Detection of Helicobacter Pylori Infection by High Resolu... | NCT01434992

Studies
Detection of Helicobacter Pylori Infection by High Resolution Endoscopy

NCT01434992

Sponsor

Kyunghee University Medical Center

Status

Completed

Last Update Posted

Apr 20, 2012Estimated

Enrollment

585Actual

Phase

Not provided

Conditions

Helicobacter-associated Gastritis

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Sep 14, 2011

First Submission Date that Met QC Criteria

Sep 14, 2011

First Posted Date

Sep 15, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2012

Last Update Posted Date

Apr 20, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jun-Hyung Cho, Clinical and research fellow, Kyunghee University Medical CenterPrincipal Investigator

Lead Sponsor

Kyunghee University Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

585Actual

Label	Type	Description	Intervention Names
H. pylori gastritis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnosis accuracy for predicting of Helicobacter pylori infection status		1 day

Secondary Outcomes

Measure	Description	Time Frame
Assessment of the clinicopathologic factors related to correct diagnosis		7 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who underwent upper endoscopy in the Kyung Hee University Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jun-Hyung Cho, M.D.	Kyung Hee University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kyung Hee University Hospital		Seoul		82	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8608753	Background	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. doi: 10.1055/s-2007-1005764.
14606018	Background	Redeen S, Petersson F, Jonsson 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. doi: 10.1055/s-2003-43479.