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Dysplasia Detection and Helicobacter Pylori Eradication

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03917836
Recruitment Status : Completed
First Posted : April 17, 2019
Last Update Posted : March 19, 2020
Candiolo Cancer Institute - IRCCS
Information provided by (Responsible Party):
alba panarese, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Brief 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. 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.

Condition or disease Intervention/treatment
Helicobacter Pylori Infection Diagnostic Test: endoscopy and histology

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 53 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Helicobacter Pylori Eradication Improves Endoscopic Detection Of Dysplasia On Visible Gastric Lesions In Over Middle-Aged Patients
Actual Study Start Date : May 30, 2018
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : April 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Intervention Details:
  • Diagnostic Test: endoscopy and histology
    diagnostic evaluation of chronic gastritis

Primary Outcome Measures :
  1. Rate of dysplasia before and after Helicobacter pylori eradication [ Time Frame: six months ]
    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

Secondary Outcome Measures :
  1. The prevalence concordance among the endoscopic (Kimura Takemoto grades, EGGIM scales) and histological findings (OLGA grade, OLGIM grade, dysplasia according WHO classification) [ Time Frame: six months ]
    Concordance among endoscopic and histological findings

Biospecimen Retention:   Samples Without DNA
Gastric biopsies

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients that received an endoscopic diagnosis of Helicobacter pylori-related gastritis by an expert endoscopist

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03917836

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Alba Panarese
Noci, Puglia, Italy, 70015
Sponsors and Collaborators
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Candiolo Cancer Institute - IRCCS
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Responsible Party: alba panarese, Principal investigator, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis Identifier: NCT03917836    
Other Study ID Numbers: 67/2018
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by alba panarese, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis:
Precancerous Gastric Lesions
Dysplasia Detection