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Ultra Sound Guided Fine Needle Aspiration Cytology (FNAC) of Liver and Pancreas Tumours

This study has suspended participant recruitment.
(New ultra sound technology have made this present study design less relevant and force us to change the design of the study.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00991601
First Posted: October 8, 2009
Last Update Posted: October 13, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Herlev Hospital
  Purpose
Patients with tumors in liver or pancreas are randomized to ultrasound (UL)-guided FNAC biopsies with guidance method or UL-guided FNAC biopsies with free-hand method.

Condition Intervention
Tumors in Liver Tumors in Pancreas Procedure: FNAC (fine needle aspiration cytology)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • quality of obtained biopsy [ Time Frame: one year ]

Secondary Outcome Measures:
  • patients pain and discomfort at procedure [ Time Frame: immediately ]

Estimated Enrollment: 150
Study Start Date: July 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: biopsy arm
patients with tumors in liver and/or pancreas
Procedure: FNAC (fine needle aspiration cytology)
UL guided biopsy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult over 18 years
  • tumors in liver and/or pancreas

Exclusion Criteria:

  • low coagulation factors
  • mentally ill patients.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00991601


Locations
Denmark
Herlev Hospital
DK-2730, Herlev, Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Investigators
Principal Investigator: Jakob Burcharth, MD Herlev Hospital
Study Director: Bjørn Skjoldbye, MD Herlev Hospital
  More Information

Responsible Party: Jakob Burcharth, MD., Herlev Hospital, Department of surgical Gastroenterology
ClinicalTrials.gov Identifier: NCT00991601     History of Changes
Other Study ID Numbers: H-KA-05092
First Submitted: October 7, 2009
First Posted: October 8, 2009
Last Update Posted: October 13, 2010
Last Verified: October 2010

Keywords provided by Herlev Hospital:
liver
pancreas
cancer
tumor
FNAC

Additional relevant MeSH terms:
Neoplasms
Pancrelipase
Pancreatin
Gastrointestinal Agents