Tumors in LiverNCT00991601
Ultra Sound Guided Fine Needle Aspiration Cytology (FNAC) of Liver and Pancreas Tumours
A study testing FNAC (fine needle aspiration cytology) in people with Tumors in Liver and Tumors in Pancreas, run by Herlev Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors in Liver, Tumors in Pancreas
- What is being tested?
- FNAC (fine needle aspiration cytology)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult over 18 years
- tumors in liver and/or pancreas
Who cannot join
- low coagulation factors
- mentally ill patients.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Tumors in Liver, Tumors in Pancreas
- Being tested
- FNAC (fine needle aspiration cytology)
- Keywords
- liver, pancreas, cancer, tumor, FNAC
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FNAC (fine needle aspiration cytology)Procedure or surgery
UL guided biopsy
| Study group | Role | What they receive |
|---|---|---|
| biopsy arm | Experimental | patients with tumors in liver and/or pancreas Receives: Procedure: FNAC (fine needle aspiration cytology) |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of obtained biopsy
Measured: one year
Secondary outcomes (1)
patients pain and discomfort at procedure
Measured: immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2009 (estimated)
- Study startJul 2009
- Primary completionSep 2011 (estimated)
- Study completionDec 2011 (estimated)
Why it stopped: New ultra sound technology have made this present study design less relevant and force us to change the design of the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumors in LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jakob Burcharth, MD, Principal investigator, Herlev HospitalBjørn Skjoldbye, MD, Study director, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991601
- Sponsor's protocol ID
- H-KA-05092
- Status last verified
- Oct 2010
- First submitted
- 7 Oct 2009
- Last updated
- 13 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra Sound Guided Fine Needle Aspiration Cytology (FNAC) of Liver and Pancreas Tumours
- ClinicalTrials.gov ID
- NCT00991601
- Acronym / sponsor ID
- H-KA-05092
- Conditions
- Tumors in Liver, Tumors in Pancreas
- Keywords
- liver, pancreas, cancer, tumor, FNAC
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: New ultra sound technology have made this present study design less relevant and force us to change the design of the study.
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 8 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| biopsy arm | Experimental | Procedure: FNAC (fine needle aspiration cytology)patients with tumors in liver and/or pancreas |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult over 18 years
- tumors in liver and/or pancreas
Key exclusion criteria (2 listed)
- low coagulation factors
- mentally ill patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FNAC (fine needle aspiration cytology)UL guided biopsy | Procedure or surgery | biopsy arm |
Primary outcome
quality of obtained biopsy
Time frame: one year
1 secondary outcome
patients pain and discomfort at procedure
Time frame: immediately
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jakob Burcharth, MD principal investigator
Herlev Hospital
Bjørn Skjoldbye, MD study director
Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FNAC (fine needle aspiration cytology) in people with Tumors in Liver and Tumors in Pancreas, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 13 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of obtained biopsy (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2010.