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Clinical Utility of Upper Endoscopy in Diagnosis of Helicobacter Pylori Infection

Primary Purpose

Helicobacter Pylori Infection

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
upper endoscopy
Sponsored by
Sohag University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Helicobacter Pylori Infection

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adults (≥18 years old) of both genders. Symptoms should be present within three months and have started ≥ six months before diagnosis of dyspepsia according to RomeIII criteria. Exclusion Criteria: Previous H.pylori eradication therapy. History of gastric surgery. Patients declining to provide informed consent. Pregnant and lactating women. Severe coagulopathy. liver cirrhosis, portal hypertensive gastropathy. Other causes of chronic gastritis (bile reflux gastritis, Crohn's disease, autoimmune gastritis, chemical gastritis, eosinophilic gastritis). Patients without endoscopic features or signs of gastritis.

Sites / Locations

  • Sohag University HospitalRecruiting

Outcomes

Primary Outcome Measures

The percentage of cases with H.pylori infection among all patients subjected to upper endoscopy.
Evaluate the diagnostic accuracy of I-scan technique in doagnosis of H.pylori infection

Secondary Outcome Measures

Full Information

First Posted
March 15, 2023
Last Updated
March 27, 2023
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05787262
Brief Title
Clinical Utility of Upper Endoscopy in Diagnosis of Helicobacter Pylori Infection
Official Title
Clinical Utility of Upper Endoscopy in Diagnosis of Helicobacter Pylori Infection
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Helicobacter pylori (H. pylori) is a gram-negative flagellated bacterium that inhabits the gastric environment of 60.3% of the world population, and its prevalence is particularly high in countries with inferior socioeconomic conditions, exceeding 80% in some regions of the globe , This phenomenon occurs among other reasons, due to the unsatisfactory basic sanitation and high people aggregations observed in many under developed nations, scenarios that favour the oral-oral and fecal-oral transmissions of H.pylori.Another possible transmission route of this pathogen is the sexual route. Several studies have shown that the colonization of H.pylori could be negatively and positively associated with the induction and progression of several diseases .It has been reported to be linked to gastric and duodenal ulcer, gastric carcinoma, and gastric mucosa-associated lymphoid tissue (MALT) lymphoma and gastritis ,A positive association also reported between H.pylori infection and oesophageal cancer. Moreover, evidence is also available on the positive association between H.pylori and non gastrointestinal diseases such as diabetes mellitus , coronary artery disease , and anaemia. Abdominal pain and discomfort, nausea, burping, and loss of appetite are common symptoms of H.pylori infection. Other symptoms include, bloating, weight loss, and heart burn. Several approaches are used in the detection of H. pylori. Both the invasive and the non-invasive methods are employed in the detection of H. pylori in a patient. Many factors, however, influence choices in the method of diagnosis: availability of diagnostic instruments/materials, sampling population, and competency and experience of the physicians/clinicians . Invasive methods include endoscopic evaluation, histology, rapid urease test (RUT), and bacterial culture. Non-invasive methods include urea breath test (UBT), stool antigen test (SAT), serology, and molecular diagnostic approaches .Endoscopy is an accurate test for diagnosing the infection as well as the inflammation. Endoscopy also allows the determination of the severity of gastritis with biopsies as well as the presence of ulcers, MALT lymphoma and cancer. Real-time endoscopy along with conventional white light imaging (WLI)and image enhanced endoscopic (IEE)techniques, such as narrow-band imaging (NBI), linked color imaging (LCI) and blue laser imaging (BLI), appear to have important roles in clinical practice to identify H. pyloriinfected status . Another endoscopic technique is i-scan digital chromoendoscopy, which is a digital contrast method that enhances minute mucosal structures and subtle changes in color . The overall diagnostic accuracy of i-scan is 97% compared to 78% for WLI .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
345 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
upper endoscopy
Intervention Description
Upper endoscopy , biopsy and histopathological examination of taken biopsies.
Primary Outcome Measure Information:
Title
The percentage of cases with H.pylori infection among all patients subjected to upper endoscopy.
Description
Evaluate the diagnostic accuracy of I-scan technique in doagnosis of H.pylori infection
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults (≥18 years old) of both genders. Symptoms should be present within three months and have started ≥ six months before diagnosis of dyspepsia according to RomeIII criteria. Exclusion Criteria: Previous H.pylori eradication therapy. History of gastric surgery. Patients declining to provide informed consent. Pregnant and lactating women. Severe coagulopathy. liver cirrhosis, portal hypertensive gastropathy. Other causes of chronic gastritis (bile reflux gastritis, Crohn's disease, autoimmune gastritis, chemical gastritis, eosinophilic gastritis). Patients without endoscopic features or signs of gastritis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
walaa M Omer, resident
Phone
01019614894
Email
walaamohamed@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Safaa Kh Abdallah, associate professor
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdy M Amin

12. IPD Sharing Statement

Citations:
PubMed Identifier
25582223
Citation
Chen TP, Hung HF, Chen MK, Lai HH, Hsu WF, Huang KC, Yang KC. Helicobacter Pylori Infection is Positively Associated with Metabolic Syndrome in Taiwanese Adults: a Cross-Sectional Study. Helicobacter. 2015 Jun;20(3):184-91. doi: 10.1111/hel.12190. Epub 2015 Jan 12.
Results Reference
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PubMed Identifier
30043876
Citation
Coelho LGV, Marinho JR, Genta R, Ribeiro LT, Passos MDCF, Zaterka S, Assumpcao PP, Barbosa AJA, Barbuti R, Braga LL, Breyer H, Carvalhaes A, Chinzon D, Cury M, Domingues G, Jorge JL, Maguilnik I, Marinho FP, Moraes-Filho JP, Parente JML, Paula-E-Silva CM, Pedrazzoli-Junior J, Ramos AFP, Seidler H, Spinelli JN, Zir JV. IVTH BRAZILIAN CONSENSUS CONFERENCE ON HELICOBACTER PYLORI INFECTION. Arq Gastroenterol. 2018 Apr-Jun;55(2):97-121. doi: 10.1590/S0004-2803.201800000-20. Epub 2018 Apr 16.
Results Reference
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PubMed Identifier
30893536
Citation
Crowe SE. Helicobacter pylori Infection. N Engl J Med. 2019 Mar 21;380(12):1158-1165. doi: 10.1056/NEJMcp1710945. No abstract available.
Results Reference
background
PubMed Identifier
28616085
Citation
Diaconu S, Predescu A, Moldoveanu A, Pop CS, Fierbinteanu-Braticevici C. Helicobacter pylori infection: old and new. J Med Life. 2017 Apr-Jun;10(2):112-117.
Results Reference
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Clinical Utility of Upper Endoscopy in Diagnosis of Helicobacter Pylori Infection

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