Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 11:57 PM
Study NCT ID:
NCT04834193
Status:
COMPLETED
Last Update Posted:
2023-02-02
First Post:
2021-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wet-suction Versus Slow-pull for EUS-FNB of Solid Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-18', 'size': 413220, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-04-05T02:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-01', 'studyFirstSubmitDate': '2021-03-29', 'studyFirstSubmitQcDate': '2021-04-05', 'lastUpdatePostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Histologic yield', 'timeFrame': '6 months', 'description': 'The rate of samples containing a tissue "core" (yes/no) for histological evaluation, defined as an intact piece of tissue of at least 550 μ'}], 'secondaryOutcomes': [{'measure': 'Tissue integrity', 'timeFrame': '6 months', 'description': 'Tissue integrity will be evaluated by attributing a score from zero to 3 (3 represents the better outcome), according to the following score system:\n\n0: No cells/tissue\n\n1. Cytological specimen (disaggregated cells representative of the target lesion not allowing for tissue architectural assessment)\n2. Histologic microfragments (sample adequate for histological evaluation, namely an architecturally intact piece of tissue but without a "core")\n3. Histologic "core" (defined as an architecturally intact piece of tissue measuring at least 550 μ)'}, {'measure': 'Blood contamination', 'timeFrame': '6 months', 'description': 'Blood contamination will be evaluated by attributing a score from zero to 3 (3 represents the better outcome), according to the following score system:\n\n0: Only blood\n\n1. High blood contamination (\\>50% of the surface)\n2. Moderate blood contamination (25-50% of the surface)\n3. Low blood contamination (\\<25% of the surface)'}, {'measure': 'Tumor fraction', 'timeFrame': '6 months', 'description': 'The rate of samples containing an adequate tumor fraction ≥20 percent (i.e., ≥ 20 percent tumor cells in a background of benign nucleated cells).'}, {'measure': 'Diagnostic accuracy', 'timeFrame': '6 months', 'description': 'Diagnostic accuracy (defined as the ratio between the sum of true positive and true negative values divided by the number of lesions) will be calculated for each study arm'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endoscopic Ultrasound', 'Fine-needle Aspiration']}, 'referencesModule': {'references': [{'pmid': '35915956', 'type': 'DERIVED', 'citation': 'Crino SF, Conti Bellocchi MC, Di Mitri R, Inzani F, Rimbas M, Lisotti A, Manfredi G, Teoh AYB, Mangiavillano B, Sendino O, Bernardoni L, Manfrin E, Scimeca D, Unti E, Carlino A, Voiosu T, Mateescu RB, Fusaroli P, Lega S, Buscarini E, Pergola L, Chan SM, Lamonaca L, Gines A, Fernandez-Esparrach G, Facciorusso A, Larghi A. Wet-suction versus slow-pull technique for endoscopic ultrasound-guided fine-needle biopsy: a multicenter, randomized, crossover trial. Endoscopy. 2023 Mar;55(3):225-234. doi: 10.1055/a-1915-1812. Epub 2022 Aug 1.'}]}, 'descriptionModule': {'briefSummary': 'A randomized cross-over study investigating the impact of two different suction techniques on histological yield and sample quality of specimens collected by endoscopic ultrasound biopsy from solid lesions using histology needles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Solid pancreatic lesions 3 1cm\n* Peri-GI tract lymph nodes 3 1cm\n* Peri-GI tract masses\n* Lesions of the GI wall\n* Signed informed consent\n\nExclusion Criteria:\n\n* Pancreatic cystic lesions (more than 50% of the volume)\n* Diameter of lesion ≤ 1 cm\n* Lesion not seen at EUS\n* Pregnancy\n* Coagulopathy (platelet count \\<50.000/mm3 and/or international normalized ratio \\>1.5);\n* Severe cardiorespiratory dysfunction precluding endoscopy;\n* Failure to provide informed consent'}, 'identificationModule': {'nctId': 'NCT04834193', 'acronym': 'WEST-FNB', 'briefTitle': 'Wet-suction Versus Slow-pull for EUS-FNB of Solid Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera Universitaria Integrata Verona'}, 'officialTitle': 'Wet-suction Versus Slow-pull Technique for Endoscopic Ultrasound-guided Fine-needle Biopsy of Solid Lesions: a Multicentric Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '18/22.09.2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WET-SUCTION', 'description': 'The stylet will be removed and the needle will be pre-flushed with 1-2mL of saline. The lesion will then be punctured, and suction will be applied using a 10-mL pre-vacuum syringe. The sample collected will be pushed into a formalin vial with saline.', 'interventionNames': ['Procedure: Endoscopic ultrasound-guided fine-needle biopsy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SLOW-PULL', 'description': 'After puncturing the lesion, the stylet will be slowly and gradually withdrawn for at least 40cm. The sample will be pushed into formalin using the stylet.', 'interventionNames': ['Procedure: Endoscopic ultrasound-guided fine-needle biopsy']}], 'interventions': [{'name': 'Endoscopic ultrasound-guided fine-needle biopsy', 'type': 'PROCEDURE', 'description': 'Solid lesions will be sampled under endoscopic ultrasound guidance using the two techniques (wet-suction and slow-pull)', 'armGroupLabels': ['SLOW-PULL', 'WET-SUCTION']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37134', 'city': 'Verona', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Integrata Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera Universitaria Integrata Verona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Stefano Francesco Crinò, MD', 'investigatorAffiliation': 'Azienda Ospedaliera Universitaria Integrata Verona'}}}}