Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-02-21 @ 10:02 AM
Study NCT ID:
NCT03021135
Status:
COMPLETED
Last Update Posted:
2023-07-05
First Post:
2016-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conventional Endoscopic Mucosal Resection vs Underwater Resection for Colorectal Non-pedunculated Colorectal Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-30', 'studyFirstSubmitDate': '2016-11-04', 'studyFirstSubmitQcDate': '2017-01-12', 'lastUpdatePostDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical success rate', 'timeFrame': 'three years'}, {'measure': 'Safety (incidence of complications);', 'timeFrame': 'three years'}, {'measure': 'Local recurrence.', 'timeFrame': 'Four years'}], 'secondaryOutcomes': [{'measure': 'Resection rate en bloc', 'timeFrame': 'three years'}, {'measure': 'Time of resection', 'timeFrame': 'Three years'}, {'measure': 'Sydney resection ratio (characterized by the following equation - lesion size in millimeters', 'timeFrame': 'Three years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adenoma', 'Colorectal Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://doi.org/10.1016/j.gie.2022.10.033', 'label': 'Results'}]}, 'descriptionModule': {'briefSummary': 'Randomized, comparative and prospective study between Conventional Endoscopic Mucosal Resection for the removal of flat or sessile colorectal lesions without previous attempt to resection.', 'detailedDescription': 'This prospective randomized trial was conducted in 2 academic services: Instituto do Câncer do Estado de São Paulo and Centro de Diagnóstico em Gastroenterologia, both linked to the University of São Paulo. The clinical study was performed in accordance to the Declaration of Helsinki.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients age \\>18 years with sessile or flat Colorectal Lesions (measuring between 10 and 40mm), who consent to this study\n\nExclusion Criteria:\n\n* Patients who refuse to participate in the study.\n* Patients with pedunculated, depressed or mixed lesions.\n* Patients with lesions smaller than 10 mm or larger than 40 mm.\n* Patients with lesions that are inflammatory, neuroendocrine or stromal at the pathology.\n* Patients with lesions that were submitted to prior attempt to endoscopic resection.'}, 'identificationModule': {'nctId': 'NCT03021135', 'briefTitle': 'Conventional Endoscopic Mucosal Resection vs Underwater Resection for Colorectal Non-pedunculated Colorectal Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Instituto do Cancer do Estado de São Paulo'}, 'officialTitle': 'Conventional Endoscopic Mucosal Resection (With Submucosal Injection) Versus Underwater Endoscopic Mucosal Resection (Without Submucosal Injection) for Colorectal Non-pedunculated Colorectal Lesions', 'orgStudyIdInfo': {'id': 'NP 941/16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Mucosal Resection', 'description': 'C-EMR will be made with saline injection with the indigo carmine.', 'interventionNames': ['Procedure: Conventional Endoscopic Mucosal Resection']}, {'type': 'EXPERIMENTAL', 'label': 'Underwater Mucosal Resection', 'description': 'UW-EMR will be made after the complete filling of lumen with water.', 'interventionNames': ['Procedure: Underwater Endoscopic Mucosal Resection']}], 'interventions': [{'name': 'Conventional Endoscopic Mucosal Resection', 'type': 'PROCEDURE', 'otherNames': ['EMR'], 'description': 'Conventional Endoscopic Mucosal Resection', 'armGroupLabels': ['Conventional Mucosal Resection']}, {'name': 'Underwater Endoscopic Mucosal Resection', 'type': 'PROCEDURE', 'otherNames': ['U-EMR'], 'description': 'Underwater Endoscopic Mucosal Resection', 'armGroupLabels': ['Underwater Mucosal Resection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01246-000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto do Cancer do Estado de Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Luciano Lenz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Institute of the state of São Paulo (ICESP)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto do Cancer do Estado de São Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Sao Paulo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}