Detection of Helicobacter Pylori Infection by High Resolution Endoscopy

Tracking Information
First Submitted Date	September 14, 2011
First Posted Date	September 15, 2011
Last Update Posted Date	April 20, 2012
Study Start Date	August 2011
Actual Primary Completion Date	January 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: April 5, 2012)	Diagnosis accuracy for predicting of Helicobacter pylori infection status [ Time Frame: 1 day ]
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT01434992 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: April 5, 2012)	Assessment of the clinicopathologic factors related to correct diagnosis [ Time Frame: 7 days ]
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Detection of Helicobacter Pylori Infection by High Resolution Endoscopy
Official Title	Detection of Helicobacter Pylori Infection by Non-magnifying High Resolution Endoscopy is Possible Within the Gastric Corpus
Brief Summary	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.
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.
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples Without DNA; Description: Gastric mucosa for detecting Helicobacter pylori
Sampling Method	Non-Probability Sample
Study Population	Patients who underwent upper endoscopy in the Kyung Hee University Hospital
Condition	Helicobacter-associated Gastritis
Intervention	Not Provided
Study Groups/Cohorts	H. pylori gastritis
Publications *	Bah A, Saraga E, Armstrong D, Vouillamoz D, Dorta G, Duroux P, Weber B, Froehlich F, Blum AL, Schnegg JF. Endoscopic features of Helicobacter pylori-related gastritis. Endoscopy. 1995 Oct;27(8):593-6.; Redéen S, Petersson F, Jönsson KA, Borch K. Relationship of gastroscopic features to histological findings in gastritis and Helicobacter pylori infection in a general population sample. Endoscopy. 2003 Nov;35(11):946-50.; Mihara M, Haruma K, Kamada T, Komoto K, Yoshihara M, Sumii K, Kajiyama G. The role of endoscopic findings for the diagnosis of Helicobacter pylori infection: evaluation in a country with high prevalence of atrophic gastritis. Helicobacter. 1999 Mar;4(1):40-8.; Cho JH, Chang YW, Jang JY, Shim JJ, Lee CK, Dong SH, Kim HJ, Kim BH, Lee TH, Cho JY. Close observation of gastric mucosal pattern by standard endoscopy can predict Helicobacter pylori infection status. J Gastroenterol Hepatol. 2013 Feb;28(2):279-84. doi: 10.1111/jgh.12046.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: April 5, 2012)	585
Original Estimated Enrollment; (submitted: September 14, 2011)	500
Actual Study Completion Date	January 2012
Actual Primary Completion Date	January 2012 (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender	Sexes Eligible for Study: All
Ages	20 Years to 70 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Korea, Republic of
Removed Location Countries
Administrative Information
NCT Number	NCT01434992
Other Study ID Numbers	KHU-HP-2011
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Jun-Hyung Cho, Kyunghee University Medical Center
Study Sponsor	Kyunghee University Medical Center
Collaborators	Not Provided
Investigators	Principal Investigator: Jun-Hyung Cho, M.D. Kyung Hee University Hospital
PRS Account	Kyunghee University Medical Center
Verification Date	April 2012