NCT00852150

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2009

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

June 6, 2012

Status Verified

June 1, 2012

Enrollment Period

2.8 years

First QC Date

February 25, 2009

Last Update Submit

June 5, 2012

Conditions

Keywords

gastritisduodenitisinter-rater reliabilityintra-rater reliablitygastroscopyduodenoscopy

Outcome Measures

Primary Outcomes (1)

  • Kappa coefficient for the intra and inter-rater agreement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Ruttonjee Hospital

Wan Chai, Hong Kong, China

Location

Ruttonjee Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

GastritisDuodenitis

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesStomach DiseasesEnteritisDuodenal DiseasesIntestinal Diseases

Study Officials

  • Fook Hong Ng, M.D.

    Department of Medicine, Ruttonjee Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
SMO

Study Record Dates

First Submitted

February 25, 2009

First Posted

February 26, 2009

Study Start

March 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

June 6, 2012

Record last verified: 2012-06

Locations