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

Tracking Information

First Received Date ^ICMJE

September 14, 2011

Last Updated Date

April 19, 2012

Start Date ^ICMJE

August 2011

Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01434992 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Detection of Helicobacter Pylori Infection by High Resolution Endoscopy

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Design ^ICMJE

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 ^ICMJE

Helicobacter-associated Gastritis

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

H. pylori gastritis

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

585

Completion Date

January 2012

Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01434992

Other Study ID Numbers ^ICMJE

KHU-HP-2011

Has Data Monitoring Committee

Yes

Responsible Party

Jun-Hyung Cho, Kyunghee University Medical Center

Study Sponsor ^ICMJE

Kyunghee University Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jun-Hyung Cho, M.D.

Kyung-Hee University Hospital

Information Provided By

Kyunghee University Medical Center

Verification Date

April 2012

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

To Top