protocolSection identificationModule nctId: NCT06298604, orgStudyIdInfo id: IECED-12112023, briefTitle: Motorized Fine Needle Biopsy vs Standard Needles, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-09, primaryCompletionDateStruct date: 2024-10-09, completionDateStruct date: 2024-12-09, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Instituto Ecuatoriano de Enfermedades Digestivas, class: OTHER, 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.Given 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., conditionsModule conditions: Pancreas Disease, conditions: Liver Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective, diagnostic,, cross-sectional study, primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, maskingDescription: Single masking, the pathologist will be blinded to the needle used for sample collection., whoMasked: CARE_PROVIDER, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: EUS-guided standard fine needle biopsy, interventions name: EUS-guided motorized fine needle biopsy, outcomesModule primaryOutcomes measure: Endoscopic ultrasound fine needle biopsy sample quality, primaryOutcomes measure: Diagnostic accuracy according to histological analysis, secondaryOutcomes measure: Tissue blood contamination, otherOutcomes measure: Time efficiency during tissue acquisition, otherOutcomes measure: Rate of liver specimen adequacy, otherOutcomes measure: Rate of adverse events associated with the procedure, otherOutcomes measure: Quality of cytologic sample, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Instituto Ecuatoriano de Enfermedades Digestivas (IECED), status: RECRUITING, city: Guayaquil, zip: 090505, country: Ecuador, contacts name: Carlos Robles-Medranda, MD FASGE, role: CONTACT, phone: +593989158865, email: carlosoakm@yahoo.es, contacts name: Carlos Robles-Medranda, MD FASGE, role: PRINCIPAL_INVESTIGATOR, contacts name: Raquel Del Valle, MD, role: SUB_INVESTIGATOR, contacts name: Maria Egas-Izquierdo, MD, role: SUB_INVESTIGATOR, contacts name: Jorge Baquerizo-Burgos, MD, role: SUB_INVESTIGATOR, contacts name: Domenica Cunto, MD, role: SUB_INVESTIGATOR, contacts name: Juan Alcivar-Vasquez, MD, role: SUB_INVESTIGATOR, contacts name: Daniela Tabacelia, MD, role: SUB_INVESTIGATOR, contacts name: Martha Arevalo-Mora, MD, role: SUB_INVESTIGATOR, contacts name: Miguel Puga-Tejada, MD, role: SUB_INVESTIGATOR, contacts name: Gustavo Rubio, MD, role: SUB_INVESTIGATOR, contacts name: Hannah Pitanga-Lukashok, MD, role: SUB_INVESTIGATOR, geoPoint lat: -2.20584, lon: -79.90795, hasResults: False