Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-29 @ 10:02 PM
Study NCT ID:
NCT06298604
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motorized Fine Needle Biopsy vs Standard Needles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': 'Single masking, the pathologist will be blinded to the needle used for sample collection.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, diagnostic,, cross-sectional study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-20', 'studyFirstSubmitDate': '2024-03-01', 'studyFirstSubmitQcDate': '2024-03-01', 'lastUpdatePostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time efficiency during tissue acquisition', 'timeFrame': 'Up to two hours', 'description': 'The tissue from identifying the lesion to obtaining the sample. It will be calculated in minutes'}, {'measure': 'Rate of liver specimen adequacy', 'timeFrame': 'Up to 1 week', 'description': 'Intact liver cores of at least 15-20 mm with a complete portal triad count of 11'}, {'measure': 'Rate of adverse events associated with the procedure', 'timeFrame': 'Up to 6 months', 'description': 'Adverse event associated with the procedure, including transprocedural, early, and late post-procedural occurrence'}, {'measure': 'Quality of cytologic sample', 'timeFrame': 'Up to 2 hours', 'description': 'The quality of the cytologic sample will be scored according to the pathologist criteria as:\n\n0= insufficient material for cytologic interpretation\n\n1. sufficient material for limited cytologic interpretation\n2. sufficient material for adequate cytologic interpretation'}], 'primaryOutcomes': [{'measure': 'Endoscopic ultrasound fine needle biopsy sample quality', 'timeFrame': 'Up to two hours after the procedures', 'description': 'Based on tissue "core"; Tissue core is defined as a architecturally intact piece of at least 550 micron in the greatest axis. The tissue core will be evaluated in both groups by the pathologist immediately after its acquisition.'}, {'measure': 'Diagnostic accuracy according to histological analysis', 'timeFrame': 'Up to one week', 'description': 'Proportion of subjects with a definitive diagnosis based on the number of passes and throws for tissue acquisition.'}], 'secondaryOutcomes': [{'measure': 'Tissue blood contamination', 'timeFrame': 'Up to one hour', 'description': 'Evaluation of tissue blood contamination will be based on a sample quality score:\n\n1. Only blood\n2. High (\\>50% of the surface of the slide)\n3. Moderate (25%-50% of the surface of the slide)\n4. Low (\\<25% of the surface of the slide)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fine-needle biopsy', 'Endosonography', 'liver', 'pancreas', 'pathology'], 'conditions': ['Pancreas Disease', 'Liver Diseases']}, 'referencesModule': {'references': [{'pmid': '34859313', 'type': 'BACKGROUND', 'citation': 'Mendoza Ladd A, Casner N, Cherukuri SV, Garcia C, Padilla O, Dwivedi A, Hakim N. Fine Needle Biopsies of Solid Pancreatic Lesions: Tissue Acquisition Technique and Needle Design Do Not Impact Specimen Adequacy. Dig Dis Sci. 2022 Sep;67(9):4549-4556. doi: 10.1007/s10620-021-07316-4. Epub 2021 Dec 2.'}, {'pmid': '31601535', 'type': 'BACKGROUND', 'citation': 'Di Mitri R, Mocciaro F, Antonini F, Scimeca D, Conte E, Bonaccorso A, Scibetta N, Unti E, Fornelli A, Giorgini S, Binda C, Macarri G, Larghi A, Fabbri C. Stylet slow-pull vs. standard suction technique for endoscopic ultrasound-guided fine needle biopsy in pancreatic solid lesions using 20 Gauge Procore needle: A multicenter randomized trial. Dig Liver Dis. 2020 Feb;52(2):178-184. doi: 10.1016/j.dld.2019.08.023. Epub 2019 Oct 7.'}, {'pmid': '35898843', 'type': 'BACKGROUND', 'citation': 'Fujita A, Ryozawa S, Tanisaka Y, Ogawa T, Saito Y, Katsuda H, Miyaguchi K, Yasuda M, Araki R, Mashimo Y, Tashima T, Nakano Y, Terada R, Jinushi R, Mizuide M. Comparison of Fork-tip and Franseen needles for endoscopic ultrasound-guided fine-needle biopsy in pancreatic solid lesions: A propensity-matched analysis. DEN Open. 2022 Jun 28;3(1):e147. doi: 10.1002/deo2.147. eCollection 2023 Apr.'}]}, 'descriptionModule': {'briefSummary': 'Recent improvements in punctures techniques and needles now allow for the collection of high-quality specimens comparable to core needle biopsy. A newly developed motorized fine needle biopsy (mFNB), the Precision-GI (Limaca, Israel) promises intact tissue acquisition without sample damage, relying on controlled axial tissue cutting and high-speed rotational coring for optimized tissue acquisition.\n\nGiven the advancement mentioned, the investigators aim to compare the performance of the mFNB with the standard needle during the acquisition of endoscopic ultrasound (EUS)-guided pancreatic and liver specimens through a prospective, interventional, single-center trial. The study will consist of two groups of patients: one assigned to the standard fine needle biopsy (FNB) and the other to the mFNB. The primary study outcomes will include sample quality (core integrity), and diagnostic accuracy.', 'detailedDescription': 'The development of Endoscopic ultrasound-guided tissue acquisition (EUS-TA) has been remarkable. Initially focused on obtaining samples from the pancreas, it has expanded significantly to include various organs adjacent to the gastrointestinal system (i.e., liver, lymph nodes, adrenal glands).