Endoscopic Ultrasound Elastography in Pancreatic Masses
NCT ID: NCT00909103
Last Updated: 2010-01-12
Study Results
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Basic Information
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COMPLETED
285 participants
OBSERVATIONAL
2008-06-30
2009-12-31
Brief Summary
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Detailed Description
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Ultrasound elastography was previously used for the diagnosis of breast lesions, prostate cancer and thyroid nodules. However, the value of endoscopic ultrasound elastography for the diagnosis of pancreatic focal masses is not clear for the current moment, as some authors couldn't differentiate benign and malignant pancreatic tumors. Moreover, the intense fibrotic reaction and calcifications in chronic pancreatitis induce strain differences, and it is not clear if elastography is sensitive enough to detect them.
The study protocol is based on a semi-quantitative approach of EUS elastography data (movies) consisting of characterization of manually user-defined regions of interest, based on the hue histograms of the individual focal masses. Due to the inherent bias induced by selection of images from a dynamic sequence of EUS elastography, we have previously reported on the utility of using computer-aided diagnosis by averaging images from a dynamic sequence of EUS elastography. A special plugin (based on the ImageJ software, NIH, Bethesda, MD, USA) is used to compute hue histograms on average EUS elastography images, while the hue histograms values for each patient (0 to 255 values) are further used to classify the patients with benign and malignant lesions.
Ultrasound elastography will be performed during an usual EUS examination (7.5 MHz frequency), with two movies of 10 seconds recorded on the embedded HDD in order to minimize variability and to increase repeatability of acquisition. A two panel image with the usual conventional gray-scale B-mode EUS image on the right side and with the elastography image on the left side will be used. The region of interest will be preferably larger than the focal mass, in order to include the surrounding structures. In order to minimize the human bias, all the post-processing and computer analysis of digital movies will be performed within the IT Center in Craiova, with all programmers and statisticians being blinded to the clinical, pathological and imaging data, with the exception of the average hue histogram values calculated from a second region of interest manually traced around the focal mass.
The study design is prospective, blinded and multi-center, comparing endoscopic ultrasound elastography (EUS-EG) results for the detection and characterization of focal pancreatic masses by using artificial intelligence techniques, in comparison with the gold standard represented by pathology. The study will be performed with the approval of the institutional board review of each center.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Pancreatic adenocarcinoma
Patients diagnosed with solid pancreatic adenocarcinoma masses, with cytological / histological confirmation
No interventions assigned to this group
Chronic pancreatitis
Patients diagnosed with solid pancreatic tumor masses with all the criteria fulfilled to exclude pancreatic cancer
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age 18 to 80 years old, men or women
* Signed informed consent for EUS with elastography and FNA biopsy
Exclusion Criteria
* Patients diagnosed with mucin producing tumors, pancreatic cystic tumors, etc.
18 Years
80 Years
ALL
No
Sponsors
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University Hospital, Gentofte, Copenhagen
OTHER
Odense University Hospital
OTHER
Institut Paoli-Calmettes
OTHER
San Raffaele University Hospital, Italy
OTHER
UCL (Univ), Brussels, Belgium
UNKNOWN
Glasgow Royal Infirmary
OTHER
Caritas-Krankenhaus Bad Mergentheim
OTHER
University of Bergen
OTHER
University of Witten/Herdecke
OTHER
Newcastle-upon-Tyne Hospitals NHS Trust
OTHER
University of Medicine and Pharmacy Craiova
OTHER
Responsible Party
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University of Medicine and Pharmacy Craiova, Romania
Principal Investigators
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Adrian Saftoiu, Professor
Role: STUDY_DIRECTOR
University of Medicine and Pharmacy Craiova, Romania
Locations
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Erasme University
Brussels, , Belgium
Universite Chatolique Louvain
Brussels, , Belgium
Gentofte University Hospital
Copenhagen, , Denmark
University Hospital
Odense, , Denmark
Institute Paoli Calmettes
Marseille, , France
Caritas-Krankenhaus
Bad Mergentheim, , Germany
St. Josef Hospital
Bochum, , Germany
SRH Klinik
Gera, , Germany
University Clinic Mainz
Mainz, , Germany
Dr.Horst-Schmidt-Klinik
Wiesbaden, , Germany
HELIOS Klinikum Wuppertal, University of Witten/Herdecke
Wuppertal, , Germany
Hospital San Raffaele
Milan, , Italy
Erasme Medisch Centrum
Rotterdam, , Netherlands
University of Haukeland
Bergen, , Norway
University of Medicine and Pharmacy Craiova
Craiova, , Romania
University Hospital Santiago
Santiago, , Spain
Glasgow Royal Infirmary
Glasgow, , United Kingdom
Newcastle Upon Tyne Hospitals
Newcastle, , United Kingdom
Countries
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References
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Frey H. [Realtime elastography. A new ultrasound procedure for the reconstruction of tissue elasticity]. Radiologe. 2003 Oct;43(10):850-5. doi: 10.1007/s00117-003-0943-2. German.
