Gastroesophageal Reflux DiseaseNCT00954070
Detection of Minimal Change Esophagitis Using Confocal Laser Endomicroscopy
An observational study of Gastroesophageal Reflux Disease, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
This is an observational, prospective and pilot study to determine through confocal endomicroscopy diagnostic microscopic features detectable at the gastroesophageal junction of patients with non-erosive gastroesophageal reflux disease. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Confocal endomicroscope (Pentax Model EC3870K)
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- 1 siteSingapore
- Study dates
- Aug 2009to Apr 2012
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hosipital patients with typical clinical manifestations of gastroesophageal reflux disease but no endoscopy evidence of esophagitis.
Who may be able to join
- Cases:
- male or female patients aged between 21 and 65 years with typical clinical manifestations of gastroesophageal reflux but endoscopy-negative for esophageal mucosal breaks
- by typical clinical manifestations of gastroesophageal reflux, we refer to the occurrence of heartburn and/or regurgitation more than twice a week, with a minimum duration of 8 consecutive weeks, and with symptoms severe enough to affect daily activities
- Controls:
- healthy male or female aged between 21 and 65 years who are asymptomatic for GERD and other digestive diseases
Who cannot join
- Endoscopic confirmed erosive esophagitis
- Complications such as Barrett's esophagus, gastric and/or duodenal peptic ulcer, stenosis
- Esophageal, gastric or duodenal cancer or other malignancy
- History of esophagus, stomach, or duodenum surgery
- Conditions that preclude safe biopsies (coagulopathy, haemophilia, esophageal varices, and patients on warfarin and antiplatelets)
- Scleroderma, diabetes mellitus, autonomic or peripheral neuropathy, myopathy or any underlying disease or medication that might affect the lower esophageal sphincter pressure or increase the acid clearance time
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- A history of bronchial asthma, or known allergy to fluorescein
- Pregnant or breast-feeding (for females)
- Below 21 or above 65 years of age
- Severe co-morbidities (e.g., such as end-stage renal failure, congestive cardiac failure, liver cirrhosis, severe arthritis requiring long term non-steroidal anti-inflammatory drug therapy)
- Unable or unwilling to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
This is an observational, prospective and pilot study to determine through confocal endomicroscopy diagnostic microscopic features detectable at the gastroesophageal junction of patients with non-erosive gastroesophageal reflux disease.
The hypothesis is that minimal mucosal changes occur in non-erosive gastroesophageal reflux disease. Although these minimal changes are not always visible on white-light endoscopy, it is detectable using high-resolution confocal endomicroscopy and these confocal features are diagnostic of non-erosive reflux disease (NERD).
Read the detailed description
In Asia, up to 70% of patients with typical gastroesophageal reflux symptoms could have non-erosive reflux disease (NERD), in which case, no detectable mucosal break may be observed on conventional white-light endoscopy. However, minimal change lesions are often visible upon high-resolution endoscopy and on microscopic examination of biopsied specimens. The most commonly seen microscopic features are dilated intercellular space, infiltration of inflammatory cells into squamous epithelia, hyperplasia of the epithelial basal cell and elongation of the papillae. So far, the most consistent histologic change found in NERD has been the dilated intercellular space in esophageal epithelium. But until now, determinations of intercellular space dilatations could only be done ex-vivo on biopsy specimens using transmission electron microscopy or light microscopy. With the advent of high-resolution confocal laser endomicroscopy, in-vivo determination of intercellular space dilatations and other diagnostic microscopic features could be a reality. This study is aimed at exploring such a clinical possibility and feasibility, with the intention of comparing the microscopic findings based on confocal endomicroscopy with that of symptoms, and esophageal pH.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Confocal endomicroscope (Pentax Model EC3870K)
- Keywords
- gastroesophageal reflux disease
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confocal endomicroscope (Pentax Model EC3870K)Device
Also called Pentax Model EC3870K, Pentax Corp, Tokyo, Japan
The intervention is an endoscopy procedure using a novel type of endoscope with a powerful confocal microscope attached to its tip. The endoscope (Pentax Model EC3870K) provides both white-light and confocal microscopic imaging.
