Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
Study NCT ID:
NCT04780256
Status:
RECRUITING
Last Update Posted:
2025-10-03
First Post:
2021-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endoscopic Resection of Gastrointestinal Neoplasms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D004379', 'term': 'Duodenal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}]}, '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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2021-02-28', 'studyFirstSubmitQcDate': '2021-02-28', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'en bloc resection rate', 'timeFrame': 'one month', 'description': 'the en bloc resection is the ability to remove the neoplasia in a single piece'}, {'measure': 'complete resection rate', 'timeFrame': 'one month', 'description': 'the complete resection is the ability to remove the neoplasia with clear margins (R0)'}, {'measure': 'recurrence rate', 'timeFrame': 'one year', 'description': 'recurrence is the recurrence of the neoplasm at the resection site during follow-up'}], 'secondaryOutcomes': [{'measure': 'adverse events rate', 'timeFrame': 'one month', 'description': 'complication rate, early or late, related to the procedure used for endoscopic resection'}, {'measure': 'costs', 'timeFrame': 'one month', 'description': 'evaluation of the costs incurred to perform the endoscopic resection'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endoscopic mucosal resection (EMR)', 'Endoscopic submucosal dissection (ESD)', 'Endoscopic full thickness resection (EFTR)', 'Colorectal ESD', 'Colorectal EMR'], 'conditions': ['Endoscopic Mucosal Resection', 'Endoscopic Submucosal Dissection', 'Gastric Neoplasm', 'Colonic Neoplasms', 'Esophageal Neoplasms', 'Duodenal Neoplasms']}, 'referencesModule': {'references': [{'pmid': '36542136', 'type': 'DERIVED', 'citation': 'Cecinato P, Lisotti A, Azzolini F, Lucarini M, Bassi F, Fusaroli P, Sassatelli R. Left colonic localization, non-granular morphology, and pit pattern independently predict submucosal fibrosis of naive colorectal neoplasms before endoscopic submucosal dissection. Surg Endosc. 2023 Apr;37(4):3037-3045. doi: 10.1007/s00464-022-09828-0. Epub 2022 Dec 21.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to retrospectively investigate the endoscopic resection procedures of cancerous and precancerous lesions of the upper and lower digestive tract in order to evaluate the efficacy and safety outcomes and to compare different resection techniques. In particular, the resection techniques investigated will be mucosectomy, en bloc and piecemeal, endoscopic submucosal dissection (ESD) and its variants, full-thickness resection. The anatomical districts involved will be the esophagus, stomach, duodenum, colon and rectum.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients\\> 18 years of age who have undergone endoscopic resection of cancerous or pre-cancerous lesions of the digestive tract will be included in the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* all patients who have undergone endoscopic resection of an upper or lower digestive tract tumor\n\nExclusion Criteria:\n\n* age under 18\n* inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT04780256', 'briefTitle': 'Endoscopic Resection of Gastrointestinal Neoplasms', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Azienda USL Reggio Emilia - IRCCS'}, 'officialTitle': 'Retrospective Study of Efficacy and Safety of the Endoscopic Removal of Cancerous and Precancerous Lesions of the Upper and Lower Digestive Tract', 'orgStudyIdInfo': {'id': 'CORE 3'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Endoscopic resection', 'type': 'PROCEDURE', 'description': 'The endoscopic resection is the procedure that allows to remove cancerous or precancerous conditions of digestive tract. Endoscopic resection can be preformed by several techniques:\n\n1. Endoscopic mucosal resection (EMR): it allows to remove mucosal lesions\n2. Endoscopic submucosal dissection: it allows to remove mucosal lesions that involved submucosal layer and large lesions\n3. Full-thickness resection: it allows to remove infiltrating lesions by the resection of a little piece of the entire gastrointestinal wall'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Reggio Emilia', 'state': 'RE', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Matteo Lucarini, MD', 'role': 'CONTACT', 'email': 'matteo.lucarini@ausl.re.it'}], 'facility': 'IRCCS-AUSL Reggio Emilia', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}], 'centralContacts': [{'name': 'Paolo Cecinato, MD', 'role': 'CONTACT', 'email': 'paolo.cecinato@ausl.re.it', 'phone': '+390522296111'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda USL Reggio Emilia - IRCCS', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}