Ophir J, Alam SK, Garra B, Kallel F, Konofagou E, Krouskop T, Varghese T. Elastography: ultrasonic estimation and imaging of the elastic properties of tissues. Proc Inst Mech Eng H. 1999;213(3):203-33. doi: 10.1243/0954411991534933.
Itoh A, Ueno E, Tohno E, Kamma H, Takahashi H, Shiina T, Yamakawa M, Matsumura T. Breast disease: clinical application of US elastography for diagnosis. Radiology. 2006 May;239(2):341-50. doi: 10.1148/radiol.2391041676. Epub 2006 Feb 16.
Miyanaga N, Akaza H, Yamakawa M, Oikawa T, Sekido N, Hinotsu S, Kawai K, Shimazui T, Shiina T. Tissue elasticity imaging for diagnosis of prostate cancer: a preliminary report. Int J Urol. 2006 Dec;13(12):1514-8. doi: 10.1111/j.1442-2042.2006.01612.x.
Rago T, Santini F, Scutari M, Pinchera A, Vitti P. Elastography: new developments in ultrasound for predicting malignancy in thyroid nodules. J Clin Endocrinol Metab. 2007 Aug;92(8):2917-22. doi: 10.1210/jc.2007-0641. Epub 2007 May 29.
Janssen J, Schlorer E, Greiner L. EUS elastography of the pancreas: feasibility and pattern description of the normal pancreas, chronic pancreatitis, and focal pancreatic lesions. Gastrointest Endosc. 2007 Jun;65(7):971-8. doi: 10.1016/j.gie.2006.12.057.
Saftoiu A, Vilmann P, Ciurea T, Popescu GL, Iordache A, Hassan H, Gorunescu F, Iordache S. Dynamic analysis of EUS used for the differentiation of benign and malignant lymph nodes. Gastrointest Endosc. 2007 Aug;66(2):291-300. doi: 10.1016/j.gie.2006.12.039.
Saftoiu A, Vilmann P, Gorunescu F, Janssen J, Hocke M, Larsen M, Iglesias-Garcia J, Arcidiacono P, Will U, Giovannini M, Dietrich CF, Havre R, Gheorghe C, McKay C, Gheonea DI, Ciurea T; European EUS Elastography Multicentric Study Group. Efficacy of an artificial neural network-based approach to endoscopic ultrasound elastography in diagnosis of focal pancreatic masses. Clin Gastroenterol Hepatol. 2012 Jan;10(1):84-90.e1. doi: 10.1016/j.cgh.2011.09.014. Epub 2011 Oct 1.
Saftoiu A, Vilmann P, Gorunescu F, Janssen J, Hocke M, Larsen M, Iglesias-Garcia J, Arcidiacono P, Will U, Giovannini M, Dietrich C, Havre R, Gheorghe C, McKay C, Gheonea DI, Ciurea T; European EUS Elastography Multicentric Study Group. Accuracy of endoscopic ultrasound elastography used for differential diagnosis of focal pancreatic masses: a multicenter study. Endoscopy. 2011 Jul;43(7):596-603. doi: 10.1055/s-0030-1256314. Epub 2011 Mar 24.
Related Links
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Related Info
Other Identifiers
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EUS-EG-UMFCV-RO
Identifier Type: -
Identifier Source: secondary_id
EUS-EG001
Identifier Type: -
Identifier Source: org_study_id
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