Ultra Sound Guided Fine Needle Aspiration Cytology (FNAC)... | NCT00991601

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

NCT00991601

Sponsor

Herlev Hospital

Status

Suspended

Last Update Posted

Oct 13, 2010Estimated

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Tumors in Liver
Tumors in Pancreas

Interventions

FNAC (fine needle aspiration cytology)

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

New ultra sound technology have made this present study design less relevant and force us to change the design of the study.

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Sep 2011Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Oct 7, 2009

First Submission Date that Met QC Criteria

Oct 7, 2009

First Posted Date

Oct 8, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2010

Last Update Posted Date

Oct 13, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
biopsy arm	Experimental	patients with tumors in liver and/or pancreas	Procedure: FNAC (fine needle aspiration cytology)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FNAC (fine needle aspiration cytology)	Procedure	UL guided biopsy	biopsy arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
quality of obtained biopsy		one year

Secondary Outcomes

Measure	Description	Time Frame
patients pain and discomfort at procedure		immediately

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult over 18 years
tumors in liver and/or pancreas

Exclusion Criteria:

low coagulation factors
mentally ill patients.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jakob Burcharth, MD	Herlev Hospital	Principal Investigator
Bjørn Skjoldbye, MD	Herlev Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Herlev Hospital		Dk-2730, Herlev	Herlev	2730	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided