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

NCT01315548 | Completed DMC

• 2 other identifiers: CEH-EUS-001CEH-EUS-UMFCV-RO
• Study Type: observational
• Target: 210
• Locations: 8 countries
• Sites: 14

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.

Conditions

Adenocarcinoma Pancreas; Chronic Pancreatitis

Keywords

Contrast enhanced harmonic endoscopic ultrasound; Pancreatic adenocarcinoma; Chronic pancreatitis

Outcome Measures

Primary Outcomes (1)

• Contrast enhanced harmonic endoscopic ultrasound

  Value of contrast enhanced harmonic endoscopic ultrasound for the differential diagnoses of pancreatic masses.

  Every six months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 90 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 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

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
• Copenhagen University Hospital, Denmark: collaborator
• Caritas-Krankenhaus Bad Mergentheim: collaborator
• Institut Paoli-Calmettes: collaborator
• University of Witten/Herdecke: collaborator
• Hospital Meiningen Germany: collaborator
• Odense University Hospital: collaborator
• University of Santiago de Compostela: collaborator
• Università Vita-Salute San Raffaele: collaborator
• SRH Wald-Klinikum Gera GmbH: collaborator
• University of Bergen: collaborator
• Institutul Clinic Fundeni: collaborator
• Glasgow Royal Infirmary: collaborator
• University College, London: collaborator

Study Sites (14)

Department of Surgical Gastroenterology, Gentofte & Herlev Hospital, University of Copenhagen

Copenhagen, Denmark

Location

Center for Surgical Ultrasound, Department of Surgery, Odense University Hospital

Odense, Denmark

Location

Paoli-Calmettes Institut

Marseille, France

Location

Caritas-Krankenhaus Bad Mergentheim

Bad Mergentheim, Germany

Location

SRH Wald-Klinikum

Gera, Germany

Location

Department of Internal Medicine II, Hospital Meiningen

Meiningen, Germany

Location

Helios Klinikum, University of Witten/Herdecke

Wuppertal, Germany

Location

Gastroenterology and Gastrointestinal Endoscopy Unit, Vita Salute San Raffaele University

Milan, Italy

Location

Insitute of Medicine, University of Bergen and National Centre for Ultrasound in Gastroenterology, Haukeland University Hospital

Bergen, Norway

Location

Center of Gastroenterology and Hepatology, Fundeni Clinical Institute

Bucharest, Romania

Location

Gastroenterology Department, University of Medicine and Pharmacy

Craiova, Romania

Location

University Hospital, Santiago de Compostela

Santiago de Compostela, Spain

Location

Hepatobiliary Surgery, Glasgow Royal Infirmary

Glasgow, United Kingdom

Location

Institute of Hepatology, University College London

London, United Kingdom

Location

Related Publications (8)

• Claudon M, Cosgrove D, Albrecht T, Bolondi L, Bosio M, Calliada F, Correas JM, Darge K, Dietrich C, D'Onofrio M, Evans DH, Filice C, Greiner L, Jager K, Jong Nd, Leen E, Lencioni R, Lindsell D, Martegani A, Meairs S, Nolsoe C, Piscaglia F, Ricci P, Seidel G, Skjoldbye B, Solbiati L, Thorelius L, Tranquart F, Weskott HP, Whittingham T. Guidelines and good clinical practice recommendations for contrast enhanced ultrasound (CEUS) - update 2008. Ultraschall Med. 2008 Feb;29(1):28-44. doi: 10.1055/s-2007-963785. No abstract available.

  PMID: 18270887 BACKGROUND

• Seicean A, Badea R, Stan-Iuga R, Gulei I, Pop T, Pascu O. The added value of real-time harmonics contrast-enhanced endoscopic ultrasonography for the characterisation of pancreatic diseases in routine practice. J Gastrointestin Liver Dis. 2010 Mar;19(1):99-104.

  PMID: 20361085 BACKGROUND

• Hocke M, Schulze E, Gottschalk P, Topalidis T, Dietrich CF. Contrast-enhanced endoscopic ultrasound in discrimination between focal pancreatitis and pancreatic cancer. World J Gastroenterol. 2006 Jan 14;12(2):246-50. doi: 10.3748/wjg.v12.i2.246.

  PMID: 16482625 BACKGROUND

• Saftoiu A, Iordache SA, Gheonea DI, Popescu C, Malos A, Gorunescu F, Ciurea T, Iordache A, Popescu GL, Manea CT. Combined contrast-enhanced power Doppler and real-time sonoelastography performed during EUS, used in the differential diagnosis of focal pancreatic masses (with videos). Gastrointest Endosc. 2010 Oct;72(4):739-47. doi: 10.1016/j.gie.2010.02.056. Epub 2010 Aug 2.

  PMID: 20674916 BACKGROUND

• Seicean A. Endoscopic ultrasound in chronic pancreatitis: where are we now? World J Gastroenterol. 2010 Sep 14;16(34):4253-63. doi: 10.3748/wjg.v16.i34.4253.

  PMID: 20818808 BACKGROUND

• Dietrich CF, Ignee A, Frey H. Contrast-enhanced endoscopic ultrasound with low mechanical index: a new technique. Z Gastroenterol. 2005 Nov;43(11):1219-23. doi: 10.1055/s-2005-858662.

  PMID: 16267707 BACKGROUND

• Seicean A, Badea R, Stan-Iuga R, Mocan T, Gulei I, Pascu O. Quantitative contrast-enhanced harmonic endoscopic ultrasonography for the discrimination of solid pancreatic masses. Ultraschall Med. 2010 Dec;31(6):571-6. doi: 10.1055/s-0029-1245833. Epub 2010 Nov 15.

  PMID: 21080306 BACKGROUND

• Saftoiu A, Vilmann P, Dietrich CF, Iglesias-Garcia J, Hocke M, Seicean A, Ignee A, Hassan H, Streba CT, Ioncica AM, Gheonea DI, Ciurea T. Quantitative contrast-enhanced harmonic EUS in differential diagnosis of focal pancreatic masses (with videos). Gastrointest Endosc. 2015 Jul;82(1):59-69. doi: 10.1016/j.gie.2014.11.040. Epub 2015 Mar 16.

  PMID: 25792386 DERIVED

Related Links

• Related Info

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

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 Săftoiu, 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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2011
• First Posted: March 15, 2011
• Study Start: March 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 17, 2018

Record last verified: 2018-01

Locations

GB (2); DE (4); FR (1); DK (2); ES (1); NO (1); RO (2); IT (1)