Gastroesophageal Reflux DiseaseMCENCT01742377
Minimal Change Esophagitis by i-Scan Endoscopy in Dyspeptic Patients
An observational study of Gastroesophageal Reflux Disease, run by Prince of Songkla University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Patients with GerdQ positive, Patients with GerdQ negative and Normal volunteers
- Type of treatment
- Surgery or procedure
- How many people
- 174 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2010to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with dyspepsia from clinics , primary care clinics ,community.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
About this study
Official title: i-Scan Endoscopy in the Detection of Minimal Change Esophagitis in Dyspeptic Patients With or Without Gastroesophageal Reflux Disease by Gerd Q Questionnaire and by 24 Hour pH Monitoring.
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.
Read the detailed description
Background: The association of minimal change esophagitis (MCE) with gastroesophageal reflux (GERD) is controversy. High resolution endoscopy may improve the detection of minimal change lesion (MCL). i- Scan endoscopy (SE) provides high resolution images with modulation of images for a specific purpose.
Methods. All dyspeptic patients with or without GERD symptoms scheduled for endoscopy were recruited from February 2010 till July 2014. All completed the validated Thai version of GerdQ then underwent endoscopy. Forty normal volunteers were recruited for endoscopy and PHM test. The esophagus was examined by HD and SE with the TE-e mode sequentially. The captured images were independently evaluated for MCL (punctate erythema (PE), minute erosion (ME) and triangular lesion with elongated pit (EP) by three endoscopists. The agreement of > 2 endoscopists was accepted as a final result. All had PHM within 1 week after the endoscopy. GERD was diagnosed by LA grade A-D esophagitis and/or PHM with acid exposure time > the upper limit of volunteer and/or positive symptom index and/or positive Symptom Association Probability. MCE was diagnosed when PE, ME or EP or the combination of these were present.
The 40 normal volunteers were recruited for performing pH monitoring. The PHM data of 40 volunteers were analyzed to set the upper normal limit of total acid exposure time in our population. The mean + 2SD of total acid exposure time of volunteers was 1.9%.
Definition. GerdQ. The Thai version of GerdQ was translated from the English version. The contents of the GerdQ were tested by back translation from Thai to English by 5 personnel who are fluent in English and all showed the consistent contents. The reliability of the GerdQ was validated in 22 volunteers completing the questionnaire twice with 3 hours in between and showed no significant difference of the mean score (5.14+ 2.34 vs 6.23+ 1.57, p=0.07) and the number of subjects with GERD diagnosed by the GerdQ (2 vs 5, Fisher's extact test, p=0.21) .
GERD is diagnosed when total acid exposure time is more than 2% or positive symptom index (SI) or positive symptom association probability ( SAP ) or endoscopy revealed LA erosive esophagitis > grade A.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Patients with GerdQ positive, Patients with GerdQ negative, Normal volunteers
- Keywords
- GERD, Dyspepsia, Ambulatory 24-hour Esophageal pH Monitoring, Minimal change erosions
- Medical subject headings
- Gastroesophageal Reflux, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with GerdQ positiveProcedure or surgery
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 negativeProcedure or surgery
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.
Normal volunteersProcedure or surgery
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 ).
| Study group | Role | What they receive |
|---|---|---|
| Patients with GerdQ positive | Gerd Q positive was defined as score equal or more than eight. Receives: Procedure: Patients with GerdQ positive | |
| Patients with GerdQ negative | Gerd Q neegative was defined as score less than eight. Receives: Procedure: Patients with GerdQ negative | |
| Normal volunteers | Normal volunteers was defined as population without dyspeptic symptom. Receives: Procedure: Normal volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: within day of endoscopy
Secondary outcomes (3)
Number of patients with dyspepsia are diagnosed gastroesophageal reflux disease by Gerd Q.
The GerdQ score equal or more than 8 is a positive score for GERD
Measured: within the first 7 days after endoscopy
Number of patients with dyspepsia are confirmed with GERD
GERD is diagnosed when total acid exposure time is more than 2% or positive symptom index (SI) or positive symptom association probability ( SAP ) or endoscopy revealed LA erosive esophagitis > grade A .
