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

NCT01315548 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 210

Last updated 2018-01-17

No results posted yet for this study

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.

Conditions

  • Adenocarcinoma Pancreas
  • Chronic Pancreatitis

Sponsors & Collaborators

  • Copenhagen University Hospital, Denmark

    collaborator OTHER
  • Caritas-Krankenhaus Bad Mergentheim

    collaborator OTHER
  • Institut Paoli-Calmettes

    collaborator OTHER
  • University of Witten/Herdecke

    collaborator OTHER
  • Hospital Meiningen Germany

    collaborator UNKNOWN
  • Odense University Hospital

    collaborator OTHER
  • University of Santiago de Compostela

    collaborator OTHER
  • Università Vita-Salute San Raffaele

    collaborator OTHER
  • SRH Wald-Klinikum Gera GmbH

    collaborator OTHER
  • University of Bergen

    collaborator OTHER
  • Institutul Clinic Fundeni

    collaborator OTHER
  • Glasgow Royal Infirmary

    collaborator OTHER
  • University College, London

    collaborator OTHER
  • University of Medicine and Pharmacy Craiova

    lead OTHER

Principal Investigators

  • Adrian Săftoiu, Professor · University of Medicine and Pharmacy Craiova, Romania

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-04-30
Completion
2012-12-31

Countries

  • Denmark
  • France
  • Germany
  • Italy
  • Norway
  • Romania
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01315548 on ClinicalTrials.gov