Detection of Helicobacter Pylori Infection by High Resolution Endoscopy

NCT01434992 | Completed DMC

• 1 other identifier: KHU-HP-2011
• Study Type: observational
• Target: 585
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter-associated Gastritis

Outcome Measures

Primary Outcomes (1)

• Diagnosis accuracy for predicting of Helicobacter pylori infection status

  1 day

Secondary Outcomes (1)

• Assessment of the clinicopathologic factors related to correct diagnosis

  7 days

Study Arms (1)

H. pylori gastritis

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent upper endoscopy in the Kyung Hee University Hospital

You may qualify if:

• Patients who underwent upper endoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyunghee University Medical Center: lead

Study Sites (1)

Kyung Hee University Hospital

Seoul, 82, South Korea

Location

Related Publications (4)

• 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.

  PMID: 8608753 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.

  PMID: 14606018 BACKGROUND

• 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. doi: 10.1046/j.1523-5378.1999.09016.x.

  PMID: 10352086 BACKGROUND

• 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.

  PMID: 23189930 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gastric mucosa for detecting Helicobacter pylori

Study Officials

• Jun-Hyung Cho, M.D.

  Kyung Hee University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical and research fellow

Study Record Dates

• First Submitted: September 14, 2011
• First Posted: September 15, 2011
• Study Start: August 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: April 20, 2012

Record last verified: 2012-04

Locations

KR (1)