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Detection of Helicobacter Pylori Infection by High Resolution Endoscopy

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ClinicalTrials.gov Identifier: NCT01434992
Recruitment Status : Completed
First Posted : September 15, 2011
Last Update Posted : April 20, 2012
Information provided by (Responsible Party):
Jun-Hyung Cho, Kyunghee University Medical Center

September 14, 2011
September 15, 2011
April 20, 2012
August 2011
January 2012   (Final data collection date for primary outcome measure)
Diagnosis accuracy for predicting of Helicobacter pylori infection status [ Time Frame: 1 day ]
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Complete list of historical versions of study NCT01434992 on ClinicalTrials.gov Archive Site
Assessment of the clinicopathologic factors related to correct diagnosis [ Time Frame: 7 days ]
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Detection of Helicobacter Pylori Infection by High Resolution Endoscopy
Detection of Helicobacter Pylori Infection by Non-magnifying High Resolution Endoscopy is Possible Within the Gastric Corpus
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.
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.
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Gastric mucosa for detecting Helicobacter pylori
Non-Probability Sample
Patients who underwent upper endoscopy in the Kyung Hee University Hospital
Helicobacter-associated Gastritis
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H. pylori gastritis

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
January 2012
January 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
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Jun-Hyung Cho, Kyunghee University Medical Center
Kyunghee University Medical Center
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Principal Investigator: Jun-Hyung Cho, M.D. Kyung Hee University Hospital
Kyunghee University Medical Center
April 2012