Ignite Creation Date:
2025-12-17 @ 2:50 PM
Ignite Modification Date:
2025-12-23 @ 8:39 PM
Study NCT ID:
NCT00487695
Status:
COMPLETED
Last Update Posted:
2021-06-22
First Post:
2007-06-18
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Confocal Endomicroscopy for Barrett's Esophagus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001471', 'term': 'Barrett Esophagus'}, {'id': 'C562730', 'term': 'Adenocarcinoma Of Esophagus'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016145', 'term': 'Endoscopy, Digestive System'}], 'ancestors': [{'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mcanto@jhmi.edu', 'phone': '410-614-5388', 'title': 'Dr. Marcia Canto.', 'organization': 'Johns Hopkins University School of Medicine Division of Gastroenterology and Hepatology'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Relatively small study (39 patients) and performed at a tertiary care, referral center, which can reduce generalizability.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected after each procedure and for an average of one month after the last procedure.', 'eventGroups': [{'id': 'EG000', 'title': 'Confocal Laser Endomicroscopy', 'description': 'Adverse even reporting is being done by procedure type (ie confocal laser endomicroscopy vs. standard endoscopy)', 'otherNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Standard EGD', 'description': 'Adverse even reporting is being done by procedure type (ie confocal laser endomicroscopy vs. standard endoscopy)', 'otherNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'post-procedure pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Diagnostic Yield for Neoplasia in High Risk Patients(Suspected Neoplasia)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Confocal Laser Endomicroscopy', 'description': 'all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.'}, {'id': 'OG001', 'title': 'Standard Endoscopy', 'description': 'all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'spread': '0', 'groupId': 'OG000'}, {'value': '17', 'spread': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Our hypothesis was that the yield for neoplasia would be higher using confocal laser endomicroscopy compared to standard endoscopy. The null hypothesis would be that there is no difference in yield for neoplasia when CLE is used compared to standard endoscopy. We estimated that the yield for neoplasia would increase from 10% to 40% using CLE and the calculated sample size was 37. We planned to enroll 48 patients to allow for possible dropouts.', 'statisticalMethod': 'Wilcoxon signed rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': 'The yield for neoplasia is calculated by the number of biopsies showing neoplasia over the total number of biopsies taken (normal + neoplastic biopsies)', 'unitOfMeasure': 'percent yield for neoplasia', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was per protocol as the patients who did not undergo CLE could not be analyzed at all (cannot compare 2 procedures when only one (or zero) are performed. This analysis looks specifically at patients with Barrett's and suspected (but not known) neoplasia."}, {'type': 'SECONDARY', 'title': 'Mean Number of Biopsies With Neoplasia in High Risk Patients (Suspected Neoplasia)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Confocal Laser Endomicroscopy', 'description': 'all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.'}, {'id': 'OG001', 'title': 'Standard Endoscopy', 'description': 'all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '15'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '19'}]}]}], 'analyses': [{'pValue': '0.89', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The number of biopsies showing neoplasia was determined for each procedure (confocal laser endomicroscopy, standard EGD). These were compared.', 'statisticalMethod': 'Wilcoxon signed-rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': "The number of biopsies from each procedure (i.e. biopsies taken during CLE, or biopsies taken during standard EGD) that showed neoplasia. Neoplasia is high grade dysplasia or cancer. This analysis looks at patients with Barrett's suspected (but not known) neoplasia.", 'unitOfMeasure': 'mean number of biopsies with neoplasia', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was per protocol. Each participant was compared to self, so if the participant did not complete the study, no comparison could be made.'}, {'type': 'SECONDARY', 'title': 'Mean Number of Biopsies Taken in High Risk Patients (Suspected Neoplasia)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Confocal Laser Endomicroscopy', 'description': 'all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.'