Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-03-04 @ 7:30 AM
Study NCT ID:
NCT02208518
Status:
COMPLETED
Last Update Posted:
2014-08-05
First Post:
2014-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantitative And Qualitative Eus Elastography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-04', 'studyFirstSubmitDate': '2014-03-04', 'studyFirstSubmitQcDate': '2014-08-04', 'lastUpdatePostDateStruct': {'date': '2014-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Highest compression rate of the probe', 'timeFrame': '4 weeks', 'description': 'the curve of the Highest compression rate of the probe: +0.4 , in the largest and smaller region of interest diameters'}, {'measure': 'Middle compression rate of the probe', 'timeFrame': '4 weeks', 'description': 'the curve of the Middle compression rate of the probe: 0: less than +0.4 and more than -0.4 \\[around baseline=0\\], in the largest and smaller region of interest diameters.'}, {'measure': 'Lower compression rate of the probe', 'timeFrame': '4 weeks', 'description': 'the curve of the Lower compression rate of the probe: -0.4 in the largest and smaller region of interest diameters'}, {'measure': 'Qualitative elastography', 'timeFrame': '8 weeks', 'description': 'Analysis for qualitative elastography was obtained by the predominant color of the pancreatic area studied.'}], 'primaryOutcomes': [{'measure': 'Quantitative Strain Ratio and qualitative Color endoscopy ultrasound elastography', 'timeFrame': 'two months', 'description': 'The quantitative Strain Ratio and qualitative Color endoscopy ultrasound elastography was measured in the normal body of the pancreas taking in consideration the curve of the compression rate probe high: +0.4 , middle: 0: less than +0.4 and more than -0.4 \\[around baseline=0\\], and low: -0.4 in the largest and smaller region of interest diameters. Analysis for qualitative color elastography was obtained by the predominant color of the pancreatic area studied. Pictures where recorded and quantitative strain ratio data were calculated comparing endoscopic ultrasound elastography of pancreatic tissue with soft tissue (normal mucosal layer: red).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Endoscopic Ultrasound elastography', 'Quantitative elastography', 'Qualitative elastography', 'Endoscopic Ultrasound', 'Elastography'], 'conditions': ['Normal Pancreatic Tissue']}, 'referencesModule': {'references': [{'pmid': '19899942', 'type': 'RESULT', 'citation': 'Iglesias Garcia JJ, Larino Noia J, Alvarez Castro A, Cigarran B, Dominguez Munoz JE. Second-generation endoscopic ultrasound elastography in the differential diagnosis of solid pancreatic masses. Pancreatic cancer vs. inflammatory mass in chronic pancreatitis. Rev Esp Enferm Dig. 2009 Oct;101(10):723-30. doi: 10.4321/s1130-01082009001000009. English, Spanish.'}, {'pmid': '20600020', 'type': 'RESULT', 'citation': 'Iglesias-Garcia J, Larino-Noia J, Abdulkader I, Forteza J, Dominguez-Munoz JE. Quantitative endoscopic ultrasound elastography: an accurate method for the differentiation of solid pancreatic masses. Gastroenterology. 2010 Oct;139(4):1172-80. doi: 10.1053/j.gastro.2010.06.059. Epub 2010 Jun 27.'}, {'pmid': '22854060', 'type': 'RESULT', 'citation': 'Dawwas MF, Taha H, Leeds JS, Nayar MK, Oppong KW. Diagnostic accuracy of quantitative EUS elastography for discriminating malignant from benign solid pancreatic masses: a prospective, single-center study. Gastrointest Endosc. 2012 Nov;76(5):953-61. doi: 10.1016/j.gie.2012.05.034. Epub 2012 Jul 31.'}, {'pmid': '16680632', 'type': 'RESULT', 'citation': 'Giovannini M, Hookey LC, Bories E, Pesenti C, Monges G, Delpero JR. Endoscopic ultrasound elastography: the first step towards virtual biopsy? Preliminary results in 49 patients. Endoscopy. 2006 Apr;38(4):344-8. doi: 10.1055/s-2006-925158.'