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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00852150
Recruitment Status : Completed
First Posted : February 26, 2009
Last Update Posted : June 6, 2012
Information provided by (Responsible Party):
Fook-Hong Ng, Ruttonjee Hospital

Brief 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.

Condition or disease
Gastritis Duodenitis

Study Type : Observational
Estimated Enrollment : 200 participants
Time Perspective: Prospective
Official Title: Reproducibility of Modified Lanza Scale for the Reporting of Gastritis and Duodenitis
Study Start Date : March 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Primary Outcome Measures :
  1. Kappa coefficient for the intra and inter-rater agreement

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all patient undergoing upper endoscopy after informed consent is obtained
All patients undergo upper endoscopy are included after written informed consent is obtained

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00852150

China, Hong Kong
Ruttonjee Hospital
Wan Chai, Hong Kong, China
Ruttonjee Hospital
Hong Kong, China
Sponsors and Collaborators
Ruttonjee Hospital
Principal Investigator: Fook Hong Ng, M.D. Department of Medicine, Ruttonjee Hospital

Responsible Party: Fook-Hong Ng, SMO, Ruttonjee Hospital Identifier: NCT00852150     History of Changes
Other Study ID Numbers: HKEC 2008-083
First Posted: February 26, 2009    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: June 2012

Keywords provided by Fook-Hong Ng, Ruttonjee Hospital:
inter-rater reliability
intra-rater reliablity

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Duodenal Diseases
Intestinal Diseases