NCT01504971

Brief Summary

Aim of this study is to compare the efficacy of narrow band imaging (NBI) and autofluorescence imaging (AFI) to distinguish subtle mucosal change related to acid reflux that is not visible in standard white light imaging (WLI) endoscopy, and help indicating the diagnosis of gastroesophageal reflux disease (GERD).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

September 2, 2015

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 2, 2015

Status Verified

August 1, 2015

Enrollment Period

1.4 years

First QC Date

January 4, 2012

Results QC Date

August 4, 2015

Last Update Submit

August 4, 2015

Conditions

Gastroesophageal Reflux Disease

Keywords

Gastroesophageal Reflux;Endoscopy;Esophageal pH monitoring;Narrow band imaging;Autofluorescence imaging;White light imaging;

Outcome Measures

Primary Outcomes (1)

  • Diagnostic Ability of Each Endoscopic Finding for GERD Symptom.

    Patients with GERD symptom receive endoscopic tri-modal imaging within 1 month

    1 month

Secondary Outcomes (3)

  • Association of Each Endoscopic Finding With Symptom Score

    1 month

  • Association of Each Endoscopic Finding With pH Monitoring Result

    1 month

  • Association of Each Endoscopic Finding With Treatment Effect of PPI

    2 month

Study Arms (1)

Gastroesophageal reflux disease (GERD)

Other: symptom questionaireProcedure: pH monitoringProcedure: Tri-modal imaging endoscopyDrug: rabeprazole

Interventions

symptom questionaireOTHER

GerdQ questionaire

Also known as: GERD symptom questionaire
Gastroesophageal reflux disease (GERD)
pH monitoringPROCEDURE

24-hour pH monitoring

Also known as: Device was from Sierra Company
Gastroesophageal reflux disease (GERD)
Tri-modal imaging endoscopyPROCEDURE

To investigate WLI,NBI and AFI

Also known as: Device was from Olympus Company
Gastroesophageal reflux disease (GERD)
rabeprazoleDRUG

10mg, bid, p.o.

Also known as: PPI therapy
Gastroesophageal reflux disease (GERD)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients presented with reflux symptoms in outpatient clinic of a general hospital.

You may qualify if:

  • GERD symptom: heartburn or regurgitation (either one) at least 2 days a week
  • Presence of symptom for longer than 1 month before screening
  • Provision of written informed consent

You may not qualify if:

  • Any known esophageal disease or disorder, other than reflux esophagitis
  • Active or healing gastroduodenal ulcer (except scars)
  • History of esophageal or gastric surgery.
  • Clinically significant heart, lung, liver or kidney disease
  • Allergy to proton-pump inhibitor
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient Department Building

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (1)

  • Fock KM, Teo EK, Ang TL, Tan JY, Law NM. The utility of narrow band imaging in improving the endoscopic diagnosis of gastroesophageal reflux disease. Clin Gastroenterol Hepatol. 2009 Jan;7(1):54-9. doi: 10.1016/j.cgh.2008.08.030. Epub 2008 Sep 3.

    PMID: 18852068RESULT

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Dr. Weifeng Wang
Organization
ChinaPLAGH
wangwf301@hotmail.com
0086-13911952018

Study Officials

  • Shuzhang Li, MD

    Chinese PLA General Hospital

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Gastroenterology and Hepatology

Study Record Dates

First Submitted

January 4, 2012

First Posted

January 6, 2012

Study Start

January 1, 2011

Primary Completion

June 1, 2012

Study Completion

December 1, 2016

Last Updated

September 2, 2015

Results First Posted

September 2, 2015

Record last verified: 2015-08

Locations

CN(1)