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:
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00991601
First received: October 7, 2009
Last updated: October 12, 2010
Last verified: October 2010
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • patients pain and discomfort at procedure [ Time Frame: immediately ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

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
Study First Received: October 7, 2009
Last Updated: October 12, 2010
Health Authority: Denmark: Ethics Committee

Keywords provided by Herlev Hospital:
liver
pancreas
cancer
tumor
FNAC

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014