Endoscopic Ultrasound Elastography in Pancreatic Masses

NCT00909103 | Completed DMC

• 2 other identifiers: EUS-EG001EUS-EG-UMFCV-RO
• Study Type: observational
• Target: 285
• Locations: 10 countries
• Sites: 18

Brief Summary

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.

Conditions

Pancreatic Adenocarcinoma; Chronic Pancreatitis

Keywords

Endoscopic Ultrasound Elastography; Pancreatic adenocarcinoma; Chronic Pancreatitis

Outcome Measures

Primary Outcomes (1)

• Value of endoscopic ultrasound elastography for the differential diagnoses of pancreatic masses.

  18 months

Study Arms (2)

Pancreatic adenocarcinoma

Patients diagnosed with solid pancreatic adenocarcinoma masses, with cytological / histological confirmation

Chronic pancreatitis

Patients diagnosed with solid pancreatic tumor masses with all the criteria fulfilled to exclude pancreatic cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (18)

Erasme University

Brussels, Belgium

Location

Universite Chatolique Louvain

Brussels, Belgium

Location

Gentofte University Hospital

Copenhagen, Denmark

Location

University Hospital

Odense, Denmark

Location

Institute Paoli Calmettes

Marseille, France

Location

Caritas-Krankenhaus

Bad Mergentheim, Germany

Location

St. Josef Hospital

Bochum, Germany

Location

SRH Klinik

Gera, Germany

Location

University Clinic Mainz

Mainz, Germany

Location

Dr.Horst-Schmidt-Klinik

Wiesbaden, Germany

Location

HELIOS Klinikum Wuppertal, University of Witten/Herdecke

Wuppertal, Germany

Location

Hospital San Raffaele

Milan, Italy

Location

Erasme Medisch Centrum

Rotterdam, Netherlands

Location

University of Haukeland

Bergen, Norway

Location

University of Medicine and Pharmacy Craiova

Craiova, Romania

Location

University Hospital Santiago

Santiago, Spain

Location

Glasgow Royal Infirmary

Glasgow, United Kingdom

Location

Newcastle Upon Tyne Hospitals

Newcastle, United Kingdom

Location

Related Publications (9)

• Frey H. [Realtime elastography. A new ultrasound procedure for the reconstruction of tissue elasticity]. Radiologe. 2003 Oct;43(10):850-5. doi: 10.1007/s00117-003-0943-2. German.

  PMID: 14605701 BACKGROUND

• Ophir J, Alam SK, Garra B, Kallel F, Konofagou E, Krouskop T, Varghese T. Elastography: ultrasonic estimation and imaging of the elastic properties of tissues. Proc Inst Mech Eng H. 1999;213(3):203-33. doi: 10.1243/0954411991534933.

  PMID: 10420776 BACKGROUND

• Itoh A, Ueno E, Tohno E, Kamma H, Takahashi H, Shiina T, Yamakawa M, Matsumura T. Breast disease: clinical application of US elastography for diagnosis. Radiology. 2006 May;239(2):341-50. doi: 10.1148/radiol.2391041676. Epub 2006 Feb 16.

  PMID: 16484352 BACKGROUND

• Miyanaga N, Akaza H, Yamakawa M, Oikawa T, Sekido N, Hinotsu S, Kawai K, Shimazui T, Shiina T. Tissue elasticity imaging for diagnosis of prostate cancer: a preliminary report. Int J Urol. 2006 Dec;13(12):1514-8. doi: 10.1111/j.1442-2042.2006.01612.x.

  PMID: 17118027 BACKGROUND

• Rago T, Santini F, Scutari M, Pinchera A, Vitti P. Elastography: new developments in ultrasound for predicting malignancy in thyroid nodules. J Clin Endocrinol Metab. 2007 Aug;92(8):2917-22. doi: 10.1210/jc.2007-0641. Epub 2007 May 29.

  PMID: 17535993 BACKGROUND

• Janssen J, Schlorer E, Greiner L. EUS elastography of the pancreas: feasibility and pattern description of the normal pancreas, chronic pancreatitis, and focal pancreatic lesions. Gastrointest Endosc. 2007 Jun;65(7):971-8. doi: 10.1016/j.gie.2006.12.057.

  PMID: 17531630 BACKGROUND

• Saftoiu A, Vilmann P, Ciurea T, Popescu GL, Iordache A, Hassan H, Gorunescu F, Iordache S. Dynamic analysis of EUS used for the differentiation of benign and malignant lymph nodes. Gastrointest Endosc. 2007 Aug;66(2):291-300. doi: 10.1016/j.gie.2006.12.039.

  PMID: 17643702 BACKGROUND

• Saftoiu A, Vilmann P, Gorunescu F, Janssen J, Hocke M, Larsen M, Iglesias-Garcia J, Arcidiacono P, Will U, Giovannini M, Dietrich CF, Havre R, Gheorghe C, McKay C, Gheonea DI, Ciurea T; European EUS Elastography Multicentric Study Group. Efficacy of an artificial neural network-based approach to endoscopic ultrasound elastography in diagnosis of focal pancreatic masses. Clin Gastroenterol Hepatol. 2012 Jan;10(1):84-90.e1. doi: 10.1016/j.cgh.2011.09.014. Epub 2011 Oct 1.

  PMID: 21963957 DERIVED

• Saftoiu A, Vilmann P, Gorunescu F, Janssen J, Hocke M, Larsen M, Iglesias-Garcia J, Arcidiacono P, Will U, Giovannini M, Dietrich C, Havre R, Gheorghe C, McKay C, Gheonea DI, Ciurea T; European EUS Elastography Multicentric Study Group. Accuracy of endoscopic ultrasound elastography used for differential diagnosis of focal pancreatic masses: a multicenter study. Endoscopy. 2011 Jul;43(7):596-603. doi: 10.1055/s-0030-1256314. Epub 2011 Mar 24.

  PMID: 21437851 DERIVED

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITHOUT 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

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adrian Saftoiu, Professor

  University of Medicine and Pharmacy Craiova, Romania

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 25, 2009
• First Posted: May 27, 2009
• Study Start: June 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 12, 2010

Record last verified: 2010-01

Locations

DE (6); NO (1); BE (2); ES (1); DK (2); GB (2); FR (1); IT (1); NL (1); RO (1)