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
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Sponsor:
Kyunghee University Medical Center
Information provided by (Responsible Party):
Jun-Hyung Cho, Kyunghee University Medical Center
Tracking Information | ||||
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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 |
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 |
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 |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples Without DNA Description: Gastric mucosa for detecting Helicobacter pylori |
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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 * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
585 | |||
Original Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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PRS Account | Kyunghee University Medical Center | |||
Verification Date | April 2012 |