Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-04-10 @ 1:23 PM
Study NCT ID:
NCT02855151
Status:
UNKNOWN
Last Update Posted:
2020-06-17
First Post:
2016-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EUS for Gastrointestinal Disorders: a Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'targetDuration': '2 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-15', 'studyFirstSubmitDate': '2016-07-18', 'studyFirstSubmitQcDate': '2016-08-01', 'lastUpdatePostDateStruct': {'date': '2020-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events', 'timeFrame': '2 days', 'description': 'Documentation of adverse events.'}], 'secondaryOutcomes': [{'measure': 'Diagnostic yied of elastography during EUS', 'timeFrame': '0 Day', 'description': 'sensitivity and specificity of EUS with elastography'}, {'measure': 'Diagnostic yied of Contrast-Enhanced Endoscopic Ultrasonography', 'timeFrame': '0 Day', 'description': 'sensitivity and specificity contrast medium'}, {'measure': 'Tissue acquisition during EUS', 'timeFrame': '0 Days', 'description': 'sensitivity and specificity of tissue acquisition'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EUS'], 'conditions': ['GI Tract Disorders', 'Pancreatic Disorders', 'EUS']}, 'referencesModule': {'references': [{'pmid': '36990125', 'type': 'DERIVED', 'citation': 'Carrara S, Rahal D, Khalaf K, Rizkala T, Koleth G, Bonifacio C, Andreozzi M, Mangiavillano B, Auriemma F, Bossi P, Balzarotti M, Facciorusso A, Staiano T, Maldi E, Spadaccini M, Colombo M, Fugazza A, Maselli R, Hassan C, Repici A. Diagnostic accuracy and safety of EUS-guided end-cutting fine-needle biopsy needles for tissue sampling of abdominal and mediastinal lymphadenopathies: a prospective multicenter series. Gastrointest Endosc. 2023 Aug;98(2):191-198. doi: 10.1016/j.gie.2023.03.018. Epub 2023 Mar 27.'}, {'pmid': '29329992', 'type': 'DERIVED', 'citation': 'Carrara S, Di Leo M, Grizzi F, Correale L, Rahal D, Anderloni A, Auriemma F, Fugazza A, Preatoni P, Maselli R, Hassan C, Finati E, Mangiavillano B, Repici A. EUS elastography (strain ratio) and fractal-based quantitative analysis for the diagnosis of solid pancreatic lesions. Gastrointest Endosc. 2018 Jun;87(6):1464-1473. doi: 10.1016/j.gie.2017.12.031. Epub 2018 Jan 9.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the EUS registry is to record information about Endoscopic Ultrasound (EUS) on the management of gastrointestinal disease. The registry will evaluate efficacy, safety and technical success of the Endoscopic Ultrasound (EUS). Design is retrospective and prospective registry study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients submitted to diagnostic or therapeutic EUS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients submitted to EUS,\n* Informed consent.\n\nExclusion Criteria:\n\n* Age less than 18 y\n* Patient who did not give the consent to the processing of personal data.'}, 'identificationModule': {'nctId': 'NCT02855151', 'briefTitle': 'EUS for Gastrointestinal Disorders: a Registry', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Clinico Humanitas'}, 'officialTitle': 'EUS for Gastrointestinal Disorders: a Registry', 'orgStudyIdInfo': {'id': '1497'}}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Rozzano', 'state': 'Milano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandro Repici, MD', 'role': 'CONTACT', 'email': 'alessandro.repici@humanitas.it', 'phone': '+39282247493'}, {'name': 'Alessandro Repici, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Silvia Carrara, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Andrea Anderloni, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Milena Di Leo, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Endoscopy Unit, Humanitas Research Hospital', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}], 'centralContacts': [{'name': 'Silvia Carrara, MD', 'role': 'CONTACT', 'email': 'silvia.carrara@humanitas.it', 'phone': '+390282247288'}], 'overallOfficials': [{'name': 'Alessandro Repici, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Humanitas University'}, {'name': 'Silvia Carrara, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Humanitas Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Clinico Humanitas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}