\n\nOne of the key advancements in EUS-TA involves the shift from cytological analysis, with fine-needle aspiration (FNA), to histological and even genetic evaluations, with fine-needle biopsies (FNB). FNB addresses some limitations associated with FNA, such as low tumor cellularity and the inability to retain cellular architecture.\n\nRecent improvements in puncture techniques and needles, allow for the collection of high-quality specimens, comparable to core needle biopsy, to achieve standards for specimen adequacy (i.e., intact liver cores of at least 15-20 mm with a complete portal triad count of 11). Some current available needle designs include the crown type, flanged type, 20 Gauge FNB needles with forward-faced core traps, and the fork-tip needles, demonstrating high diagnostic accuracy and a low rate of adverse events.\n\nThe Precision-GI is a new motorized fine needle (mFNB) developed by LIMACA Medical in Israel for EUS-guided FNB. It operates using a battery-powered motor that enables controlled axial tissue cutting and high-speed rotational coring for optimized tissue acquisition. Moreover, a sharp stylet facilitates crossing through the gastrointestinal wall, allowing for the reach of target lesions. The rotational electromechanical cutting movement into the lesion promises intact motorized tissue acquisition without sample damage.\n\nIn the present study, the investigators aim to compare the performance of the mFNB with the standard needle during the acquisition of EUS-guided pancreatic and liver specimens. The study will consist of two groups of patients: one assigned to the standard fine needle biopsy (FNB) and the other to the mFNB. The primary study outcomes will include sample quality (core integrity), and diagnostic accuracy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between 18 and 99 years\n* Patients referred to our center who require EUS-guided liver or pancreas biopsy.\n* Male or female patients.\n* Patients able to give consent\n\nExclusion Criteria:\n\n* Pregnancy or nursing\n* Patients with coagulation disorders (platelets \\<50.000/mm3, international normalised ratio (INR) \\>2)\n* Any underlying medical condition that contraindicates EUS-guided fine needle biopsy such as anatomical alterations, significant gastric outlet obstruction, collateral intervening vessels.'}, 'identificationModule': {'nctId': 'NCT06298604', 'briefTitle': 'Motorized Fine Needle Biopsy vs Standard Needles', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Ecuatoriano de Enfermedades Digestivas'}, 'officialTitle': 'Comparison Between a Novel Motorized EUS Guided Fine Needle Biopsy (FNB) With Standard Needle for Pancreatic and Liver Biopsies', 'orgStudyIdInfo': {'id': 'IECED-12112023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard EUS-guided FNB', 'description': 'Patients scheduled for EUS-guided liver or pancreas biopsy will undergo the procedure using a standard 19-gauge needle', 'interventionNames': ['Device: EUS-guided standard fine needle biopsy']}, {'type': 'EXPERIMENTAL', 'label': 'Motorized EUS-guided FNB', 'description': 'Patients scheduled for EUS-guided liver or pancreas biopsy will undergo the procedure using a motorized 20-gauge needle.', 'interventionNames': ['Device: EUS-guided motorized fine needle biopsy']}], 'interventions': [{'name': 'EUS-guided standard fine needle biopsy', 'type': 'DEVICE', 'description': 'Using the echoendoscope, a pancreatic lesion or liver parenchyma will be identified, and a 19-gauge standard fine needle biopsy device (Boston Scientific, USA) is inserted on it to obtain the sample or specimen.', 'armGroupLabels': ['Standard EUS-guided FNB']}, {'name': 'EUS-guided motorized fine needle biopsy', 'type': 'DEVICE', 'description': 'Using the echoendoscope, a pancreatic lesion or liver parenchyma will be identified, and a 20-gauge motorized fine needle biopsy device (Limaca, Israel) is inserted on it to obtain the sample or specimen.', 'armGroupLabels': ['Motorized EUS-guided FNB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '090505', 'city': 'Guayaquil', 'status': 'RECRUITING', 'country': 'Ecuador', 'contacts': [{'name': 'Carlos Robles-Medranda, MD FASGE', 'role': 'CONTACT', 'email': 'carlosoakm@yahoo.es', 'phone': '+593989158865'}, {'name': 'Carlos Robles-Medranda, MD FASGE', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Raquel Del Valle, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Maria Egas-Izquierdo, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jorge Baquerizo-Burgos, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Domenica Cunto, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Juan Alcivar-Vasquez, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Daniela Tabacelia, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Martha Arevalo-Mora, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Miguel Puga-Tejada, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gustavo Rubio, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hannah Pitanga-Lukashok, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Instituto Ecuatoriano de Enfermedades Digestivas (IECED)', 'geoPoint': {'lat': -2.19616, 'lon': -79.88621}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Ecuatoriano de Enfermedades Digestivas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Endoscopy Division', 'investigatorFullName': 'Carlos Robles-Medranda', 'investigatorAffiliation': 'Instituto Ecuatoriano de Enfermedades Digestivas'}}}}