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Contrast Enhanced Harmonic Endoscopic Ultrasound (CEH-EUS) in Focal Pancreatic Masses

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ClinicalTrials.gov Identifier: NCT01315548
Recruitment Status : Completed
First Posted : March 15, 2011
Last Update Posted : January 17, 2018
Information provided by (Responsible Party):

Study Description
Brief Summary:

The aim of the study is to assess the accuracy of real-time perfusion imaging pattern of pancreatic focal lesions visualized by contrast-enhanced harmonic endoscopic ultrasound (CEH-EUS) for the differential diagnosis between chronic pseudotumoral pancreatitis and pancreatic cancer in a prospective multicenter design.

The study will include patients with focal pancreatic masses evaluated by CEH-EUS and EUS-FNA. The diagnosis is usually unknown in the moment of the initial evaluation, the patients being included based on a suspicion of focal pancreatic masses after transabdominal ultrasound, CT or MR examinations. However, after a complete evaluation, a final diagnosis will be reached based on the combination of EUS-FNA cytology/pathology, surgical pathology and minimum 12 months follow-up.

Condition or disease
Adenocarcinoma Pancreas Chronic Pancreatitis

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Study Design

Study Type : Observational
Actual Enrollment : 210 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Contrast Enhanced Harmonic Endoscopic Ultrasound (CEH-EUS) Used in the Differentiation of Focal Pancreatic Masses
Study Start Date : March 2011
Primary Completion Date : April 2012
Study Completion Date : December 2012

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U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  1. Contrast enhanced harmonic endoscopic ultrasound [ Time Frame: Every six months ]
    Value of contrast enhanced harmonic endoscopic ultrasound for the differential diagnoses of pancreatic masses.

Biospecimen Retention:   Samples With 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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.


Inclusion Criteria:

  • Patients with suspicion of solid pancreatic tumor masses by previous cross-sectional imaging techniques (US, CT, MR)
  • Age 18 to 90 years old, men or women
  • Signed informed consent for EUS with contrast-enhancement, elastography and EUS-FNA

Exclusion Criteria:

  • Prior surgical treatment with curative intent or chemo-radiotherapy
  • Patients diagnosed with mucin producing tumors, pancreatic cystic tumors, etc.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01315548

Department of Surgical Gastroenterology, Gentofte & Herlev Hospital, University of Copenhagen
Copenhagen, Denmark
Center for Surgical Ultrasound, Department of Surgery, Odense University Hospital
Odense, Denmark
Paoli-Calmettes Institut
Marseilles, France
Caritas-Krankenhaus Bad Mergentheim
Bad Mergentheim, Germany
SRH Wald-Klinikum
Gera, Germany
Department of Internal Medicine II, Hospital Meiningen
Meiningen, Germany
Helios Klinikum, University of Witten/Herdecke
Wuppertal, Germany
Gastroenterology and Gastrointestinal Endoscopy Unit, Vita Salute San Raffaele University
Milan, Italy
Insitute of Medicine, University of Bergen and National Centre for Ultrasound in Gastroenterology, Haukeland University Hospital
Bergen, Norway
Center of Gastroenterology and Hepatology, Fundeni Clinical Institute
Bucharest, Romania
Gastroenterology Department, University of Medicine and Pharmacy
Craiova, Romania
University Hospital, Santiago de Compostela
Santiago de Compostela, Spain
United Kingdom
Hepatobiliary Surgery, Glasgow Royal Infirmary
Glasgow, United Kingdom
Institute of Hepatology, University College London
London, United Kingdom
Sponsors and Collaborators
University of Medicine and Pharmacy Craiova
Copenhagen University Hospital, Denmark
Caritas-Krankenhaus Bad Mergentheim
Institut Paoli-Calmettes
University of Witten/Herdecke
Hospital Meiningen Germany
Odense University Hospital
University of Santiago de Compostela
Università Vita-Salute San Raffaele
SRH Wald-Klinikum Gera GmbH
University of Bergen
Fundeni Clinical Institute of Digestive Diseases and Liver Transplant
Glasgow Royal Infirmary
University College, London
Study Director: Adrian Săftoiu, Professor University of Medicine and Pharmacy Craiova, Romania
More Information

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Medicine and Pharmacy Craiova
ClinicalTrials.gov Identifier: NCT01315548     History of Changes
Other Study ID Numbers: CEH-EUS-001
First Posted: March 15, 2011    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Keywords provided by University of Medicine and Pharmacy Craiova:
Contrast enhanced harmonic endoscopic ultrasound
Pancreatic adenocarcinoma
Chronic pancreatitis

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