Focus of StudyNCT01971021
Vascular Access in Cancer Patients - PICC vs PORT in a Randomized Controlled Trial.
A study testing PICC or subcutaneous venous port in people with Focus of Study, run by Linkoeping University at 1 site in Sweden.
Trial summary
As of today there is very limited scientific knowledge in whicj of the two vascular access devices (PICC-line or venous ports) that offers the lowest complicationrates in cancerpatients. The study group wants to clearify this unsolved matter by comparing the two systems. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Focus of Study
- What is being tested?
- PICC or subcutaneous venous port
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2013to 29 Jan 2018
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cancer treatment with need for central venous access
- Age >18 yrs
- Suspected survival > 4 weeks
- Need of central venous access >4 weeks
Who cannot join
- Ongoing uncontrolled systemic infection
- Prescence of significant thrombosis/stenosis in arm or central veins
- Unability to communicate
- Probable upcoming need for dialysis fistula
Trial locations and contacts
1 site in 1 country.
About this study
As of today there is very limited scientific knowledge in whicj of the two vascular access devices (PICC-line or venous ports) that offers the lowest complicationrates in cancerpatients. The study group wants to clearify this unsolved matter by comparing the two systems. Our primary endpoint is the presens of catheter related venous thrombosis. We are also looking at all catheter related complications and patient satisfaction.
- Conditions
- Focus of Study
- Being tested
- PICC or subcutaneous venous port
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICC or subcutaneous venous portDevice
| Study group | Role | What they receive |
|---|---|---|
| PICC-line | Active comparator | PICC line insertion. Receives: Device: PICC or subcutaneous venous port |
| PORT | Active comparator | Subcutaneous venous port insertion Receives: Device: PICC or subcutaneous venous port |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurence of catheter related venous thrombosis
regular follow-ups at month 1, 3, 6 and 12.
Measured: Upon clinical suspiscion during the one the patient i enrolled in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study startApr 2013
- Primary completion29 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Focus of StudyStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open label pragmatic
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Ryhov County Hospital
- Responsible party
- Principal investigator, Knut Taxbro, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971021
- Sponsor's protocol ID
- EPN Linkoping 2013/56-31
- Status last verified
- Jan 2018
- First submitted
- 24 Sep 2013
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Utas A, Seifert S, Taxbro K. Peripherally inserted central catheters versus implanted port catheters in patients with breast cancer: a post hoc analysis of the PICCPORT randomised controlled trial. BJA Open. 2025 Feb 4;13:100377. doi: 10.1016/j.bjao.2025.100377. eCollection 2025 Mar.
PubMed 39991709Taxbro K, Hammarskjold F, Juhlin D, Hagman H, Bernfort L, Berg S. Cost analysis comparison between peripherally inserted central catheters and implanted chest ports in patients with cancer-A health economic evaluation of the PICCPORT trial. Acta Anaesthesiol Scand. 2020 Mar;64(3):385-393. doi: 10.1111/aas.13505. Epub 2019 Nov 27.
PubMed 31721153Taxbro K, Hammarskjold F, Thelin B, Lewin F, Hagman H, Hanberger H, Berg S. Clinical impact of peripherally inserted central catheters vs implanted port catheters in patients with cancer: an open-label, randomised, two-centre trial. Br J Anaesth. 2019 Jun;122(6):734-741. doi: 10.1016/j.bja.2019.01.038. Epub 2019 Apr 17.
PubMed 31005243
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Access in Cancer Patients - PICC vs PORT in a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01971021
- Acronym / sponsor ID
- EPN Linkoping 2013/56-31
- Conditions
- Focus of Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Ryhov County Hospital
- Study start
- Apr 2013 (actual)
- Primary completion
- 29 Jan 2018 (actual)
- First posted
- 28 Oct 2013 (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.
As of today there is very limited scientific knowledge in whicj of the two vascular access devices (PICC-line or venous ports) that offers the lowest complicationrates in cancerpatients. The study group wants to clearify this unsolved matter by comparing the two systems. Our primary endpoint is the presens of catheter related venous thrombosis. We are also looking at all catheter related complications and patient satisfaction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- open label pragmatic
| Arm | Type | Receives |
|---|---|---|
| PICC-line | Active comparator | Device: PICC or subcutaneous venous portPICC line insertion. |
| PORT | Active comparator | Device: PICC or subcutaneous venous portSubcutaneous venous port insertion |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- cancer treatment with need for central venous access
- Age >18 yrs
- Suspected survival > 4 weeks
- Need of central venous access >4 weeks
Key exclusion criteria (4 listed)
- Ongoing uncontrolled systemic infection
- Prescence of significant thrombosis/stenosis in arm or central veins
- Unability to communicate
- Probable upcoming need for dialysis fistula
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 |
|---|---|---|
| PICC or subcutaneous venous port | Device | PICC-line, PORT |
Primary outcome
The occurence of catheter related venous thrombosis
Time frame: Upon clinical suspiscion during the one the patient i enrolled in the study
regular follow-ups at month 1, 3, 6 and 12.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- Derived from this study: PubMed 39991709Utas A, Seifert S, Taxbro K. Peripherally inserted central catheters versus implanted port catheters in patients with breast cancer: a post hoc analysis of the PICCPORT randomised controlled trial. BJA Open. 2025 Feb 4;13:100377. doi: 10.1016/j.bjao.2025.100377. eCollection 2025 Mar.
- Derived from this study: PubMed 31721153Taxbro K, Hammarskjold F, Juhlin D, Hagman H, Bernfort L, Berg S. Cost analysis comparison between peripherally inserted central catheters and implanted chest ports in patients with cancer-A health economic evaluation of the PICCPORT trial. Acta Anaesthesiol Scand. 2020 Mar;64(3):385-393. doi: 10.1111/aas.13505. Epub 2019 Nov 27.
- Derived from this study: PubMed 31005243Taxbro K, Hammarskjold F, Thelin B, Lewin F, Hagman H, Hanberger H, Berg S. Clinical impact of peripherally inserted central catheters vs implanted port catheters in patients with cancer: an open-label, randomised, two-centre trial. Br J Anaesth. 2019 Jun;122(6):734-741. doi: 10.1016/j.bja.2019.01.038. Epub 2019 Apr 17.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PICC or subcutaneous venous port in people with Focus of Study, run by Linkoeping University at 1 site in Sweden.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 30 Jan 2018. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The occurence of catheter related venous thrombosis (time frame: Upon clinical suspiscion during the one the patient i enrolled in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01971021, which also lists 3 linked publications.
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 30 Jan 2018.