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

This study has been completed.
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 (Responsible Party):
Peter Vilmann, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01016288
First received: November 18, 2009
Last updated: April 7, 2014
Last verified: April 2014
  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:


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.


Enrollment: 135
Study Start Date: November 2009
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01016288

Locations
Denmark
Department of Pathology, Herlev University Hospital, Hellerup
Copenhagen, Denmark
Endoscopy Z-806, Gentofte, Department of Surgical Gastroenterology, Gentofte and Herlev Hospitals
Copenhagen, Denmark
Germany
Klinik für Gastroenterologie/GI-Onkologie, Allgemeines Krankenhaus Celle
Celle, Germany
Pathologic Institute, Wittinger Strasse
Celle, Germany
Department of Medicine, GI Division, Allgemeines Krankenhaus MD
Celle, Germany
Cytological Laboratory, Hospital Grosshansdorf - Center for Pneumology and Thoracic Surgery
Großhansdorf, Germany
Department of Pathology, Medical University Schleswig-Holstein
Luebeck, Germany
Department of Internal Medicine, Sana Hospital Lübeck GmbHg, MD
Lübeck, Germany
Romania
Research Center of Gastroenterology and Hepatology, University of Medicine and Pharmacy
Craiova, Romania
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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Vilmann, Professor, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01016288     History of Changes
Other Study ID Numbers: EUS-FNA-DK-PV-2009
Study First Received: November 18, 2009
Last Updated: April 7, 2014
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 Neoplasms
Mediastinal Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Thoracic Diseases
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014