Contrast Enhanced Harmonic Endoscopic Ultrasound (CEH-EUS) in Focal Pancreatic Masses
This study is currently recruiting participants.
Verified March 2012 by University of Medicine and Pharmacy Craiova
Sponsor:
University of Medicine and Pharmacy Craiova
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: March 31, 2012
Last verified: March 2012
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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
| Estimated Enrollment: | 210 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01315548
Contacts
| Contact: Adrian Saftoiu, Professor | +40744823355 | adriansaftoiu@netscape.net |
| Contact: Dan Gheonea, Teaching Assitant | +40751268731 | digheonea@gmail.com |
Locations
| Denmark | |
| Department of Surgical Gastroenterology, Gentofte & Herlev Hospital, University of Copenhagen | Recruiting |
| Copenhagen, Denmark | |
| Contact: Peter Vilmann pevi@geh.regionh.dk | |
| Center for Surgical Ultrasound, Department of Surgery, Odense University Hospital | Recruiting |
| Odense, Denmark | |
| Contact: Claus Fristrup claus@fristrup.net | |
| France | |
| Paoli-Calmettes Institut | Recruiting |
| Marseilles, France | |
| Contact: Marc Giovannini giovanninim@wanadoo.fr | |
| Germany | |
| Caritas-Krankenhaus Bad Mergentheim | Recruiting |
| Bad Mergentheim, Germany | |
| Contact: Cristoph Dietrich Christoph.Dietrich@ckbm.de | |
| SRH Wald-Klinikum | Recruiting |
| Gera, Germany | |
| Contact: Uwe Will uwe.will@wkg.srh.de | |
| Department of Internal Medicine II, Hospital Meiningen | Recruiting |
| Meiningen, Germany | |
| Contact: Michael Hocke Michael.hocke@klinikum-meiningen.de | |
| Helios Klinikum, University of Witten/Herdecke | Recruiting |
| Wuppertal, Germany | |
| Contact: Jan Janssen jan.janssen@helios-kliniken.de | |
| Italy | |
| Gastroenterology and Gastrointestinal Endoscopy Unit, Vita Salute San Raffaele University | Recruiting |
| Milan, Italy | |
| Contact: Paolo Arcidiacono arcidiacono.paologiorgio@hsr.it | |
| Norway | |
| Insitute of Medicine, University of Bergen and National Centre for Ultrasound in Gastroenterology, Haukeland University Hospital | Recruiting |
| Bergen, Norway | |
| Contact: Roald Havre roald.flesland.havre@helse-bergen.no | |
| Romania | |
| Center of Gastroenterology and Hepatology, Fundeni Clinical Institute | Recruiting |
| Bucharest, Romania | |
| Contact: Cristian Gheorghe drgheorghe@xnet.ro | |
| Gastroenterology Department, University of Medicine and Pharmacy | Recruiting |
| Craiova, Romania | |
| Contact: Dan Gheonea +40751268731 digheonea@gmail.com | |
| Sub-Investigator: Costin Streba, PhD | |
| Spain | |
| University Hospital, Santiago de Compostela | Recruiting |
| Santiago de Compostela, Spain | |
| Contact: Julio Iglesias-Garcia Julio.Iglesias.Garcia@sergas.es | |
| United Kingdom | |
| Hepatobiliary Surgery, Glasgow Royal Infirmary | Recruiting |
| Glasgow, United Kingdom | |
| Contact: Colin McKay c.j.mckay@clinmed.gla.ac.uk | |
| Institute of Hepatology, University College London | Recruiting |
| London, United Kingdom | |
| Contact: Stephen Pereira stephen.pereira@ucl.ac.uk | |
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: | March 31, 2012 |
| 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 Adenocarcinoma, Mucinous Pancreatitis Pancreatitis, Chronic Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Pancreatic Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013