Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 10:47 AM
Study NCT ID:
NCT07424456
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Triphasic CT Abdomen and EUS-FNB in Characterization of Pancreatic Lesion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010147', 'term': 'Pain Measurement'}], 'ancestors': [{'id': 'D009460', 'term': 'Neurologic Examination'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-13', 'studyFirstSubmitDate': '2026-02-01', 'studyFirstSubmitQcDate': '2026-02-13', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy of triphasic CT compared to EUS-guided biopsy in differentiating benign from malignant pancreatic lesions.', 'timeFrame': 'one year', 'description': 'the diagnostic accuracy of triphasic CT compared to EUS-guided biopsy in differentiating benign and malignant pancreatic lesions, calculated in terms of sensitivity, specificity, PPV, NPV, and overall accuracy, using final histopathological diagnosis as the reference standard.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Triphasic Ct abdomen vs EUS-FNB', 'EUS-FNB'], 'conditions': ['EUS Guided Biopsy', 'CT Scan', 'Pancreatic Lesions Located at the Body or the Tail']}, 'referencesModule': {'references': [{'pmid': '19803666', 'type': 'BACKGROUND', 'citation': 'Iglesias Garcia J, Larino Noia J, Dominguez Munoz JE. Endoscopic ultrasound in the diagnosis and staging of pancreatic cancer. Rev Esp Enferm Dig. 2009 Sep;101(9):631-8. doi: 10.4321/s1130-01082009000900006.'}, {'type': 'BACKGROUND', 'citation': 'Öztürk B, Ekmen N, et al. The diagnostic role of endoscopic ultrasonography, CT, and MRI in pancreatic cystic lesions. J Clin Med Kaz. 2021;18(4):71-80.'}, {'type': 'BACKGROUND', 'citation': 'Chen J, Sahai AV, et al. Diagnostic accuracy of endoscopic ultrasound-guided fine-needle aspiration in pancreatic tumors. BMC Gastroenterol. 2012;12:125.'}, {'pmid': '38201387', 'type': 'RESULT', 'citation': 'Chatterjee A, Shah J. Role of Endoscopic Ultrasound in Diagnosis of Pancreatic Ductal Adenocarcinoma. Diagnostics (Basel). 2023 Dec 28;14(1):78. doi: 10.3390/diagnostics14010078.'}]}, 'descriptionModule': {'briefSummary': 'evaluate the relationship between triphasic CT and EUS findings and the characterization of pancreatic lesions.', 'detailedDescription': 'Comparison Between Triphasic CT and EUS-FNB in characterization of Pancreatic Lesions'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients (age\\>18 years) presenting with focal pancreatic lesions detected on initial imaging.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\*Adult patients (age\\>18 years) presenting with focal pancreatic lesions detected on initial imaging.\n\n * Patients referred for further evaluation by triphasic CT and/or EUS-guided biopsy.\n * Patients able to provide informed consent\n\nExclusion Criteria:\n\n* Previous pancreatic surgery.\n\n * Known metastatic disease at presentation.\n * Contraindications to contrast-enhanced CT (e.g. severe renal impairment, contrast allergy)\n * Contraindications to EUS or biopsy (e.g., coagulopathy uncorrected, severe cardiopulmonary instability).\n * Pregnancy.'}, 'identificationModule': {'nctId': 'NCT07424456', 'briefTitle': 'Comparison Between Triphasic CT Abdomen and EUS-FNB in Characterization of Pancreatic Lesion', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparison Between Triphasic CT Abdomen and EUS-FNB in Characterization of Pancreatic Lesion', 'orgStudyIdInfo': {'id': 'Triphasic CT vs EUS-FNB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients assessed by Triphasic CT scan', 'description': 'Triphasic CT scan:\n\nPerformed using a multidetector CT scanner and CT parameters assessed:\n\nSize, shape, and margins of the lesion Enhancement pattern (hypo / iso / hyper-enhancing) Calcifications or cystic components', 'interventionNames': ['Diagnostic Test: Full clinical history (pain, jaundice, weight loss, pancreatitis history). Physical examination with focus on abdominal and systemic findings.']}, {'label': 'Patients assessed by Endoscopic Ultrasound (EUS)&Tissue Sampling', 'description': 'Performed using linear echoendoscope under conscious sedation or general anesthesia EUS-guided sampling Fine-needle aspiration (FNA) or fine-needle biopsy (FNB) using 19G/22G needles.\n\nMultiple passes obtained for cytology and histopathology.', 'interventionNames': ['Diagnostic Test: Full clinical history (pain, jaundice, weight loss, pancreatitis history). Physical examination with focus on abdominal and systemic findings.']}], 'interventions': [{'name': 'Full clinical history (pain, jaundice, weight loss, pancreatitis history). Physical examination with focus on abdominal and systemic findings.', 'type': 'DIAGNOSTIC_TEST', 'description': 'Full clinical history (pain, jaundice, weight loss, pancreatitis history). Physical examination with focus on abdominal and systemic findings.', 'armGroupLabels': ['Patients assessed by Endoscopic Ultrasound (EUS)&Tissue Sampling', 'Patients assessed by Triphasic CT scan']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ahmed Abdullah Ashmawy, Prof. Dr', 'role': 'CONTACT', 'email': 'rasharma@aun.edu.eg', 'phone': '01005679880'}, {'name': 'Mohamed Mahdy, ProfDr', 'role': 'CONTACT', 'email': 'drmohhakim@aun.edu.eg', 'phoneExt': '01064455652'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Shaza Mamdouh sayed Abd el-galil', 'investigatorAffiliation': 'Assiut University'}}}}