Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2026-03-01 @ 12:04 PM
Study NCT ID:
NCT02989818
Status:
RECRUITING
Last Update Posted:
2025-06-24
First Post:
2016-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-center Evaluation of the Clinical Utility of ESD in the Western Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069916', 'term': 'Endoscopic Mucosal Resection'}], 'ancestors': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2016-12-08', 'studyFirstSubmitQcDate': '2016-12-08', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of en-bloc resection', 'timeFrame': '3-4 hours', 'description': 'An Excision of the targeted lesion in a single specimen'}], 'secondaryOutcomes': [{'measure': 'Rate of R0 resection', 'timeFrame': '3-4 hours', 'description': 'when all vertical and horizontal margins are negative'}, {'measure': 'Rate of R1 resection', 'timeFrame': '3-4 hours', 'description': 'complete resection with no grossly visible lesion defined by endoscopist but microscopically positive horizontal and /or vertical margins'}, {'measure': 'Curative resection', 'timeFrame': '3-4 hours', 'description': 'this will have the following: R0 resection, Well to moderately differentiated histology, Absence of Lymphovascular invasion, Absence of budding, Absence of invasion beyond superficial submucosa'}, {'measure': 'Rate of Adverse events with ESD', 'timeFrame': '1 month', 'description': 'Early (\\<48 hours) and late (\\>48 hours) adverse events defined based on previously established criteria by the American Society of Gastrointestinal Endoscopy (ASGE)'}, {'measure': 'Rate of complete remission of neoplasia', 'timeFrame': '1 month', 'description': 'Absence of a visible lesion and/or absence of the neoplastic lesion on biopsy specimens (histopathology) obtained from the ESD site on follow up evaluations'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Endoscopic Submucosal Dissection']}, 'referencesModule': {'references': [{'pmid': '36731578', 'type': 'DERIVED', 'citation': 'King W, Draganov P, Gorrepati VS, Hayat M, Aihara H, Karasik M, Ngamruengphong S, Aadam AA, Othman MO, Sharma N, Grimm IS, Rostom A, Elmunzer BJ, Yang D. Safety and feasibility of same-day discharge after endoscopic submucosal dissection: a Western multicenter prospective cohort study. Gastrointest Endosc. 2023 Jun;97(6):1045-1051. doi: 10.1016/j.gie.2023.01.042. Epub 2023 Jan 30.'}, {'pmid': '34906544', 'type': 'DERIVED', 'citation': "Yang D, King W, Aihara H, Karasik MS, Ngamruengphong S, Aadam AA, Othman MO, Sharma N, Grimm IS, Rostom A, Elmunzer BJ, Jawaid SA, Perbtani YB, Hoffman BJ, Akki AS, Schlachterman A, Coman RM, Wang AY, Draganov PV. Effect of endoscopic submucosal dissection on histologic diagnosis in Barrett's esophagus visible neoplasia. Gastrointest Endosc. 2022 Apr;95(4):626-633. doi: 10.1016/j.gie.2021.11.046. Epub 2021 Dec 11."}, {'pmid': '33610532', 'type': 'DERIVED', 'citation': 'Draganov PV, Aihara H, Karasik MS, Ngamruengphong S, Aadam AA, Othman MO, Sharma N, Grimm IS, Rostom A, Elmunzer BJ, Jawaid SA, Westerveld D, Perbtani YB, Hoffman BJ, Schlachterman A, Siegel A, Coman RM, Wang AY, Yang D. Endoscopic Submucosal Dissection in North America: A Large Prospective Multicenter Study. Gastroenterology. 2021 Jun;160(7):2317-2327.e2. doi: 10.1053/j.gastro.2021.02.036. Epub 2021 Feb 19.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this multi-center study is to prospectively document the clinical utility of ESD.', 'detailedDescription': 'Multi-center prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed.\n\nAll patients scheduled to undergo ESD at the University of Florida and participating centers as medically indicated will be considered for the study. Patients in whom ESD is considered as part of their standard medical care will be offered to participate in this study. The physician performing the procedure will also discuss the study with the subjects. If the patient agrees to participate, he or she will be given the informed consent form and allowed enough time to read it. Opportunity to ask questions will be provided. If the patient agrees to participate, he or she will sign the consent form and a copy will be provided. Data will be prospectively recorded according to the data collection form. ESD will be performed as medically indicated. The investigators from each respective center on this project will also be in charge of the medical care of the patients enrolled in the study. Follow-up will be carried out as medically indicated and no additional studies or clinic visits will be needed specifically for the purpose of this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled to undergo ESD at the University of Florida and participating centers as medically indicated and part of their standard of care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a. Age 18 years or older.\n* b. Scheduled to undergo ESD as part of their standard of care.\n\nExclusion Criteria:\n\n* a. Any contraindication to performing endoscopy.\n* b. Participation in another research protocol that could interfere or influence the outcome measures of the present study.\n* c. Patient is unable/unwilling to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT02989818', 'briefTitle': 'Multi-center Evaluation of the Clinical Utility of ESD in the Western Population', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Multi-center Prospective Evaluation of the Clinical Utility of Endoscopic Submucosal Dissection (ESD) in the Western Population', 'orgStudyIdInfo': {'id': 'IRB201600246'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lesion of the Gastrointestinal tract', 'description': 'Investigator will collect prospective data on the Endoscopic Submucosal dissection that is used as part of the subjects standard of care to remove the Gastrointestinal lesion', 'interventionNames': ['Other: Endoscopic Submucosal Dissection']}], 'interventions': [{'name': 'Endoscopic Submucosal Dissection', 'type': 'OTHER', 'otherNames': ['ESD'], 'description': 'This intervention is part of the subjects standard of care and is a method to remove the Gastrointestinal lesion.', 'armGroupLabels': ['Lesion of the Gastrointestinal tract']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Peter Draganov, MD', 'role': 'CONTACT', 'email': 'peter.draganov@medicine.ufl.edu', 'phone': '352-273-9472'}, {'name': 'Peter Draganov, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Peter Draganov, MD', 'role': 'CONTACT', 'email': 'peter.draganov@medicine.ufl.edu', 'phone': '352-273-9472'}], 'overallOfficials': [{'name': 'Peter Draganov, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}