Endoscopic Ultrasound Elastography in Pancreatic Masses (EUS-EG)

This study has been completed.
Sponsor:
Collaborators:
University Hospital, Gentofte, Copenhagen
Odense University Hospital
Institut Paoli-Calmettes
San Raffaele University Hospital, Italy
UCL (Univ), Brussels, Belgium
Glasgow Royal Infirmary
Caritas-Krankenhaus, Bad Mergentheim, Germany
University of Bergen
University of Witten/Herdecke
Newcastle-upon-Tyne Hospitals NHS Trust
Information provided by:
University of Medicine and Pharmacy Craiova
ClinicalTrials.gov Identifier:
NCT00909103
First received: May 25, 2009
Last updated: January 11, 2010
Last verified: January 2010
  Purpose

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.


Condition
Pancreatic Adenocarcinoma
Chronic Pancreatitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Computer-aided Diagnosis of Endoscopic Ultrasound Elastography Used in the Differentiation of Focal Pancreatic Masses

Resource links provided by NLM:


Further study details as provided by University of Medicine and Pharmacy Craiova:

Primary Outcome Measures:
  • Value of endoscopic ultrasound elastography for the differential diagnoses of pancreatic masses. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Pathology samples obtained from duodeno-pancreatectomies or caudal pancreatectomies done with curative intent, as well as microhistological fragments obtained through EUS-FNA biopsy processed by paraffin embedding


Enrollment: 285
Study Start Date: June 2008
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pancreatic adenocarcinoma
Patients diagnosed with solid pancreatic adenocarcinoma masses, with cytological / histological confirmation
Chronic pancreatitis
Patients diagnosed with solid pancreatic tumor masses with all the criteria fulfilled to exclude pancreatic cancer

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00909103

Locations
Belgium
Universite Chatolique Louvain
Brussels, Belgium
Erasme University
Brussels, Belgium
Denmark
Gentofte University Hospital
Copenhagen, Denmark
University Hospital
Odense, Denmark
France
Institute Paoli Calmettes
Marseille, France
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, Germany
Italy
Hospital San Raffaele
Milan, Italy
Netherlands
Erasme Medisch Centrum
Rotterdam, Netherlands
Norway
University of Haukeland
Bergen, Norway
Romania
University of Medicine and Pharmacy Craiova
Craiova, Romania
Spain
University Hospital Santiago
Santiago, Spain
United Kingdom
Glasgow Royal Infirmary
Glasgow, United Kingdom
Newcastle Upon Tyne Hospitals
Newcastle, United Kingdom
Sponsors and Collaborators
University of Medicine and Pharmacy Craiova
University Hospital, Gentofte, Copenhagen
Odense University Hospital
Institut Paoli-Calmettes
San Raffaele University Hospital, Italy
UCL (Univ), Brussels, Belgium
Glasgow Royal Infirmary
Caritas-Krankenhaus, Bad Mergentheim, Germany
University of Bergen
University of Witten/Herdecke
Newcastle-upon-Tyne Hospitals NHS Trust
Investigators
Study Director: Adrian Saftoiu, Professor University of Medicine and Pharmacy Craiova, Romania
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Adrian Saftoiu, University of Medicine and Pharmacy Craiova, Romania
ClinicalTrials.gov Identifier: NCT00909103     History of Changes
Other Study ID Numbers: EUS-EG001, EUS-EG-UMFCV-RO
Study First Received: May 25, 2009
Last Updated: January 11, 2010
Health Authority: Romania: Ministry of Public Health

Keywords provided by University of Medicine and Pharmacy Craiova:
Endoscopic Ultrasound Elastography
Pancreatic adenocarcinoma
Chronic Pancreatitis

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatitis
Pancreatitis, Chronic
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 01, 2014