Measured: within the first 7 days after endoscopy
Total acid exposure in normal volunteers
The mean value of total acid exposure of 40 normal volunteer.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startFeb 2010
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nisa Netinatsunton, Prince of Songkla University
- Investigators
- Dr.Nisa Netinatsunton, MD, Principal investigator, NKC Institue of Gastroenterology and Hepatology,Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742377
- Sponsor's protocol ID
- EC 53-017-21-1-2
- Acronym
- MCE
- Status last verified
- Jan 2015
- First submitted
- 28 Oct 2012
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26762316
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- i-Scan Endoscopy in the Detection of Minimal Change Esophagitis in Dyspeptic Patients With or Without Gastroesophageal Reflux Disease by Gerd Q Questionnaire and by 24 Hour pH Monitoring.
- ClinicalTrials.gov ID
- NCT01742377
- Acronym / sponsor ID
- MCE / EC 53-017-21-1-2
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD, Dyspepsia, Ambulatory 24-hour Esophageal pH Monitoring, Minimal change erosions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 5 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: The association of minimal change esophagitis (MCE) with gastroesophageal reflux (GERD) is controversy. High resolution endoscopy may improve the detection of minimal change lesion (MCL). i- Scan endoscopy (SE) provides high resolution images with modulation of images for a specific purpose.
Methods. All dyspeptic patients with or without GERD symptoms scheduled for endoscopy were recruited from February 2010 till July 2014. All completed the validated Thai version of GerdQ then underwent endoscopy. Forty normal volunteers were recruited for endoscopy and PHM test. The esophagus was examined by HD and SE with the TE-e mode sequentially. The captured images were independently evaluated for MCL (punctate erythema (PE), minute erosion (ME) and triangular lesion with elongated pit (EP) by three endoscopists. The agreement of > 2 endoscopists was accepted as a final result. All had PHM within 1 week after the endoscopy. GERD was diagnosed by LA grade A-D esophagitis and/or PHM with acid exposure time > the upper limit of volunteer and/or positive symptom index and/or positive Symptom Association Probability. MCE was diagnosed when PE, ME or EP or the combination of these were present.
The 40 normal volunteers were recruited for performing pH monitoring. The PHM data of 40 volunteers were analyzed to set the upper normal limit of total acid exposure time in our population. The mean + 2SD of total acid exposure time of volunteers was 1.9%.
Definition. GerdQ. The Thai version of GerdQ was translated from the English version. The contents of the GerdQ were tested by back translation from Thai to English by 5 personnel who are fluent in English and all showed the consistent contents. The reliability of the GerdQ was validated in 22 volunteers completing the questionnaire twice with 3 hours in between and showed no significant difference of the mean score (5.14+ 2.34 vs 6.23+ 1.57, p=0.07) and the number of subjects with GERD diagnosed by the GerdQ (2 vs 5, Fisher's extact test, p=0.21) .
GERD is diagnosed when total acid exposure time is more than 2% or positive symptom index (SI) or positive symptom association probability ( SAP ) or endoscopy revealed LA erosive esophagitis > grade A.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with GerdQ positive | – | Procedure: Patients with GerdQ positiveGerd Q positive was defined as score equal or more than eight. |
| Patients with GerdQ negative | – | Procedure: Patients with GerdQ negativeGerd Q neegative was defined as score less than eight. |
| Normal volunteers | – | Procedure: Normal volunteersNormal volunteers was defined as population without dyspeptic symptom. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with dyspepsia from clinics , primary care clinics ,community.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients with GerdQ positivePatients 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. | Procedure or surgery | Patients with GerdQ positive |
| Patients with GerdQ negativePatients 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. | Procedure or surgery | Patients with GerdQ negative |
| Normal volunteersNormal volunteers undergone EGD.The distal esophagus was examined by HD and followed by SE with a preset TE mode for esophagus ( TE-e mode ). | Procedure or surgery | Normal volunteers |
Primary outcome
Evidence of minimal change erosions detected by i-scan endoscopy.
Time frame: within day of endoscopy
Minimal change lesions (MCL) included punctate erythema (PE), minute erosion (ME) and triangular lesion with elongated pit (TLE).
3 secondary outcomes
Number of patients with dyspepsia are diagnosed gastroesophageal reflux disease by Gerd Q.
Time frame: within the first 7 days after endoscopy
Number of patients with dyspepsia are confirmed with GERD
Time frame: within the first 7 days after endoscopy
Total acid exposure in normal volunteers
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
- Derived from this study: PubMed 26762316Netinatsunton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr.Nisa Netinatsunton, MD principal investigator
NKC Institue of Gastroenterology and Hepatology,Prince of Songkla University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease, run by Prince of Songkla University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of minimal change erosions detected by i-scan endoscopy. (time frame: within day of endoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01742377, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2015.