion10 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
53 participants (actual)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03917836
Sponsor's protocol ID
67/2018
Status last verified
Mar 2020
First submitted
13 Apr 2019
Last updated
19 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Helicobacter Pylori Infection, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.

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 2 inclusion and 4 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 19 Mar 2020. 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 Italy. 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 dysplasia before and after Helicobacter pylori eradication (time frame: six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 19 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in