NCT01742377

Brief Summary

The purpose of this study to assess efficacy of SE endoscopy in the detection of MCE in dyspeptic patients with or without GERD diagnosed by GerdQ or by endoscopy + PHM and in normal volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
174

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 1, 2010

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 5, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

April 14, 2015

Status Verified

January 1, 2015

Enrollment Period

4.4 years

First QC Date

October 28, 2012

Last Update Submit

April 11, 2015

Conditions

Gastroesophageal Reflux Disease

Keywords

GERDDyspepsiaAmbulatory 24-hour Esophageal pH MonitoringMinimal change erosions

Outcome Measures

Primary Outcomes (1)

  • Evidence of minimal change erosions detected by i-scan endoscopy.

    Minimal change lesions (MCL) included punctate erythema (PE), minute erosion (ME) and triangular lesion with elongated pit (TLE).

    within day of endoscopy

Secondary Outcomes (3)

  • Number of patients with dyspepsia are diagnosed gastroesophageal reflux disease by Gerd Q.

    within the first 7 days after endoscopy

  • Number of patients with dyspepsia are confirmed with GERD

    within the first 7 days after endoscopy

  • Total acid exposure in normal volunteers

    1 day

Study Arms (3)

Patients with GerdQ positive

Gerd Q positive was defined as score equal or more than eight.

Procedure: Patients with GerdQ positive

Patients with GerdQ negative

Gerd Q neegative was defined as score less than eight.

Procedure: Patients with GerdQ negative

Normal volunteers

Normal volunteers was defined as population without dyspeptic symptom.

Procedure: Normal volunteers

Interventions

Patients with GerdQ positivePROCEDURE

Patients done GerdQ questionnaire, then undergone EGD. The distal esophagus was examined by HD and followed by SE with a preset TE mode for esophagus ( TE-e mode ). All patients had pH monitoring study within 1 week after the endoscopy.

Patients with GerdQ positive
Patients with GerdQ negativePROCEDURE

Patients done GerdQ questionnaire, then undergone EGD. The distal esophagus was examined by HD and followed by SE with a preset TE mode for esophagus ( TE-e mode ). All patients had pH monitoring study within 1 week after the endoscopy.

Patients with GerdQ negative
Normal volunteersPROCEDURE

Normal volunteers undergone EGD.The distal esophagus was examined by HD and followed by SE with a preset TE mode for esophagus ( TE-e mode ).

Normal volunteers

Eligibility Criteria

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

Patients with dyspepsia from clinics , primary care clinics ,community.

You may qualify if:

  • Patients with one or more of the following symptoms namely epigastric pain or discomfort, postprandial fullness and early satiety with or without symptoms suggesting GERD
  • Patients able to give informed consent

You may not qualify if:

  • Patients with significant weight loss.
  • Patients with hematemesis, melena ,dysphagia, intractable vomiting , palpable abdominal mass.
  • Patients with history of documented peptic ulcer , gastric surgery , gastric cancer.
  • Patients with symptoms compatible with irritable bowel syndrome, hepatobiliary tract disease.
  • Patients with severe concomitant medical conditions, pregnant woman or continuous usage of steroids or NSIADS in the preceding 1 month before entry to the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Related Publications (1)

  • Netinatsunton N, Sottisuporn J, Attasaranya S, Witeerungrot T, Chamroonkul N, Jongboonyanuparp T, Geater A, Ovartlarnporn B. i-Scan detection of minimal change esophagitis in dyspeptic patients with or without Gastroesophageal Reflux disease. BMC Gastroenterol. 2016 Jan 14;16:4. doi: 10.1186/s12876-016-0417-4.

    PMID: 26762316DERIVED

MeSH Terms

Conditions

Gastroesophageal RefluxDyspepsia

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dr.Nisa Netinatsunton, MD

    NKC Institue of Gastroenterology and Hepatology,Prince of Songkla University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
NKC Institute of Gastrornterology and Hepatology

Study Record Dates

First Submitted

October 28, 2012

First Posted

December 5, 2012

Study Start

February 1, 2010

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

April 14, 2015

Record last verified: 2015-01

Locations

TH(1)