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Detection of Helicobacter Pylori Infection by High Resolution Endoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jun-Hyung Cho, Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT01434992
First received: September 14, 2011
Last updated: April 19, 2012
Last verified: April 2012
History of Changes

September 14, 2011
April 19, 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 ] [ Designated as safety issue: Yes ]
Not Provided
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 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
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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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Gastric mucosa for detecting Helicobacter pylori
Non-Probability Sample
Patients who underwent upper endoscopy in the Kyung Hee University Hospital
Helicobacter-associated Gastritis
Not Provided
H. pylori gastritis

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
585
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
Both
20 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01434992
KHU-HP-2011
Yes
Not Provided
Not Provided
Jun-Hyung Cho, Kyunghee University Medical Center
Kyunghee University Medical Center
Not Provided
Principal Investigator: Jun-Hyung Cho, M.D. Kyung-Hee University Hospital
Kyunghee University Medical Center
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP