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Detection of Helicobacter Pylori Infection by High Resolution Endoscopy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01434992
First Posted: September 15, 2011
Last Update Posted: April 20, 2012
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.
Information provided by (Responsible Party):
Jun-Hyung Cho, Kyunghee University Medical Center
  Purpose
Although endoscopic findings of H. pylori have been reported in the literature, there is still some debate over whether H. pylori-related gastritis can be diagnosed via endoscopic features alone. Most studies concluded that it is not possible to diagnose H. pylori-related gastritis on the basis of endoscopic findings. However, the resolution power of endoscopy has greatly improved in recent years and the exact examination of gastric mucosa was possible.

Condition
Helicobacter-associated Gastritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of Helicobacter Pylori Infection by Non-magnifying High Resolution Endoscopy is Possible Within the Gastric Corpus

Resource links provided by NLM:


Further study details as provided by Jun-Hyung Cho, Kyunghee University Medical Center:

Primary Outcome Measures:
  • Diagnosis accuracy for predicting of Helicobacter pylori infection status [ Time Frame: 1 day ]

Secondary Outcome Measures:
  • Assessment of the clinicopathologic factors related to correct diagnosis [ Time Frame: 7 days ]

Biospecimen Retention:   Samples Without DNA
Gastric mucosa for detecting Helicobacter pylori

Enrollment: 585
Study Start Date: August 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
H. pylori gastritis

Detailed Description:
Our study aimed to achieve the following: (1) describe the H. pylori-related mucosal pattern in the gastric corpus using high-definition endoscopy; (2) evaluate the diagnostic accuracy for H. pylori detection; (3) find the optimal biopsy site for rapid urease test (RUT); (4) validate the inter- and intraobserver agreement in the assessment of endoscopic patterns.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent upper endoscopy in the Kyung Hee University Hospital
Criteria

Inclusion Criteria:

  • Patients who underwent upper endoscopy

Exclusion Criteria:

  • Age < 20 or > 70
  • Severe systemic disease or advanced chronic liver disease
  • Medication history of NSAID, PPI, H2 blockers or antibiotics
  • History of H. pylori eradication therapy
  • History of gastric surgery
  • Recent history of upper GI bleeding
  • Gastric or duodenal ulcer (including old scar change) during endoscopy
  • Anemia (Hemoglobin level < 10mg/dL)
  • Pangastritis
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01434992


Locations
Korea, Republic of
Kyung Hee University Hospital
Seoul, Korea, Republic of, 82
Sponsors and Collaborators
Kyunghee University Medical Center
Investigators
Principal Investigator: Jun-Hyung Cho, M.D. Kyung Hee University Hospital
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jun-Hyung Cho, Clinical and research fellow, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT01434992     History of Changes
Other Study ID Numbers: KHU-HP-2011
First Submitted: September 14, 2011
First Posted: September 15, 2011
Last Update Posted: April 20, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Helicobacter Infections
Gastritis
Gram-Negative Bacterial Infections
Bacterial Infections
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases