Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-28 @ 4:22 PM
Study NCT ID:
NCT04647266
Status:
COMPLETED
Last Update Posted:
2020-11-30
First Post:
2020-11-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pronostic Score of Morbidity to Determine Risk of Complications After Endoscopic Submucosal Dissection for Colorectal Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}], 'ancestors': [{'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'ACTUAL', 'count': 168}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-27', 'studyFirstSubmitDate': '2020-11-23', 'studyFirstSubmitQcDate': '2020-11-27', 'lastUpdatePostDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "To develop clinical or mixed prognostic score after endoscopic subcostal dissection for colorectal lesions in Nancy's hospital.", 'timeFrame': 'From 2016 to 2020'}], 'secondaryOutcomes': [{'measure': 'Allow to obtain an estimation of number of patients required for a larger study', 'timeFrame': 'From 2016 to 2020'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endoscopic Submucosal Dissection'], 'conditions': ['Polyp of Colon']}, 'descriptionModule': {'briefSummary': "The mains complications in colo-rectal dissection are the pain, the delayed bleeding and the perforation and represent around 10%.\n\nCurrently, the procedure is realized during a hospitalization with not real recommendation about the time of this.\n\nThere is currently no score established for the colo-rectal endoscopic submucosal dissection.\n\n* To develop clinical or mixed prognostic score after endoscopic subcostal dissection for colorectal lesions in Nancy's hospital.\n* Allow to obtain an estimation of number of patients required for a larger study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient, more than 18 years old with no contra indication of the general anesthesia suffering of lesion relevant of endoscopic submucosal dissection treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient suffering of lesion relevant of endoscopic submucosal dissection treatment:\n* Lesions for which en bloc resection with snare EMR is difficult to apply i/LST-NG, particularly LST-NG (PD) ii/ Lesions showing a VI-type pit pattern iii/ Carcinoma with shallow T1 (SM) invasion Large depressed-type tumors iv/ Large protruded-type lesions suspected to be carcinoma\n* Mucosal tumors with submucosal fibrosis\n* Sporadic tumors in conditions of chronic inflammation such as ulcerative colitis\n* Local residual or recurrent early carcinomas after endoscopic resection Local res Les lésions de plus\n* Male or female patients aged ≥ 18 years old\n* Patients able to fill in questionnaires written in French\n\nExclusion Criteria:\n\n* Suspicion of deep submucosal cancer by analysis of macroscopic appearance (Paris O-III), vascular pattern and pit pattern (SANO IIIB, KUDO Vn)'}, 'identificationModule': {'nctId': 'NCT04647266', 'briefTitle': 'Pronostic Score of Morbidity to Determine Risk of Complications After Endoscopic Submucosal Dissection for Colorectal Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': "Proof of Concept for the Development of Clinical or Mixed Prognostic Score of Morbidity After Endoscopic Subcostal Dissection for Colorectal Lesions in Nancy's Hospital Since 2016 to Nowadays", 'orgStudyIdInfo': {'id': '2019PI285'}}, 'armsInterventionsModule': {'interventions': [{'name': 'endoscopic submucosal dissection', 'type': 'PROCEDURE', 'description': 'endoscopic submucosal dissection'}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'state': 'Meurthe ET Moselle', 'country': 'France', 'facility': 'CHRU Brabois', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'overallOfficials': [{'name': 'Jean Baptiste CHEVAUX', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Doctor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}