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NCT00852150 Clinical Trial

Is a Reporting System for Gastritis or Duodenitis (Modified Lanza Scale) Reproducible?

Gastritis Clinical Trial

Official title:
Reproducibility of Modified Lanza Scale for the Reporting of Gastritis and Duodenitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00852150
Other study ID # HKEC 2008-083
Secondary ID
Status Completed
Phase Phase 4
First received February 25, 2009
Last updated June 5, 2012
Start date March 2009
Est. completion date December 2011

Study information
Verified date June 2012
Source Ruttonjee Hospital
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Observational

Clinical Trial Summary

The modified Lanza scale (Lanza FL, 1984) has been widely utilized to grade the degree of gastritis and duodenitis. However, the inter-rater or intra-rater reproducibility of this scale has never been validated. As a quality improvement program, it is important to study the reproducibility of the scale between different operators and the operators himself.

Method: During upper endoscopic examinations, one investigator performed the procedure and the second investigator look at the endoscopic image. The degree of gastritis and duodenitis is graded. The results of the grading are blinded to the other investigator.

The endoscopic video is stored for reassessment to determine the intra-rater reliability. The patient identifier is stored in serial number. The investigator will not retrieve the report of the first assessment during the second assessment.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility All patients undergo upper endoscopy are included after written informed consent is obtained

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
China Ruttonjee Hospital Hong Kong
China Ruttonjee Hospital Wan Chai Hong Kong

Sponsors (1)
Lead Sponsor Collaborator
Ruttonjee Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Kappa coefficient for the intra and inter-rater agreement No
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