Endoscopic Ultrasound Elastography in Pancreatic Masses

Pancreatic Adenocarcinoma Clinical Trial

— EUS-EG  

Official title:

Computer-aided Diagnosis of Endoscopic Ultrasound Elastography Used in the Differentiation of Focal Pancreatic Masses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00909103
• Other study ID #: EUS-EG001
• Secondary ID: EUS-EG-UMFCV-RO
• Status: Completed
• Phase: N/A
• First received: May 25, 2009
• Last updated: January 11, 2010
• Start date: June 2008
• Est. completion date: December 2009

Study information

• Verified date: January 2010
• Source: University of Medicine and Pharmacy Craiova
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: Ministry of Public Health
• Study type: Observational

Clinical Trial Summary

The aim of the study is to assess elastography during EUS examinations of focal pancreatic masses, and to consequently differentiate benign versus malignant pancreatic masses in a prospective multi-center design.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adenocarcinoma
• Chronic Pancreatitis
• Pancreatic Adenocarcinoma
• Pancreatitis
• Pancreatitis, Chronic

Locations

Country	Name	City	State
Belgium	Erasme University	Brussels
Belgium	Universite Chatolique Louvain	Brussels
Denmark	Gentofte University Hospital	Copenhagen
Denmark	University Hospital	Odense
France	Institute Paoli Calmettes	Marseille
Germany	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
Italy	Hospital San Raffaele	Milan
Netherlands	Erasme Medisch Centrum	Rotterdam
Norway	University of Haukeland	Bergen
Romania	University of Medicine and Pharmacy Craiova	Craiova
Spain	University Hospital Santiago	Santiago
United Kingdom	Glasgow Royal Infirmary	Glasgow
United Kingdom	Newcastle Upon Tyne Hospitals	Newcastle

Sponsors (11)

Lead Sponsor	Collaborator
University of Medicine and Pharmacy Craiova	Caritas-Krankenhaus Bad Mergentheim, Glasgow Royal Infirmary, Institut Paoli-Calmettes, Newcastle-upon-Tyne Hospitals NHS Trust, Odense University Hospital, San Raffaele University Hospital, Italy, UCL (Univ), Brussels, Belgium, University Hospital, Gentofte, Copenhagen, University of Bergen, University of Witten/Herdecke

Countries where clinical trial is conducted

Belgium,  Denmark,  France,  Germany,  Italy,  Netherlands,  Norway,  Romania,  Spain,  United Kingdom, 

References & Publications (7)

Frey H. [Realtime elastography. A new ultrasound procedure for the reconstruction of tissue elasticity]. Radiologe. 2003 Oct;43(10):850-5. German. — View Citation

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. Epub 2006 Feb 16. — View Citation

Janssen J, Schlörer 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Epub 2007 May 29. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Value of endoscopic ultrasound elastography for the differential diagnoses of pancreatic masses.		18 months	No

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