}, {'id': 'OG001', 'title': 'Standard Endoscopy', 'description': 'all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '22'}, {'value': '23.7', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '41'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The null hypothesis would be that CLE does not decrease the number of biopsies needed to make a diagnosis compared to standard endoscopy', 'statisticalMethod': 'wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': "The number of biopsies taken during each procedure (i.e. the number of biopsies taken during CLE, or the number of biopsies taken during standard EGD). Biopsies are taken during CLE only if CLE shows that the esophageal mucosa is abnormal. Esophageal biopsies are taken during standard EGD using a standard Barrett's esophagus protocol (4 quadrants, every 1-2 cm of the Barrett's esophagus). This analysis looks at the Barrett's patients with suspected (but not known) neoplasia.", 'unitOfMeasure': 'mean number of biopsies', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol as participants would only have data to compare if they completed both endoscopies'}, {'type': 'SECONDARY', 'title': "Diagnostic Yield for Neoplasia in Barrett's Surveillance Patients", 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Confocal Laser Endomicroscopy', 'description': 'all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.'}, {'id': 'OG001', 'title': 'Standard Endoscopy', 'description': 'all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': "Our hypothesis was that the yield for neoplasia would be higher using confocal laser endomicroscopy compared to standard endoscopy. The null hypothesis would be that there is no difference in yield for neoplasia when CLE is used compared to standard endoscopy. This analysis looks specifically at patients who were referred for surveillance of Barrett's esophagus (no suspected neoplasia).", 'unitOfMeasure': 'percent yield for neoplasia', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was per protocol as the patients who did not undergo CLE could not be analyzed at all (cannot compare 2 procedures when only one (or zero) are performed).'}, {'type': 'SECONDARY', 'title': "Mean Number of Biopsies With Neoplasia in Barrett's Surveillance Patients", 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Confocal Laser Endomicroscopy', 'description': 'all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.'}, {'id': 'OG001', 'title': 'Standard Endoscopy', 'description': 'all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'analyses': [{'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': "The number of biopsies showing neoplasia was determined for each procedure (confocal laser endomicroscopy, standard EGD). These were compared. This analysis looks at the patients referred for Barrett's surveillance EGD (no suspected neoplasia).", 'statisticalMethod': 'Wilcoxon signed-rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': "The number of biopsies from each procedure (i.e. biopsies taken during CLE, or biopsies taken during standard EGD) that showed neoplasia. Neoplasia is high grade dysplasia or cancer. This analysis looks at patients undergoing surveillance EGD for Barrett's esophagus (no suspected neoplasia).", 'unitOfMeasure': 'number of biopsies with neoplasia', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was per protocol. Each participant was compared to self, so if the participant did not complete the study, no comparison could be made.'}, {'type': 'SECONDARY', 'title': "Mean Number of Biopsies Taken in Barrett's Surveillance Patients", 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Confocal Laser Endomicroscopy', 'description': 'all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.'}, {'id': 'OG001', 'title': 'Standard Endoscopy', 'description': 'all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '12'}, {'value': '12.6', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '28'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The null hypothesis would be that CLE does not decrease the number of biopsies needed to make a diagnosis compared to standard endoscopy', 'statisticalMethod': 'Wilcoxon signed-rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': "The number of biopsies taken during each procedure (i.e. the number of biopsies taken during CLE, or the number of biopsies taken during standard EGD). Biopsies are taken during CLE only if CLE shows that the esophageal mucosa is abnormal. Esophageal biopsies are taken during standard EGD using a standard Barrett's esophagus protocol (4 quadrants, every 1-2 cm of the Barrett's esophagus). This analysis looks at the patients with Barrett's esophagus in the study who were undergoing surveillance EGD (no suspected neoplasia).", 'unitOfMeasure': 'mean number of biopsies', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was per protocol. Each participant was compared to self, so if the participant did not complete, the study, no comparison could be made. The patients in this analysis were referred for surveillance of Barrett's esophagus (no suspected neoplasia)."