Dysplasia Detection and Helicobacter Pylori Eradication

NCT03917836 | Completed

• 1 other identifier: 67/2018
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection

Keywords

Precancerous Gastric Lesions; Dysplasia Detection

Outcome Measures

Primary Outcomes (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

  six months

Secondary Outcomes (1)

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

  six months

Interventions

endoscopy and histology DIAGNOSTIC_TEST

diagnostic evaluation of chronic gastritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: lead
• Candiolo Cancer Institute - IRCCS: collaborator

Study Sites (1)

Alba Panarese

Noci, Apulia, 70015, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gastric biopsies

MeSH Terms

Interventions

Endoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 13, 2019
• First Posted: April 17, 2019
• Study Start: May 30, 2018
• Primary Completion: November 30, 2018
• Study Completion: April 10, 2019
• Last Updated: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)