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Controlled Trial Comparing the Performance of 22 Gauge Versus 25 Gauge EUS-FNA Needles (FNA-22G-25G)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by University Hospital, Gentofte, Copenhagen.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Medicine and Pharmacy Craiova
Allgemeines Krankenhaus Celle, Celle, Germany
Pathologic Institute, Wittinger Strasse, Celle, Germany
Sana Hospital Lübeck GmbH, Lübeck, Germany
Hospital Grosshansdorf, Grosshandorf, Germany
University of Schleswig-Holstein
Information provided by:
University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01016288
First received: November 18, 2009
Last updated: January 18, 2011
Last verified: December 2010
History of Changes
  Purpose

The aim of the study is to compare the performance characteristics of EUS-FNA 22 Gauge needle and EUS FNA 25 Gauge needle in terms of cellularity and diagnostic yield for diagnosis of various pathologies, including lymph nodes, pancreatic, luminal and other lesions outlined by EUS.


Condition
Mediastinal Tumours and Lymph Nodes
Celiac, Perigastric and Peri-pancreatic Lymph Nodes
Pancreatic Masses
Liver Masses
Adrenal Masses

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Multicenter Randomized Controlled Trial Comparing the Performance of 22 Gauge Versus 25 Gauge EUS-FNA Needles

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • Value of EUS-FNA 22 Gauge needle comparing with EUS-FNA 25 Gauge needle in terms of cellularity and diagnostic yield for diagnosis of various pathologies. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Pathology samples obtained through EUS-FNA biopsy processed by paraffin embedding.


Estimated Enrollment: 240
Study Start Date: November 2009
Estimated Study Completion Date: December 2012
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
22 G Needle EUS-FNA
Patients referred for an EUS examination and EUS-FNA of a solid mass lesion adjacent to the upper GI tract using a 22 G needle
25 G Needle EUS-FNA
Patients referred for an EUS examination and EUS-FNA of a solid mass lesion adjacent to the upper GI tract using a 25 G needle

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients referred to one of the participating departments for an EUS examination with EUS-FNA (mediastinal tumours and lymph nodes, celiac, perigastric and peri-pancreatic lymph nodes, pancreatic masses, liver masses, adrenal masses, etc.).

Criteria

Inclusion Criteria:

  • Patients referred for an EUS examination and EUS-FNA of a solid mass lesion adjacent to the upper GI tract
  • Well informed signed consent for EUS-guided FNA

Exclusion Criteria:

  • Severe coagulopathy
  • Uncorrectable severe platelet dysfunction
  • Presence of large intervening vessels on color or power Doppler
  • Failure to provide informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01016288

Contacts
Contact: Peter Vilmann, Professor +4539777950 pevi@geh.regionh.dk
Contact: Adrian Saftoiu, Professor +40744823355 adriansaftoiu@aim.com

Locations
Denmark
Endoscopy Z-806, Gentofte, Department of Surgical Gastroenterology, Gentofte and Herlev Hospitals Recruiting
Copenhagen, Denmark
Contact: Peter Vilmann, Professor         pevi@geh.regionh.dk    
Contact: Hazem Hassan, MD            
Department of Pathology, Herlev University Hospital, Hellerup Active, not recruiting
Copenhagen, Denmark
Germany
Klinik für Gastroenterologie/GI-Onkologie, Allgemeines Krankenhaus Celle Recruiting
Celle, Germany
Contact: Stephan Hollerbach, MD            
Contact: Paul Clementsen, MD            
Department of Medicine, GI Division, Allgemeines Krankenhaus MD Recruiting
Celle, Germany
Contact: Ulrich Freund, MD            
Pathologic Institute, Wittinger Strasse Active, not recruiting
Celle, Germany
Cytological Laboratory, Hospital Grosshansdorf - Center for Pneumology and Thoracic Surgery Active, not recruiting
Großhansdorf, Germany
Department of Pathology, Medical University Schleswig-Holstein Active, not recruiting
Luebeck, Germany
Department of Internal Medicine, Sana Hospital Lübeck GmbHg, MD Recruiting
Lübeck, Germany
Contact: T Noll, MD            
Romania
Research Center of Gastroenterology and Hepatology, University of Medicine and Pharmacy Recruiting
Craiova, Romania
Contact: Adrian Saftoiu, Professor     +40744823355     adriansaftoiu@aim.com    
Contact: Dan Ionut Gheonea, MD     +40751268731     digheonea@gmail.com    
Sub-Investigator: Florin Gorunescu, Professor            
Sub-Investigator: Carmen Popescu, MD            
Sub-Investigator: Ana-Maria Ioncica, MD            
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
University of Medicine and Pharmacy Craiova
Allgemeines Krankenhaus Celle, Celle, Germany
Pathologic Institute, Wittinger Strasse, Celle, Germany
Sana Hospital Lübeck GmbH, Lübeck, Germany
Hospital Grosshansdorf, Grosshandorf, Germany
University of Schleswig-Holstein
Investigators
Study Director: Peter Vilmann, Professor Gentofte Hospital, Copenhagen University, Denmark
  More Information

Publications:

Responsible Party: Peter Vilmann, Department of Surgical Gastroenterology, Gentofte and Herlev Hospitals, Copenhagen University, Denmark
ClinicalTrials.gov Identifier: NCT01016288     History of Changes
Other Study ID Numbers: EUS-FNA-DK-PV-2009
Study First Received: November 18, 2009
Last Updated: January 18, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University Hospital, Gentofte, Copenhagen:
EUS-FNA
22 Gauge Needle
25 Gauge Needle

Additional relevant MeSH terms:
Mediastinal Diseases
Mediastinal Neoplasms
Marfan Syndrome
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Thoracic Diseases
Respiratory Tract Diseases
Bone Diseases, Developmental
Bone Diseases
 Musculoskeletal Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 22, 2013