Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-02-27 @ 10:39 AM
Study NCT ID:
NCT02685150
Status:
COMPLETED
Last Update Posted:
2018-07-19
First Post:
2016-01-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Tri-Modal Imaging to Distinguish Functional Dyspepsia From Reflux Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D004415', 'term': 'Dyspepsia'}, {'id': 'D001655', 'term': 'Bile Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004383', 'term': 'Duodenogastric Reflux'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D054328', 'term': 'Proton Pump Inhibitors'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 157}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-17', 'studyFirstSubmitDate': '2016-01-19', 'studyFirstSubmitQcDate': '2016-02-17', 'lastUpdatePostDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numbers of participants with abnormal endoscopic findings and positive Omeprazole tests', 'timeFrame': 'one month', 'description': 'Numbers of participants with abnormal endoscopic findings are used to calculate the diagnostic Value of Endoscopic Tri-Modal Imaging in Distinguishing Functional Dyspepsia and Reflux Disease, including specificity, sensitivity and accuracy.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Endoscopic Tri-Modal Imaging', 'Gastric juice', 'Functional dyspepsia', 'Acid reflux disease', 'Bile reflux'], 'conditions': ['Gastroesophageal Reflux Disease', 'Dyspepsia', 'Bile Reflux']}, 'referencesModule': {'references': [{'pmid': '23644963', 'type': 'BACKGROUND', 'citation': 'Talley NJ. Functional (non-ulcer) dyspepsia and gastroesophageal reflux disease: one not two diseases? Am J Gastroenterol. 2013 May;108(5):775-7. doi: 10.1038/ajg.2013.102.'}, {'pmid': '25587615', 'type': 'RESULT', 'citation': 'Wang W, Uedo N, Yang Y, Peng L, Bai D, Lu Z, Fan K, Wang J, Wang X, Zhao Y, Yu Z. Autofluorescence imaging endoscopy for predicting acid reflux in patients with gastroesophageal reflux disease. J Gastroenterol Hepatol. 2014;29(7):1442-8. doi: 10.1111/jgh.12566. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Endoscopic Tri-Modal Imaging which combines Narrow-band Imaging(NBI), Autofluorescence Imaging (AFI) and White-light Imaging (WLI) could be used to identify the indistinct changes in the gut caused by reflux disease,either acid reflux or bile reflux, which make it possible to differentiate reflux disease from functional dyspepsia (FD).', 'detailedDescription': 'Functional dyspepsia (FD) and acid/bile reflux disease are common. These diseases share similar clinical manifestations. Individuals with functional dyspepsia (FD) often present upper abdominal pain or discomfort, bloating, early satiety, loss of appetite, and no organic factors underlie it. Individuals suffering from acid/bile reflux disease often complain heartburn, upper abdominal burning or discomfort. What is more, there are always no specific changes on traditional endoscopy that can be used to differentiate these diseases (except erosive esophagitis). Though proton-pump inhibitor (PPI) test is frequently applied to confirm the diagnosis of acid reflux disease, but certain amounts of individuals with gastroesophageal reflux disease (GERD) do not show favorable response to PPI test. In order to make a distinction of these diseases, esophageal pH-metry is needed, however it is not always available in most clinics. Recent data showed that new endoscopic technology such as Endoscopic Tri-Modal Imaging could demonstrate indistinct lesions caused by GERD which are not detectable by standard endoscopy, subsequently improve endoscopic diagnosis of these diseases. In addition, simultaneous analysis of gastric juice can help to determine whether bile reflux is present or not. As it is known, pathologic refluxes underlie not functional dyspepsia but acid/bile reflux disease. Hence, it is hypothesized that Endoscopic Tri-Modal Imaging in combination with simultaneous analysis of gastric juice could be used to differentiate functional dyspepsia from acid/bile reflux disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* symptoms suggestive of GERD or dyspepsia.\n* Presence of symptom for longer than 6 month\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Any known upper GI disease, other than reflux esophagitis\n* Active or healing gastroduodenal ulcer (except scars)\n* History of esophageal or gastric surgery.\n* Clinically significant heart, lung, liver or kidney disease\n* Allergy to proton-pump inhibitor\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02685150', 'briefTitle': 'Endoscopic Tri-Modal Imaging to Distinguish Functional Dyspepsia From Reflux Disease', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'The Role of Endoscopic Tri-Modal Imaging in Distinguishing Functional Dyspepsia From Reflux Disease', 'orgStudyIdInfo': {'id': 'S2015-086-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Functional dyspepsia', 'description': 'Participants are to undergo Endoscopic Tri-Modal Imaging, Omeprazole test and Analysis of gastric juice and those who fulfill with Rome III criteria for functional dyspepsia are to be classified into this group.', 'interventionNames': ['Device: Endoscopic Tri-Modal Imaging', 'Drug: Omeprazole', 'Other: Analysis of gastric juice']}, {'type': 'EXPERIMENTAL', 'label': 'Acid reflux disease', 'description': 'Participants are to undergo Endoscopic Tri-Modal Imaging, Omeprazole test and Analysis of gastric juice. Participants with acid reflux are to confirmed by Omeprazole test, one kind of proton-pump inhibitor (PPI) tests.', 'interventionNames': ['Device: Endoscopic Tri-Modal Imaging', 'Drug: Omeprazole', 'Other: Analysis of gastric juice']}, {'type': 'EXPERIMENTAL', 'label': 'Bile reflux disease', 'description': 'Participants are to undergo Endoscopic Tri-Modal Imaging and Analysis of gastric juice. Participants with bile reflux are to be confirmed by Analysis of gastric juice.', 'interventionNames': ['Device: Endoscopic Tri-Modal Imaging', 'Other: Analysis of gastric juice']}, {'type': 'EXPERIMENTAL', 'label': 'Health volunteers', 'description': 'Health volunteers for routine checkup. Participants are to undergo Endoscopic Tri-Modal Imaging as well as Analysis of gastric juice and those who show no abnormal findings are to be classified into this group.', 'interventionNames': ['Device: Endoscopic Tri-Modal Imaging', 'Other: Analysis of gastric juice']}], 'interventions': [{'name': 'Endoscopic Tri-Modal Imaging', 'type': 'DEVICE', 'description': 'Endoscope that combines white light imaging (WLI) with autofluorescence imaging (AFI) and narrow band imaging (NBI).', 'armGroupLabels': ['Acid reflux disease', 'Bile reflux disease', 'Functional dyspepsia', 'Health volunteers']}, {'name': 'Omeprazole', 'type': 'DRUG', 'otherNames': ['proton-pump inhibitor (PPI)'], 'description': 'Omeprazole is one kind of proton-pump inhibitors. All participants undergo standard proton-pump inhibitor (PPI) tests for two weeks with Omeprazole, 20mg twice a day.', 'armGroupLabels': ['Acid reflux disease', 'Functional dyspepsia']}, {'name': 'Analysis of gastric juice', 'type': 'OTHER', 'otherNames': ['Routine,biochemical, microbiological analysis'], 'description': 'Analysis of gastric juice including routine, biochemical and microbiological analysis.', 'armGroupLabels': ['Acid reflux disease', 'Bile reflux disease', 'Functional dyspepsia', 'Health volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'country': 'China', 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Guoquan Ren, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Chinese PLA General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data are available from the W Wang, MD.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Weifeng Wang, MD', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}