Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-02-01 @ 11:54 PM
Study NCT ID:
NCT02121366
Status:
UNKNOWN
Last Update Posted:
2014-04-23
First Post:
2014-03-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EUS-guided Ethanol Ablation of an Insulinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-11-16', 'releaseDate': '2015-10-19'}, {'releaseDate': '2015-12-14', 'unreleaseDateUnknown': True}, {'resetDate': '2016-01-21', 'releaseDate': '2015-12-16'}, {'resetDate': '2016-09-30', 'releaseDate': '2016-08-09'}, {'resetDate': '2016-12-15', 'releaseDate': '2016-10-25'}], 'estimatedResultsFirstSubmitDate': '2015-10-19'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007340', 'term': 'Insulinoma'}], 'ancestors': [{'id': 'D007516', 'term': 'Adenoma, Islet Cell'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-04-22', 'studyFirstSubmitDate': '2014-03-26', 'studyFirstSubmitQcDate': '2014-04-22', 'lastUpdatePostDateStruct': {'date': '2014-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of EUS-guided ethanol ablation', 'timeFrame': '1 to 12 month', 'description': 'Volumes of insulinomas before and after treatment, which are measured by cross-sectional imaging test (CT or MRS).'}, {'measure': 'Safety of EUS-guided ethanol ablation', 'timeFrame': '1 to 12 month', 'description': 'Number of subjects with post-procedure adverse events'}], 'secondaryOutcomes': [{'measure': 'Technical feasibility', 'timeFrame': 'during the procedure of treatment', 'description': 'Technical success was defined as ethanol is injected and lavaged into target tissue.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Endoscopic Ultrasound-Guided Fine Needle Aspiration', 'Insulinoma', 'Ethanol', 'Ablation Techniques'], 'conditions': ['Insulinoma']}, 'descriptionModule': {'briefSummary': 'The present study aims to evaluate the feasibility, safety and efficacy of EUS-guided ethanol ablation of an insulinoma.', 'detailedDescription': 'As the major insulinomas are functioning islet cell tumors, surgical resection is currently first-line therapy for or treatment of insulinomas. However, the surgical resection of pancreatic neoplasm is conditional for specific patients and may be associated with substantial life-threatening complications. Several studies declared that endoscopic ultrasound (EUS)-guided lavage may offer an alternative to surgical resection of insulinomas. Nevertheless, their sample sizes were small and conclusions were built based on short-term outcomes. In addition, the amount of ethanol administrated for different types of insulinomas were inconsistent among those studies.\n\nThe present study aims to evaluate the safety, feasibility and efficacy of EUS-guided ethanol ablation therapy of insulinomas. We will use cytopathology and immunohistochemistry in combination with EUS-FNA for diagnosis of insulinoma. After EUS-guided ethanol ablation therapy, the safety and efficacy will be assessed at the baseline and different time points during follow-up by physicians blinded to the treatment or control status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults: at least 18 years.\n2. Patients with insulinomas which are evaluated by histopathology .\n3. patients who have signed a written consent form.\n\nExclusion Criteria:\n\n1. Patients whose condition is not suitable for the endoscopic procedure.\n2. Patients who have blood coagulation dysfunction.\n3. Patients who have mental disorders.\n4. Patients who have mild or severe cardiorespiratory insufficiency.\n5. Patients who have hypertension and could not be controlled to safe level.\n6. Pregnant and lactating women.\n7. Patients whose conditions are not suitable for the present study.'}, 'identificationModule': {'nctId': 'NCT02121366', 'acronym': 'EUS', 'briefTitle': 'EUS-guided Ethanol Ablation of an Insulinoma', 'organization': {'class': 'OTHER', 'fullName': 'Guangxi Medical University'}, 'officialTitle': 'Endoscopic Ultrasound (EUS)-Guided Ethanol Ablation of an Insulinoma - A Multi-center Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'EUS0511'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Insulinoma', 'description': 'Patients with Insulinomas will received EUS-guided ethanol ablation therapy', 'interventionNames': ['Procedure: EUS-guided ethanol ablation']}], 'interventions': [{'name': 'EUS-guided ethanol ablation', 'type': 'PROCEDURE', 'description': 'Diagnostic evaluation for suspected insulinoma is performed by cytology or immunohistochemistry. EUS-FNA is performed to obtain samples. After puncturing with the needle, ethanol under the guidance of EUS was injected into the lesion. The amount of ethanol is administrated according to the size of lesion.', 'armGroupLabels': ['Insulinoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '530021', 'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': 'First Affiliated Hospital of Guangxi Medical University', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}], 'overallOfficials': [{'name': 'Shanyu Qin, MD. Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'First Affiliated Hospital of Guangxi Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangxi Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'First Affiliated Hospital of Guangxi Medical University', 'investigatorFullName': 'Shanyu Qin', 'investigatorAffiliation': 'Guangxi Medical University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-10-19', 'type': 'RELEASE'}, {'date': '2015-11-16', 'type': 'RESET'}, {'date': '2015-12-14', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2015-12-16', 'type': 'RELEASE'}, {'date': '2016-01-21', 'type': 'RESET'}, {'date': '2016-08-09', 'type': 'RELEASE'}, {'date': '2016-09-30', 'type': 'RESET'}, {'date': '2016-10-25', 'type': 'RELEASE'}, {'date': '2016-12-15', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Shanyu Qin, First Affiliated Hospital of Guangxi Medical University, Guangxi Medical University'}}}}