Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-31 @ 8:49 PM
Study NCT ID:
NCT05566093
Status:
RECRUITING
Last Update Posted:
2022-10-04
First Post:
2022-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EUS-FNI for Nonfunctional Pancreatic Neuroendocrine Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536126', 'term': 'Non functioning pancreatic endocrine tumor'}, {'id': 'D007516', 'term': 'Adenoma, Islet Cell'}], 'ancestors': [{'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': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-30', 'studyFirstSubmitDate': '2022-09-25', 'studyFirstSubmitQcDate': '2022-09-30', 'lastUpdatePostDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of complete ablation', 'timeFrame': 'At 24 months after treatment', 'description': 'The rate of complete ablation on the CE-CT or CE-EUS'}, {'measure': 'The Chang The change of tumor size', 'timeFrame': 'From baseline to 24 months', 'description': 'The change of tumor size on the CE-CT or EUS'}], 'secondaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'Within 3 month after treatment', 'description': 'The incidence of adverse events （such as abdominal pain, hematoma formation, ulcer at the puncture site, acute pancreatitis, pancreatic necrosis, and pancreatic duct stricture）'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nonfunctional Pancreatic Neuroendocrine Tumor', 'Endoscopic ultrasonography-guided fine-needle injection', 'Ablation', 'Endoscopic ultrasonography'], 'conditions': ['Nonfunctional Pancreatic Neuroendocrine Tumor', 'Pancreatic Neuroendocrine Tumor', 'Endoscopic Ultrasound']}, 'descriptionModule': {'briefSummary': 'The current study aims to access the feasibility, safety, and efficacy of EUS-FNI for nonfunctional pNETs', 'detailedDescription': 'The management of nonfunctional pancreatic neuroendocrine tumors (NF-pNETs) remains controversial. In general, surgical resection is the standard treatment for NF-pNETs. However, the incidence of postoperative adverse events of surgical resection is relatively high. Recently, several studies have revealed that endoscopic ultrasonography (EUS)-guided fine-needle injection (EUS-FNI) with ethanol or lauromacrogol may offer an effective treatment for pNETs. Therefore, a multicenter prospective study is being conducted to further identify the efficacy and safety of EUS-FNI for NF-pNETs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with NF-pNETs are evaluated by cytology or immunohistochemistry.\n2. Patients who refuse surgery or observation.\n3. Patients who have given their fully informed consent.\n\nExclusion Criteria:\n\n1. Patients who are not suitable for EUS-FNI.\n2. Patients who have poor conditions including blood coagulation dysfunction, mental disorders, and mild or severe cardiorespiratory.'}, 'identificationModule': {'nctId': 'NCT05566093', 'briefTitle': 'EUS-FNI for Nonfunctional Pancreatic Neuroendocrine Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Guangxi Medical University'}, 'officialTitle': 'Endoscopic Ultrasound-guided Fine-needle Injection for Nonfunctional Pancreatic Neuroendocrine Tumors: a Prospective Multicenter Study', 'orgStudyIdInfo': {'id': '2022-K039-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nonfunctional pancreatic neuroendocrine tumors', 'description': 'The patients with NF-pNETs will undergo EUS-guided ethanol or lauromacrogol ablation', 'interventionNames': ['Procedure: EUS-guided ethanol ablation', 'Procedure: EUS-guided lauromacrogol ablation']}], 'interventions': [{'name': 'EUS-guided ethanol ablation', 'type': 'PROCEDURE', 'description': 'After puncturing with the needle, 95% ethanol under the guidance of EUS was injected into the tumor. The injection volume of ethanol was estimated according to the following principles: (1) The injection volume was not larger than the tumor spherical volume. (2) Injection volume was reduced when the tumor was adjacent to the pancreatic duct or vessel. (3) Injection volume for the lesions with repeated EUS-FNI was reduced.', 'armGroupLabels': ['Nonfunctional pancreatic neuroendocrine tumors']}, {'name': 'EUS-guided lauromacrogol ablation', 'type': 'PROCEDURE', 'description': 'After puncturing with the needle, lauromacrogol under the guidance of EUS was injected into the tumor. The injection volume of lauromacrogol was estimated according to the following principles: (1) The injection volume was not larger than the tumor spherical volume. (2) Injection volume was reduced when the tumor was adjacent to the pancreatic duct or vessel. (3) Injection volume for the lesions with repeated EUS-FNI was reduced.', 'armGroupLabels': ['Nonfunctional pancreatic neuroendocrine tumors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '530021', 'city': 'Nanning', 'state': 'Guangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shanyu Qin, MD,Ph.D', 'role': 'CONTACT', 'email': 'qsy0511@163.com', 'phone': '86-771-5356725'}, {'name': 'Shanyu Qin, MD,Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'First Affiliated Hospital of Guangxi Medical University', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}], 'centralContacts': [{'name': 'Shanyu Qin, MD,Ph.D', 'role': 'CONTACT', 'email': 'qsy0511@163.com', 'phone': '86-771-5353725'}, {'name': 'Haixing Jiang, MD,Ph.D', 'role': 'CONTACT', 'email': 'gxjiaghx@163.com', 'phone': '86-771-5353725'}], 'overallOfficials': [{'name': 'Shanyu Qin, MD,Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Guangxi Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangxi Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Shanyu Qin', 'investigatorAffiliation': 'Guangxi Medical University'}}}}