Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-03-01 @ 10:48 PM
Study NCT ID:
NCT01876069
Status:
COMPLETED
Last Update Posted:
2016-04-27
First Post:
2013-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Newly Developed PreCore Needle With Conventional Fine Needle in Suspected Unresectable Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-25', 'studyFirstSubmitDate': '2013-06-04', 'studyFirstSubmitQcDate': '2013-06-08', 'lastUpdatePostDateStruct': {'date': '2016-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Procedure related complications', 'timeFrame': 'Up to 1 year', 'description': 'Investigate the occurrence of complications such as bleeding, perforation, pancreatitis, infection. Not only complications, but the size and location of lesion, puncture routes will be assessed.'}], 'primaryOutcomes': [{'measure': 'The rates of diagnostic sufficiency', 'timeFrame': 'Up to 1 year', 'description': 'The rates of diagnostic sufficency will be assessed by the pathologist as the proportion of definate diagnosis from cytology and histology within 2 passes of each procendure'}], 'secondaryOutcomes': [{'measure': 'The presence of histologic core', 'timeFrame': 'Up to 1 year', 'description': 'The presence histologic core means the gain of tissue, not clustered cells, through each procedure. It will be also assessed by the pathologist.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'Background:\n\nPancreatic cancer is associated with a poor prognosis. Therefore, rapid and accurate diagnosis of a pancreatic mass is important to direct patient management. Endoscopic ultrasonography-guided fine needle aspiration (EUS-FNA) is the current standard for sampling pancreatic mass lesions, with diagnostic accuracy of 78% to 95%. But, the EUS-FNA has some limitations include stromal cell tumors and lymphomas may be difficult to diagnose. To overcome these limitations, a new needle device with ProCore reverse-bevel technology was developed recently.\n\nAims:\n\nThe objective of this prospective study is to compare the rate of diagnostic sufficiency in the EUS sampling by using newly developed ProCore needle with conventional FNA needle in suspected unresectable pancreatic cancer. We will also compare the safety, the yield of histologic core tissue and the cost-effectiveness between these modalities.', 'detailedDescription': 'Patient:\n\nNewly diagnosed pancreatic cancer patient whose cancer lesion is suspected unresectable in diagnostic imaging such as CT or MRI\n\nProcedure:\n\nEach EUS-guided FNA and ProCore aspiration will performed twice in same patient. The priority of order will be given by randomization assignment.\n\nThe number of patients required:\n\nTotal sixty five patients will be required.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who agree to participate in research\n* 18 years of age and older patients less than 80 years old\n* Patients who have suspected unresectable pancreatic cancer in imaging studies\n\nExclusion Criteria:\n\n* Contraindication to endoscopy\n* Patients younger than 18 years old or older than 80 years old\n* Bleeding tendency\n* Cardiopulmonary dysfunction\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01876069', 'briefTitle': 'Comparing Newly Developed PreCore Needle With Conventional Fine Needle in Suspected Unresectable Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Comparing Newly Developed PreCore Needle With Conventional Fine Needle in Endoscopic Ultrasonography-guided Sampling of Suspected Unresectable Pancreatic Cancer', 'orgStudyIdInfo': {'id': '2013-02-018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '22 gauge ProCore needle aspiration', 'description': 'EUS-guided pancreatic mass aspiration with 22 gauge ProCore needle', 'interventionNames': ['Device: 22 gauge ProCore needle aspiration']}, {'type': 'ACTIVE_COMPARATOR', 'label': '22 gauge Fine needle aspiration', 'description': 'EUS-guided pancreatic mass aspiration with 22 gauge Fine needle', 'interventionNames': ['Device: 22 gauge Fine needle aspiration']}], 'interventions': [{'name': '22 gauge ProCore needle aspiration', 'type': 'DEVICE', 'otherNames': ['EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle'], 'description': 'Pancreatic mass evaluation through the 22 gauge ProCore needle aspiration', 'armGroupLabels': ['22 gauge ProCore needle aspiration']}, {'name': '22 gauge Fine needle aspiration', 'type': 'DEVICE', 'otherNames': ['22 gauge, EN-SHOT2 Side Port Aspiration Needle'], 'description': 'Pancreatic mass evaluation through the 22 gauge Fine needle aspiration', 'armGroupLabels': ['22 gauge Fine needle aspiration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kwang Hyuck Lee, MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Olympus', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Kwang Hyuck Lee', 'investigatorAffiliation': 'Samsung Medical Center'}}}}