Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-28 @ 2:26 AM
Study NCT ID:
NCT06790056
Status:
COMPLETED
Last Update Posted:
2025-01-23
First Post:
2024-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Endoscopic Band Ligation (DEBL) for Duodenal Neuroendocrine Neoplasms(dNENs)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-22', 'studyFirstSubmitDate': '2024-01-11', 'studyFirstSubmitQcDate': '2025-01-22', 'lastUpdatePostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Therapeutic efficacy (clinical success) of dEBL at 3 months and 1 year', 'timeFrame': 'One year', 'description': 'Therapeutic efficacy (clinical success) of dEBL at 3 months and 1 year'}], 'secondaryOutcomes': [{'measure': 'Adverse events and recurrence on follow up', 'timeFrame': 'One year', 'description': 'Univariate and multivariate analysis will be done to determine which are the factors associated with clinical success and clinical recurrence'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lesion size,', 'tumour', 'binding'], 'conditions': ['Duodenal Neuroendocrine Tumor']}, 'descriptionModule': {'briefSummary': 'Primary objective To evaluate the therapeutic efficacy (clinical success) of dEBL at 3 months\n\n2b. Secondary objective\n\nTo evaluate adverse events, technical success and recurrence on follow-up\n\n50 patients over 1-year duration based on our previous study of Prospective data (2023-2024)', 'detailedDescription': 'We will collect your basic demographics details like age, Sex, date of admission, Endoscopy (is a test to look inside your body) details of Site, size, number of lesion.\n\nBy EUS (Endoscopic ultrasound (EUS) combines two techniques - endoscopy and ultrasound - to help doctors see, evaluate and diagnose conditions in and near the gastrointestinal (GI) tract) details of layer of Duodenum involved, site/size/number of lesions.\n\nWe will collect your details of Duodenal endoscopic band ligation procedure to check feasibility, technical success.\n\nYou are requested to come for follow up for 3 months for endoscopy prodecure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '50 patients over 1-year duration .', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients age \\>18 years\n* Size of lesion less than 15mm\n* Site of lesion- duodenum (d1-d4)\n* No of lesions- ≤6\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Non-duodenal lesion\n* Local or distant metastasis\n* Lumen occluding lesions\n* Uncorrectable coagulopathy\n* Not willing for consent'}, 'identificationModule': {'nctId': 'NCT06790056', 'acronym': 'DEBL', 'briefTitle': 'Efficacy of Endoscopic Band Ligation (DEBL) for Duodenal Neuroendocrine Neoplasms(dNENs)', 'organization': {'class': 'OTHER', 'fullName': 'Asian Institute of Gastroenterology, India'}, 'officialTitle': 'Efficacy of Endoscopic Band Ligation (DEBL) for Duodenal Neuroendocrine Neoplasms(dNENs) : A Prospective Study', 'orgStudyIdInfo': {'id': 'DEBL- 01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Duodenal endoscopic band ligation group', 'description': 'We will collect your basic demographics details like age, Sex, date of admission, Endoscopy (is a test to look inside your body) details of Site, size, number of lesion.\n\nBy EUS (Endoscopic ultrasound (EUS) combines two techniques - endoscopy and ultrasound - to help doctors see, evaluate and diagnose conditions in and near the gastrointestinal (GI) tract) details of layer of Duodenum involved, site/size/number of lesions.\n\nWe will collect your details of Duodenal endoscopic band ligation procedure to check feasibility, technical success.\n\nYou are requested to come for follow up for 3 months for endoscopy prodecure.', 'interventionNames': ['Procedure: duodenal ndoscopic bind ligation']}], 'interventions': [{'name': 'duodenal ndoscopic bind ligation', 'type': 'PROCEDURE', 'description': 'We will collect your basic demographics details like age, Sex, date of admission, Endoscopy (is a test to look inside your body) details of Site, size, number of lesion.\n\nBy EUS (Endoscopic ultrasound (EUS) combines two techniques - endoscopy and ultrasound - to help doctors see, evaluate and diagnose conditions in and near the gastrointestinal (GI) tract) details of layer of Duodenum involved, site/size/number of lesions.\n\nWe will collect your details of Duodenal endoscopic band ligation procedure to check feasibility, technical success.\n\nYou are requested to come for follow up for 3 months for endoscopy prodecure.', 'armGroupLabels': ['Duodenal endoscopic band ligation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '500082', 'city': 'Hyderabad', 'state': 'Telangana', 'country': 'India', 'facility': 'Hardik Rughwani', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}], 'overallOfficials': [{'name': 'Hardik Rughwani', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AIG HOSPITALS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asian Institute of Gastroenterology, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Gastroenterologist', 'investigatorFullName': 'Mohan Ramchandani', 'investigatorAffiliation': 'Asian Institute of Gastroenterology, India'}}}}