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

This study has been completed.
Sponsor:
Collaborators:
Copenhagen University Hospital, Denmark
Caritas-Krankenhaus, Bad Mergentheim, Germany
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 Germany
University of Bergen
Fundeni Clinical Institute of Digestive Diseases and Liver Transplant
Glasgow Royal Infirmary
University College, London
Information provided by (Responsible Party):
University of Medicine and Pharmacy Craiova
ClinicalTrials.gov Identifier:
NCT01315548
First received: March 13, 2011
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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
Adenocarcinoma Pancreas
Chronic Pancreatitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Contrast Enhanced Harmonic Endoscopic Ultrasound (CEH-EUS) 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:
  • Contrast enhanced harmonic endoscopic ultrasound [ Time Frame: Every six months ] [ Designated as safety issue: No ]
    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


Enrollment: 210
Study Start Date: March 2011
Study Completion Date: December 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 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 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
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: NCT01315548

Locations
Denmark
Department of Surgical Gastroenterology, Gentofte & Herlev Hospital, University of Copenhagen
Copenhagen, Denmark
Center for Surgical Ultrasound, Department of Surgery, Odense University Hospital
Odense, Denmark
France
Paoli-Calmettes Institut
Marseilles, France
Germany
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
Italy
Gastroenterology and Gastrointestinal Endoscopy Unit, Vita Salute San Raffaele University
Milan, Italy
Norway
Insitute of Medicine, University of Bergen and National Centre for Ultrasound in Gastroenterology, Haukeland University Hospital
Bergen, Norway
Romania
Center of Gastroenterology and Hepatology, Fundeni Clinical Institute
Bucharest, Romania
Gastroenterology Department, University of Medicine and Pharmacy
Craiova, Romania
Spain
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, Germany
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 Germany
University of Bergen
Fundeni Clinical Institute of Digestive Diseases and Liver Transplant
Glasgow Royal Infirmary
University College, London
Investigators
Study Director: Adrian Săftoiu, Professor University of Medicine and Pharmacy Craiova, Romania
  More Information

Additional Information:
Publications:

Responsible Party: University of Medicine and Pharmacy Craiova
ClinicalTrials.gov Identifier: NCT01315548     History of Changes
Other Study ID Numbers: CEH-EUS-001, CEH-EUS-UMFCV-RO
Study First Received: March 13, 2011
Last Updated: April 7, 2014
Health Authority: Romania: Ministry of Education, Research, Youth and Sport

Keywords provided by University of Medicine and Pharmacy Craiova:
Contrast enhanced harmonic endoscopic ultrasound
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 October 01, 2014