Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT05930860
Status:
RECRUITING
Last Update Posted:
2025-03-14
First Post:
2023-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of ESD for the Treatment of Superficial Gastric Neoplasms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach 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'}]}, '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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2031-12-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2023-03-02', 'studyFirstSubmitQcDate': '2023-07-03', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'En bloc resection rate', 'timeFrame': '10 years', 'description': 'removal of the lesion into a single piece.'}, {'measure': 'R0 resection rate', 'timeFrame': '10 years', 'description': 'complete removal of the tumor with histologically lateral and vertical margins of the specimen free from dysplasia'}, {'measure': 'Curative resection rate', 'timeFrame': '10 years', 'description': 'R0 resection with combined microstaging parameters not suggestive for high metastatic potential risk.'}, {'measure': 'Complication rate', 'timeFrame': '10 years', 'description': 'bleeding, perforation and stenosis.'}, {'measure': 'Recurrence rate', 'timeFrame': '10 years', 'description': 'dysplastic tissue at the site of resection at follow-up endoscopy.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endoscopic Submucosal Dissection', 'Endoscopic Resection'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'Endoscopic submucosal dissection (ESD) is the technique that has replaced surgery in the treatment of early neoplastic lesions of the stomach (LNPS). ESD of LNPS allows: a) less invasiveness compared to surgery; b) greater chances of "en bloc" resection and R0 resection compared to mucosectomy for lesions larger than 15 mm. Recent 2015 ESGE guidelines provide precise recommendations for the use of ESD in the treatment of LNPS, but Italy lacks prospective data on the efficacy and safety of ESD in a large sample of patients. A multicenter prospective observational study to create a database on the use of ESD in LNPS is essential to provide information regarding the efficacy and safety of ESD in Italy. This database would also provide information regarding the criteria applied in the use of ESD in the treatment of early gastric neoplasia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with gastric superficial neoplasms that can be treated by ESD according to ESGE guidelines or with gastric neoplasm outside of latest ESD guidelines criteria that are unfit for surgery.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years old\n* Endoscopic and histologic diagnosis of gastric superficial neoplasm that can be treated by ESD according to ESGE guidelines.\n* Gastric neoplasm outside of latest ESD guidelines criteria in patients unfit for surgery\n\nExclusion Criteria:\n\n* Final diagnosis of non neoplastic lesion.\n* Gastric neoplasm outside of latest ESD guidelines criteria in patients fit for surgery\n* Evidence of muscolar layer invasion or limph nodes or other organs metastasis at EUS or TC when performed.'}, 'identificationModule': {'nctId': 'NCT05930860', 'briefTitle': 'Efficacy and Safety of ESD for the Treatment of Superficial Gastric Neoplasms', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Efficacy and Safety of Endoscopic Submucosal Dissection for the Treatment of Superficial Gastric Neoplasms - An Italian Society of Digestive Endoscopy (SIED) Study', 'orgStudyIdInfo': {'id': '4349'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Endoscopic Submucosal Dissection', 'type': 'PROCEDURE', 'description': 'Endoscopic Submucosal Dissection'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Federico Barbaro', 'role': 'CONTACT', 'email': 'federico.barbaro@policlinicogemelli.it', 'phone': '3921101013'}], 'overallOfficials': [{'name': 'Federico Barbaro', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario A. Gemelli, IRCCS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}