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

Tumors in Liver Clinical Trial

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00991601
• Other study ID #: H-KA-05092
• Status: Suspended
• Phase: N/A
• First received: October 7, 2009
• Last updated: October 12, 2010
• Start date: July 2009
• Est. completion date: December 2011

Study information

• Verified date: October 2010
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 150
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult over 18 years

• tumors in liver and/or pancreas

Exclusion Criteria:

• low coagulation factors

• mentally ill patients.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Neoplasms
• Tumors in Liver
• Tumors in Pancreas

Intervention

Procedure:
• FNAC (fine needle aspiration cytology)
UL guided biopsy

Locations

Country	Name	City	State
Denmark	Herlev Hospital	DK-2730, Herlev	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of obtained biopsy		one year	No
Secondary	patients pain and discomfort at procedure		immediately	No