| Study group | Role | What they receive |
|---|---|---|
| Case (subjects with NERD) | The investigators cases are subjects with confirmed NERD and include male or female patients aged between 21 and 65 years, who present with typical clinical manifestations of gastroesophageal reflux and have no esophageal mucosal breaks upon conventional white-light endoscopy examination but show evidence of pathologic gastroesophageal reflux on 24-hr pH monitoring. Receives: Device: Confocal endomicroscope (Pentax Model EC3870K) | |
| Control | Healthy individuals aged between 21 and 65 years who are asymptomatic for GERD and other digestive diseases Receives: Device: Confocal endomicroscope (Pentax Model EC3870K) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific microscopic changes in the esophageal mucosa as seen under the confocal endomicroscope
Measured: After 4 weeks phamacological washout period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: Difficulty in recruiting subjects for study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Medicine, National University Hospital, Singapore
- Investigators
- Khek Yu Ho, MD, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954070
- Sponsor's protocol ID
- E/09/026
- Status last verified
- Dec 2012
- First submitted
- 8 Jul 2009
- Last updated
- 28 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Barlow WJ, Orlando RC. The pathogenesis of heartburn in nonerosive reflux disease: a unifying hypothesis. Gastroenterology. 2005 Mar;128(3):771-8. doi: 10.1053/j.gastro.2004.08.014.
PubMed 15765412Calabrese C, Fabbri A, Bortolotti M, Cenacchi G, Areni A, Scialpi C, Miglioli M, Di Febo G. Dilated intercellular spaces as a marker of oesophageal damage: comparative results in gastro-oesophageal reflux disease with or without bile reflux. Aliment Pharmacol Ther. 2003 Sep 1;18(5):525-32. doi: 10.1046/j.1365-2036.2003.01713.x.
PubMed 12950425Ravelli AM, Villanacci V, Ruzzenenti N, Grigolato P, Tobanelli P, Klersy C, Rindi G. Dilated intercellular spaces: a major morphological feature of esophagitis. J Pediatr Gastroenterol Nutr. 2006 May;42(5):510-5. doi: 10.1097/01.mpg.0000215312.78664.b9.
PubMed 16707972Caviglia R, Ribolsi M, Gentile M, Rabitti C, Emerenziani S, Guarino MP, Petitti T, Cicala M. Dilated intercellular spaces and acid reflux at the distal and proximal oesophagus in patients with non-erosive gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2007 Mar 1;25(5):629-36. doi: 10.1111/j.1365-2036.2006.03237.x.
PubMed 17305764Caviglia R, Ribolsi M, Maggiano N, Gabbrielli AM, Emerenziani S, Guarino MP, Carotti S, Habib FI, Rabitti C, Cicala M. Dilated intercellular spaces of esophageal epithelium in nonerosive reflux disease patients with physiological esophageal acid exposure. Am J Gastroenterol. 2005 Mar;100(3):543-8. doi: 10.1111/j.1572-0241.2005.40978.x.
PubMed 15743349
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Minimal Change Esophagitis Using Confocal Laser Endomicroscopy
- ClinicalTrials.gov ID
- NCT00954070
- Acronym / sponsor ID
- E/09/026
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- gastroesophageal reflux disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty in recruiting subjects for study
- Enrolment
- 6 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 6 Aug 2009 (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.
This is an observational, prospective and pilot study to determine through confocal endomicroscopy diagnostic microscopic features detectable at the gastroesophageal junction of patients with non-erosive gastroesophageal reflux disease.
The hypothesis is that minimal mucosal changes occur in non-erosive gastroesophageal reflux disease. Although these minimal changes are not always visible on white-light endoscopy, it is detectable using high-resolution confocal endomicroscopy and these confocal features are diagnostic of non-erosive reflux disease (NERD).
Detailed description
In Asia, up to 70% of patients with typical gastroesophageal reflux symptoms could have non-erosive reflux disease (NERD), in which case, no detectable mucosal break may be observed on conventional white-light endoscopy. However, minimal change lesions are often visible upon high-resolution endoscopy and on microscopic examination of biopsied specimens. The most commonly seen microscopic features are dilated intercellular space, infiltration of inflammatory cells into squamous epithelia, hyperplasia of the epithelial basal cell and elongation of the papillae. So far, the most consistent histologic change found in NERD has been the dilated intercellular space in esophageal epithelium. But until now, determinations of intercellular space dilatations could only be done ex-vivo on biopsy specimens using transmission electron microscopy or light microscopy. With the advent of high-resolution confocal laser endomicroscopy, in-vivo determination of intercellular space dilatations and other diagnostic microscopic features could be a reality. This study is aimed at exploring such a clinical possibility and feasibility, with the intention of comparing the microscopic findings based on confocal endomicroscopy with that of symptoms, and esophageal pH.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case (subjects with NERD) | – | Device: Confocal endomicroscope (Pentax Model EC3870K)The investigators cases are subjects with confirmed NERD and include male or female patients aged between 21 and 65 years, who present with typical clinical manifestations of gastroesophageal reflux and have no esophageal mucosal breaks upon conventional white-light endoscopy examination but show evidence of pathologic gastroesophageal reflux on 24-hr pH monitoring. |
| Control | – | Device: Confocal endomicroscope (Pentax Model EC3870K)Healthy individuals aged between 21 and 65 years who are asymptomatic for GERD and other digestive diseases |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hosipital patients with typical clinical manifestations of gastroesophageal reflux disease but no endoscopy evidence of esophagitis.