}]}, 'descriptionModule': {'briefSummary': 'Endoscopic ultrasonography is considered the most accurate methods for the diagnosis and staging of chronic inflammatory and neoplastic pancreatic diseases. Differential diagnosis of solid pancreatic masses, however, remains a challenge and endoscopic ultrasound-guided fine needle aspiration is necessary. Recently, Endoscopic ultrasound elastography has been introduced as an alternative method to evaluate tissue stiffness of solid pancreatic masses, being an index of tissue elasticity, which may be related to histopathology features (hard tissue = blue = neoplastic and soft tissue = red-yellow-green = non-neoplastic). However, recently publications show different results using elastography. Moreover, a lack of data in Endoscopic ultrasound-elastography exist regarding the compression rate of the probe and the diameter of the region of interest under analysis in previously studies that by physics could affect the tissue elasticity.\n\nBased on the hypothesis that elastography could be affected by compression rate of the probe and the diameter of the region of interest analyzed the present study aimed to evaluate the quantitative (strain ratio) and qualitative endoscopic ultrasound-elastography results determined by the compression rate of the probe (measured by the curve of compression in the second generation of elastography) and the diameter of the region of interest in normal pancreatic tissue.', 'detailedDescription': 'prospective study performed in patients undergoing for upper-endoscopic ultrasound from October 31-to end of November 2013. Endoscopic ultrasound-elastography was performed using linear Pentax-EUS and "Hitachi-Avius". The quantitative-strain ratio and qualitative endoscopic ultrasound-elastography was measured in the body of the pancreas taking in consideration the curve of the compression rate of the probe high: +0.4, middle: 0, low: -0.4 in the largest and smaller region of interest diameters. Analysis for qualitative elastography was obtained by the predominant color of the pancreatic area studied. Pictures where recorded and quantitative strain ratio data were calculated comparing endoscopic ultrasound-elastography of pancreatic tissue with soft tissue (normal mucosal layer: red). Finally, a comparative analysis was performed between the results with the mean normal value for quantitative strain ratio previously published for normal pancreatic tissue, and between the different compression rates of the probe.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'primary care clinic: patients with upper gastrointestinal submucosal tumors for evaluation by endoscopic ultrasound', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Endoscopic Ultrasound for evaluate submucosal tumors\n\nExclusion Criteria:\n\n* age\\<18 or \\> 55; pregnancy\n* history of: pancreatic disease\n* choledocolithiasis\n* symptoms of maldigestion\n* alcohol abuse\n* increased serum levels of pancreatic enzymes\n* smokers\n* Endoscopic Ultrasound with signs of chronic pancreatitis (Rosemont classification)'}, 'identificationModule': {'nctId': 'NCT02208518', 'briefTitle': 'Quantitative And Qualitative Eus Elastography', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Ecuatoriano de Enfermedades Digestivas'}, 'officialTitle': 'Could Quantitative And Qualitative EUS-Elastography Results Be Affected By The Compression Rate And The Diameter Of The Region Of Interest (ROI)?', 'orgStudyIdInfo': {'id': 'ELASTOSONO-EUS1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Elastography analysis', 'description': 'Consecutive patients undergoing for upper endoscopy ultrasound', 'interventionNames': ['Procedure: endoscopy ultrasound elastography', 'Device: EUS-elastography']}], 'interventions': [{'name': 'endoscopy ultrasound elastography', 'type': 'PROCEDURE', 'description': 'During a endoscopy ultrasound (EUS) procedure, in patients with normal pancreas at EUS, elastography was performed using a software already included in Hitachi-Avius machine, pressing the button and obtaining colors and pressure curve given by the software', 'armGroupLabels': ['Elastography analysis']}, {'name': 'EUS-elastography', 'type': 'DEVICE', 'armGroupLabels': ['Elastography analysis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1301266', 'city': 'Guayaquil', 'state': 'Guayas', 'country': 'Ecuador', 'facility': 'Instituto Ecuatoriano de Enfermedades Digestivas', 'geoPoint': {'lat': -2.19616, 'lon': -79.88621}}], 'overallOfficials': [{'name': 'Carlos Robles-Medranda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Ecuatoriano de Enfermedades Digestivas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Ecuatoriano de Enfermedades Digestivas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}