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
• 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

• Duodenitis
• Gastritis

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