Key inclusion criteria (5 listed)
- Cases:
- Controls:
Key exclusion criteria (11 listed)
- Endoscopic confirmed erosive esophagitis
- Complications such as Barrett's esophagus, gastric and/or duodenal peptic ulcer, stenosis
- Esophageal, gastric or duodenal cancer or other malignancy
- History of esophagus, stomach, or duodenum surgery
- Conditions that preclude safe biopsies (coagulopathy, haemophilia, esophageal varices, and patients on warfarin and antiplatelets)
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 |
|---|---|---|
| Confocal endomicroscope (Pentax Model EC3870K)Also: Pentax Model EC3870K, Pentax Corp, Tokyo, JapanThe intervention is an endoscopy procedure using a novel type of endoscope with a powerful confocal microscope attached to its tip. The endoscope (Pentax Model EC3870K) provides both white-light and confocal microscopic imaging. | Device | Case (subjects with NERD), Control |
Primary outcome
Specific microscopic changes in the esophageal mucosa as seen under the confocal endomicroscope
Time frame: After 4 weeks phamacological washout period
Results and safety
The study was stopped early (reason given: Difficulty in recruiting subjects for study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2012.
- Background: PubMed 15765412Barlow WJ, Orlando RC. The pathogenesis of heartburn in nonerosive reflux disease: a unifying hypothesis. Gastroenterology. 2005 Mar;128(3):771-8. doi: 10.1053/j.gastro.2004.08.014.
- Background: PubMed 12950425Calabrese C, Fabbri A, Bortolotti M, Cenacchi G, Areni A, Scialpi C, Miglioli M, Di Febo G. Dilated intercellular spaces as a marker of oesophageal damage: comparative results in gastro-oesophageal reflux disease with or without bile reflux. Aliment Pharmacol Ther. 2003 Sep 1;18(5):525-32. doi: 10.1046/j.1365-2036.2003.01713.x.
- Background: PubMed 16707972Ravelli AM, Villanacci V, Ruzzenenti N, Grigolato P, Tobanelli P, Klersy C, Rindi G. Dilated intercellular spaces: a major morphological feature of esophagitis. J Pediatr Gastroenterol Nutr. 2006 May;42(5):510-5. doi: 10.1097/01.mpg.0000215312.78664.b9.
- Background: PubMed 17305764Caviglia R, Ribolsi M, Gentile M, Rabitti C, Emerenziani S, Guarino MP, Petitti T, Cicala M. Dilated intercellular spaces and acid reflux at the distal and proximal oesophagus in patients with non-erosive gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2007 Mar 1;25(5):629-36. doi: 10.1111/j.1365-2036.2006.03237.x.
- Background: PubMed 15743349Caviglia R, Ribolsi M, Maggiano N, Gabbrielli AM, Emerenziani S, Guarino MP, Carotti S, Habib FI, Rabitti C, Cicala M. Dilated intercellular spaces of esophageal epithelium in nonerosive reflux disease patients with physiological esophageal acid exposure. Am J Gastroenterol. 2005 Mar;100(3):543-8. doi: 10.1111/j.1572-0241.2005.40978.x.
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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.
Khek Yu Ho, MD principal investigator
National University Hospital, Singapore
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 National University Hospital, Singapore at 1 site in Singapore.
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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 28 Dec 2012. 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 Singapore. 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 was stopped early (reason given: Difficulty in recruiting subjects for study). Results are not available in the source record.
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?
Specific microscopic changes in the esophageal mucosa as seen under the confocal endomicroscope (time frame: After 4 weeks phamacological washout period). 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 NCT00954070, which also lists 5 linked publications.
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 28 Dec 2012.