Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-01-05 @ 5:10 PM
Study NCT ID:
NCT00475592
Status:
WITHDRAWN
Last Update Posted:
2017-07-24
First Post:
2007-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Esophageal Variceal Grading: A Comparative Study of Upper Gastrointestinal (GI) Endoscopy and Capsule Endoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004932', 'term': 'Esophageal and Gastric Varices'}, {'id': 'D006975', 'term': 'Hypertension, Portal'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006470', 'term': 'Hemorrhage'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}], 'ancestors': [{'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'study failed to recruit', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-20', 'studyFirstSubmitDate': '2007-05-16', 'studyFirstSubmitQcDate': '2007-05-16', 'lastUpdatePostDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint of the study will be to develop a grading system for esophageal varices using capsule endoscopy.', 'timeFrame': 'Two years'}], 'secondaryOutcomes': [{'measure': 'Secondary endpoints include sensitivity, specificity, inter- and intraobserver variation of variceal grading using capsule endoscopy; patient acceptance; and a cost comparison (facility + professional fees) of the two screening methods.', 'timeFrame': 'Two years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Esophageal Varices', 'Gastric Varices', 'Capsule Endoscopy', 'Portal Hypertension', 'Cirrhosis', 'Gastrointestinal Hemorrhage'], 'conditions': ['Esophageal and Gastric Varices']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop a grading system for esophageal varices using capsule endoscopy in patients with portal hypertension and cirrhosis.', 'detailedDescription': 'Up to 35% of patients with cirrhosis will develop esophageal varices, which carry with them a 1-year and 3-year bleeding rate of 33% and 41%, respectively. Screening for varices with a video endoscopy is limited by its cost, patient compliance, and the risks of sedating a patient with portal hypertension. Capsule endoscopy is a novel method that may reduce the costs and increase compliance for screening.\n\nThe investigators propose to screen 100 consecutive patients with advanced cirrhosis for esophageal varices. A capsule endoscopy and video endoscopy will be done on the same day. The varices seen on video endoscopy will be graded using a standard grading scale. Both capsule and video endoscopy images will be assessed in a blinded fashion by 4 independent investigators. Finally, the video endoscopic images will be compared to capsule endoscopy to develop a capsule endoscopy grading system that corresponds to video endoscopy.\n\nThe primary endpoint of the study will be to develop a grading system for esophageal varices using capsule endoscopy. Secondary endpoints of the study include sensitivity, specificity, inter- and intraobserver variation of variceal grading using capsule endoscopy; patient acceptance as assessed on a visual analogue scale; and a cost comparison (facility fees + professional fees) of the two screening methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Advanced cirrhosis with portal hypertension based on imaging, clinical suspicion, or liver biopsy\n* Age greater than or equal to 18 years old\n* Able to give consent\n\nExclusion Criteria:\n\n* Current implantable cardioverter-defibrillators or pacemaker in place\n* Suspected intestinal obstruction\n* Esophageal swallowing disorder\n* Esophageal stenosis\n* Age less than 18 years old\n* Pregnancy\n* Known Zenker's diverticulum\n* Patients with previous endoscopic or surgical esophageal treatment"}, 'identificationModule': {'nctId': 'NCT00475592', 'briefTitle': 'Validation of Esophageal Variceal Grading: A Comparative Study of Upper Gastrointestinal (GI) Endoscopy and Capsule Endoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Validation of Esophageal Variceal Grading: A Comparative Study of Upper Gastrointestinal (GI) Endoscopy and Capsule Endoscopy', 'orgStudyIdInfo': {'id': 'VaricealGrading_EsoCapsule'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Capsule Endoscopy', 'interventionNames': ['Device: Esophageal Capsule Endoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Upper Gastrointestinal Endoscopy', 'interventionNames': ['Device: Upper Gastrointestinal Endoscopy']}], 'interventions': [{'name': 'Esophageal Capsule Endoscopy', 'type': 'DEVICE', 'armGroupLabels': ['Capsule Endoscopy']}, {'name': 'Upper Gastrointestinal Endoscopy', 'type': 'DEVICE', 'armGroupLabels': ['Upper Gastrointestinal Endoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Paul J Thuluvath, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ethicon, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}