Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT03444051
Status:
COMPLETED
Last Update Posted:
2018-02-23
First Post:
2018-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Two Endoscopic Biopsic Needles for Pancreatic Tumors
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-18', 'studyFirstSubmitDate': '2018-02-18', 'studyFirstSubmitQcDate': '2018-02-18', 'lastUpdatePostDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pancreatic mass anatomopathological characterization', 'timeFrame': 'in the 7 days after procedure', 'description': 'pancreatic mass anatomopathological characterization, presence of histological sampling and cumulative length of tissue core biopsies per needle pass.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EUS-FNB', 'comparative study'], 'conditions': ['Pancreatic Tumor', 'Puncture']}, 'descriptionModule': {'briefSummary': 'This observational study compared quality of histological sampling of pancreatic EUS-FNB with the 20-gauge Procore® and 22-gauge Acquire® needles. In total, 68 patients were recruited. Histological diagnosis was achieved and a histological core biopsy was obtained in 82% of patients (28/34) in the 20-gauge Procore® group and 97% of patients (33/34) in the 22-gauge Acquire® group (P=0.1). Core biopsy specimens obtained were significantly longer with the 22-gauge Acquire® needle with a mean cumulative length of tissue core biopsies per needle pass of 4,33±3,46mm vs. 7,9±4,35mm for the 20-gauge Procore® (P\\<0,01). Reproducibility of this simple histological criterion was validated in intra and inter-observer.', 'detailedDescription': 'Between March and December 2017, 68 EUS-FNB were consecutively performed in our unit for a pancreatic or peripancreatic mass. The choice of the needle depended upon the availability at the time of admission: 34 punctures were performed with a 20-gauge Procore®, and 34 with a 22-gauge Acquire®. Histological material was studied in a blinded manner with respect to the needle, and cumulative length of tissue core biopsies per needle pass was determined. Intra and inter-observer variability of this criterion was then evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive patients ≥18 who were referred for EUS-FNB for solid pancreatic or peripancreatic mass were included. The use of EUS-FNB needle was determined during EUS if the examination confirmed the presence of a pancreatic or peri-pancreatic non-hyper-vascular mass (on Doppler examination).\n\nAccording to the period of admission, the 20-gauge Procore® (Wilson Cook Medical, Winston-Salem, NC) and 22-gauge Acquire® needles (Boston Scientific Natick, MA) were alternatively available depending on the order (made in batches of 5 units). So, patients were included either in the 20-gauge Procore® group or the 22-gauge Acquire® group.\n\nPatients could be switched via a crossover procedure to a second EUS-FNB with the competitive needle if the first one failed to give histologic mass characterization: failure was recorded to the first needle group, and the second EUS-FNB performed with the alternate needle was recorded in the other group.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All consecutive patients ≥18 who were referred for EUS-FNB for solid pancreatic or peripancreatic mass were included\n\nExclusion Criteria:\n\n* non-accessible pancreatic mass because of history of Billroth II or Roux-en-Y reconstruction\n* coagulation disorders (such as partial thromboplastin time \\>42 seconds, prothrombin time \\[Quick value\\] \\<50%, platelet count \\<50 000/mm³), treatment with clopidogrel, pregnancy.\n* patients \\<18 years of age'}, 'identificationModule': {'nctId': 'NCT03444051', 'acronym': 'Mousquetaires', 'briefTitle': 'Comparison of Two Endoscopic Biopsic Needles for Pancreatic Tumors', 'organization': {'class': 'OTHER', 'fullName': "Société Française d'Endoscopie Digestive"}, 'officialTitle': 'Comparison of the 20-gauge Procore® and 22-gauge Acquire® Needles for Endoscopic Ultrasound-guided Fine Needle Biopsy (EUS-FNB) of Solid Pancreatic or Peripancreatic Masses: an Observational Study.', 'orgStudyIdInfo': {'id': 'Mousquetaires'}}, 'armsInterventionsModule': {'armGroups': [{'label': '20-gauge Procore®', 'description': 'Between March and December 2017, 68 EUS-FNB were consecutively performed in our unit for a pancreatic or peripancreatic mass. The choice of the needle depended upon the availability at the time of admission:\n\n34 punctures were performed with a 20-gauge Procore® during the period study', 'interventionNames': ['Procedure: EUS-FNB with 20-gauge Procore® needle']}, {'label': '22-gauge Acquire®', 'description': 'Between March and December 2017, 68 EUS-FNB were consecutively performed in our unit for a pancreatic or peripancreatic mass. The choice of the needle depended upon the availability at the time of admission:\n\n34 punctures were performed with a 22-gauge Acquire® during the period study', 'interventionNames': ['Procedure: EUS-FNB with 22-gauge Acquire® needle']}], 'interventions': [{'name': 'EUS-FNB with 20-gauge Procore® needle', 'type': 'PROCEDURE', 'description': 'Puncture of a pancreatic or peripancreatic mass under Endoscopic Ultrasonography, with a 20-gauge Procore® needle', 'armGroupLabels': ['20-gauge Procore®']}, {'name': 'EUS-FNB with 22-gauge Acquire® needle', 'type': 'PROCEDURE', 'description': 'Puncture of a pancreatic or peripancreatic mass under Endoscopic Ultrasonography, with a 22-gauge Acquire®', 'armGroupLabels': ['22-gauge Acquire®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94220', 'city': 'Charenton-le-Pont', 'country': 'France', 'facility': 'Clinique PARIS-BERCY', 'geoPoint': {'lat': 48.82209, 'lon': 2.41217}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Société Française d'Endoscopie Digestive", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'KARSENTI', 'investigatorAffiliation': "Société Française d'Endoscopie Digestive"}}}}