Endoscopic Ultrasound Elastography in Pancreatic Masses (EUS-EG)
Computer-aided Diagnosis of Endoscopic Ultrasound Elastography Used in the Differentiation of Focal Pancreatic Masses
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Ultrasound elastography is a recent ultrasound method used for the calculation of tissue elasticity distribution in real-time. The method allows the reconstruction of tissue elasticity (i.e. the elasticity modulus) and reveals directly the physical properties of the tissue, consequently showing different tissue hardness patterns that are determined by diseases. Tissue elastography can be easily performed real-time with conventional probes, including the linear EUS probes used for the examination of the pancreas. The calculation of tissue elasticity distribution is performed in real-time and the examination results are represented as transparent overlay colour images overimposed on the conventional gray-scale B-mode images.
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Bad Mergentheim, Allemagne
- Caritas-Krankenhaus
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Bochum, Allemagne
- St. Josef Hospital
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Gera, Allemagne
- SRH Klinik
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Mainz, Allemagne
- University Clinic Mainz
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Wiesbaden, Allemagne
- Dr.Horst-Schmidt-Klinik
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Wuppertal, Allemagne
- HELIOS Klinikum Wuppertal, University of Witten/Herdecke
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Brussels, Belgique
- Erasme University
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Brussels, Belgique
- Universite Chatolique Louvain
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Copenhagen, Danemark
- Gentofte University Hospital
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Odense, Danemark
- University Hospital
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Santiago, Espagne
- University Hospital Santiago
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Marseille, France
- Institute Paoli Calmettes
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Milan, Italie
- Hospital San Raffaele
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Bergen, Norvège
- University of Haukeland
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Rotterdam, Pays-Bas
- Erasme Medisch Centrum
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Craiova, Roumanie
- University of Medicine and Pharmacy Craiova
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Glasgow, Royaume-Uni
- Glasgow Royal Infirmary
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Newcastle, Royaume-Uni
- Newcastle upon Tyne Hospitals
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
The diagnosis of chronic pancreatitis will be based on the clinical information (history of alcohol abuse, previous diagnosis of chronic pancreatitis or diabetes mellitus), as well as a combination of imaging methods (ultrasound, CT and EUS). At least four criteria of chronic pancreatitis during EUS will be considered for the positive diagnosis.
A positive cytological diagnosis will be taken as a final proof of malignancy of the pancreas mass. The diagnoses obtained by EUS-FNA will be further verified either by surgery or during a clinical follow-up of at least 6 months.
La description
Inclusion criteria
- Patients diagnosed with solid pancreatic tumor masses, with cytological / histological confirmation
- Age 18 to 80 years old, men or women
- Signed informed consent for EUS with elastography and FNA biopsy
Exclusion criteria
- Prior surgical treatment with curative intent or chemo-radiotherapy
- Patients diagnosed with mucin producing tumors, pancreatic cystic tumors, etc.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Pancréatite chronique
Patients diagnostiqués avec des masses tumorales pancréatiques solides avec tous les critères remplis pour exclure le cancer du pancréas
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Pancreatic adenocarcinoma
Patients diagnosed with solid pancreatic adenocarcinoma masses, with cytological / histological confirmation
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Value of endoscopic ultrasound elastography for the differential diagnoses of pancreatic masses.
Délai: 18 months
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18 months
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Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Directeur d'études: Adrian Saftoiu, Professor, University of Medicine and Pharmacy Craiova, Romania
Publications et liens utiles
Publications générales
- 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.
- 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.
- 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.
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- EUS-EG001
- EUS-EG-UMFCV-RO
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