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CLE Followed by Standard EGD', 'description': 'Patients randomized to either CLE or standard endoscopy first. The other procedure was then performed 6 weeks later. This group was randomized to CLE first, followed by standard endoscopy'}, {'id': 'FG001', 'title': 'Standard EGD Followed by CLE', 'description': 'Patients in this group were randomized to have standard EGD followed by CLE 6 weeks later'}], 'periods': [{'title': 'First Procedure', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'invasive cancer on EGD (excl criteria)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'active wheezing (did not have procedure)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'esophageal stricture found (excl crit)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Procedure', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'active wheezing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Recruited from April 2007 to May 2008 from the gastroenterology clinics at Johns Hopkins University.', 'preAssignmentDetails': 'None of the patients enrolled were excluded prior to group assignment. 1 patient dropped out prior to the first procedure.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Patients received both procedures (CLE and standard EGD), so baseline characteristics are reported for the group'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.8', 'spread': '9.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-17', 'studyFirstSubmitDate': '2007-06-18', 'resultsFirstSubmitDate': '2011-06-21', 'studyFirstSubmitQcDate': '2007-06-18', 'lastUpdatePostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-08-16', 'studyFirstPostDateStruct': {'date': '2007-06-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic Yield for Neoplasia in High Risk Patients(Suspected Neoplasia)', 'timeFrame': '6 weeks', 'description': 'The yield for neoplasia is calculated by the number of biopsies showing neoplasia over the total number of biopsies taken (normal + neoplastic biopsies)'}], 'secondaryOutcomes': [{'measure': 'Mean Number of Biopsies With Neoplasia in High Risk Patients (Suspected Neoplasia)', 'timeFrame': '6 weeks', 'description': "The number of biopsies from each procedure (i.e. biopsies taken during CLE, or biopsies taken during standard EGD) that showed neoplasia. Neoplasia is high grade dysplasia or cancer. This analysis looks at patients with Barrett's suspected (but not known) neoplasia."}, {'measure': 'Mean Number of Biopsies Taken in High Risk Patients (Suspected Neoplasia)', 'timeFrame': '6 weeks', 'description': "The number of biopsies taken during each procedure (i.e. the number of biopsies taken during CLE, or the number of biopsies taken during standard EGD). Biopsies are taken during CLE only if CLE shows that the esophageal mucosa is abnormal. Esophageal biopsies are taken during standard EGD using a standard Barrett's esophagus protocol (4 quadrants, every 1-2 cm of the Barrett's esophagus). This analysis looks at the Barrett's patients with suspected (but not known) neoplasia."}, {'measure': "Diagnostic Yield for Neoplasia in Barrett's Surveillance Patients", 'timeFrame': '6 weeks', 'description': "Our hypothesis was that the yield for neoplasia would be higher using confocal laser endomicroscopy compared to standard endoscopy. The null hypothesis would be that there is no difference in yield for neoplasia when CLE is used compared to standard endoscopy. This analysis looks specifically at patients who were referred for surveillance of Barrett's esophagus (no suspected neoplasia)."}, {'measure': "Mean Number of Biopsies With Neoplasia in Barrett's Surveillance Patients", 'timeFrame': '6 weeks', 'description': "The number of biopsies from each procedure (i.e. biopsies taken during CLE, or biopsies taken during standard EGD) that showed neoplasia. Neoplasia is high grade dysplasia or cancer. This analysis looks at patients undergoing surveillance EGD for Barrett's esophagus (no suspected neoplasia)."}, {'measure': "Mean Number of Biopsies Taken in Barrett's Surveillance Patients", 'timeFrame': '6 weeks', 'description': "The number of biopsies taken during each procedure (i.e. the number of biopsies taken during CLE, or the number of biopsies taken during standard EGD). Biopsies are taken during CLE only if CLE shows that the esophageal mucosa is abnormal. Esophageal biopsies are taken during standard EGD using a standard Barrett's esophagus protocol (4 quadrants, every 1-2 cm of the Barrett's esophagus). This analysis looks at the patients with Barrett's esophagus in the study who were undergoing surveillance EGD (no suspected neoplasia)."