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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
  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:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by Kyunghee University Medical Center:

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

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

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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:

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
Study First Received: September 14, 2011
Last Updated: April 19, 2012
Health Authority: Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 22, 2013