Endoscopic Ultrasound Elastography in Pancreatic Masses (EUS-EG)

January 11, 2010 updated by: University of Medicine and Pharmacy Craiova

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

285

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Erasme University
      • Brussels, Belgium
        • Universite Chatolique Louvain
  • Denmark
      • Copenhagen, Denmark
        • Gentofte University Hospital
      • Odense, Denmark
        • University Hospital
  • France
      • Marseille, France
        • Institute Paoli Calmettes
  • Germany
      • Bad Mergentheim, Germany
        • Caritas-Krankenhaus
      • Bochum, Germany
        • St. Josef Hospital
      • Gera, Germany
        • SRH Klinik
      • Mainz, Germany
        • University Clinic Mainz
      • Wiesbaden, Germany
        • Dr.Horst-Schmidt-Klinik
      • Wuppertal, Germany
        • HELIOS Klinikum Wuppertal, University of Witten/Herdecke
  • Italy
      • Milan, Italy
        • Hospital San Raffaele
  • Netherlands
      • Rotterdam, Netherlands
        • Erasme Medisch Centrum
  • Norway
      • Bergen, Norway
        • University of Haukeland
  • Romania
      • Craiova, Romania
        • University of Medicine and Pharmacy Craiova
  • Spain
      • Santiago, Spain
        • University Hospital Santiago
  • United Kingdom
      • Glasgow, United Kingdom
        • Glasgow Royal Infirmary
      • Newcastle, United Kingdom
        • Newcastle Upon Tyne Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Chronic pancreatitis
Patients diagnosed with solid pancreatic tumor masses with all the criteria fulfilled to exclude pancreatic cancer
Pancreatic adenocarcinoma
Patients diagnosed with solid pancreatic adenocarcinoma masses, with cytological / histological confirmation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Value of endoscopic ultrasound elastography for the differential diagnoses of pancreatic masses.
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Pharmacy Craiova

Collaborators

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

Investigators

  • Study Director: Adrian Saftoiu, Professor, University of Medicine and Pharmacy Craiova, Romania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

May 25, 2009

First Submitted That Met QC Criteria

May 26, 2009

First Posted (Estimate)

May 27, 2009

Study Record Updates

Last Update Posted (Estimate)

January 12, 2010

Last Update Submitted That Met QC Criteria

January 11, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUS-EG001
  • EUS-EG-UMFCV-RO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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