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Barrett's esophagus", 'Esophageal adenocarcinoma', 'Endoscopy', 'Confocal laser endomicroscopy'], 'conditions': ["Barrett's Esophagus", 'Esophageal Adenocarcinoma']}, 'referencesModule': {'references': [{'pmid': '19559419', 'type': 'RESULT', 'citation': "Dunbar KB, Okolo P 3rd, Montgomery E, Canto MI. Confocal laser endomicroscopy in Barrett's esophagus and endoscopically inapparent Barrett's neoplasia: a prospective, randomized, double-blind, controlled, crossover trial. Gastrointest Endosc. 2009 Oct;70(4):645-54. doi: 10.1016/j.gie.2009.02.009. Epub 2009 Jun 25."}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine if confocal laser endomicroscopy (CLE) can improve detection of Barrett's esophagus, dysplasia, and early esophageal cancer.", 'detailedDescription': "Barrett's esophagus is a leading cause of esophageal adenocarcinoma. Detection of dysplasia and early cancers in Barrett's esophagus can be challenging, time-consuming and expensive. Small lesions may be difficult to detect with standard endoscopy protocols. Confocal laser endomicroscopy (CLE) is a new type of endoscopy where a small confocal microscope is built into the tip of a standard endoscope. For this study, we are comparing confocal laser endomicroscopy (CLE) with targeted biopsies with standard endoscopy (EGD)and biopsy for Barrett's esophagus to determine if CLE is more effective for detecting dysplasia and cancer.\n\nParticipants with Barrett's esophagus in this study undergo 1) CLE with targeted mucosal biopsies (biopsy only taken if CLE shows abnormal tissue) and 2) standard EGD with biopsies. The order of procedures is randomized (some patients have CLE first while others have standard EGD first)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Barrett's esophagus or suspected Barrett's-associated neoplasia\n* Age \\> 18\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Known advanced malignant disease\n* Allergy to the fluorescent contrast agent fluorescein sodium\n* Coagulopathy or bleeding disorder"}, 'identificationModule': {'nctId': 'NCT00487695', 'acronym': 'CEBE', 'briefTitle': "Confocal Endomicroscopy for Barrett's Esophagus", 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': "Confocal Laser Endomicroscopy for Improved Diagnosis of Barrett's Esophagus and Associated Neoplasia", 'orgStudyIdInfo': {'id': 'NA0002805'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CLE followed by standard EGD', 'description': 'Participants are randomized to have either confocal laser endomicroscopy (CLE) or standard endoscopy (EGD) first. Then 6 weeks later, they have the other procedure. This arm is for patients randomized to CLE followed by standard EGD', 'interventionNames': ['Device: confocal laser endomicroscopy (CLE)', 'Device: standard endoscopy (EGD)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard EGD followed by CLE', 'description': 'Patients are randomized to either have standard endoscopy (EGD)or confocal laser endomicroscopy (CLE) first. The second procedure is then completed 6 weeks later. This arm is for patients who had standard endoscopy first.', 'interventionNames': ['Device: confocal laser endomicroscopy (CLE)', 'Device: standard endoscopy (EGD)']}], 'interventions': [{'name': 'confocal laser endomicroscopy (CLE)', 'type': 'DEVICE', 'otherNames': ['Pentax Confocal Laser Endomicroscope(EC3870KCILK)'], 'description': 'Confocal laser endomicroscopy is done by performing standard endoscopy, then using a microscope on the tip of the endoscope to obtain microscopic images of the mucosa. This is done by gently placing the tip of the endoscope on the lining of the esophagus.', 'armGroupLabels': ['CLE followed by standard EGD', 'standard EGD followed by CLE']}, {'name': 'standard endoscopy (EGD)', 'type': 'DEVICE', 'otherNames': ['Olympus upper endoscope (GIF160)'], 'description': 'Standard upper endoscopy (EGD) is performed using a regular upper endoscope, which is used to look at the lining of the esophagus.', 'armGroupLabels': ['CLE followed by standard EGD', 'standard EGD followed by CLE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Marcia I Canto, MD, MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Gastroenterology, Johns Hopkins University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Society for Gastrointestinal Endoscopy', 'class': 'OTHER'}, {'name': 'Pentax, USA', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}