CancerPORTAS2NCT00600444
PORTAS 2, Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port
A study testing Venae sectio and Punction of V. subclavia in people with Cancer, run by Heidelberg University at 1 site in Germany.
Trial summary
The purpose of this trial is to investigate if the success rate of punction the vena subclavia (99% in retrospective studies) will be 15% higher than the success rate of venae sectio (80% in retro and prospective studies) for implantation of a totally implantable access ports. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- What is being tested?
- Venae sectio and Punction of V. subclavia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2008to May 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age equal or greater than 18 years
- Patients scheduled for primary elective implantation of TIAP
Who cannot join
- Participation in another clinical trial which could interfere with the primary endpoint of this study
- Lack of compliance
- Impaired mental state or language problem
- Patients with known allergy to contrast agent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port
The purpose of this trial is to investigate if the success rate of punction the vena subclavia (99% in retrospective studies) will be 15% higher than the success rate of venae sectio (80% in retro and prospective studies) for implantation of a totally implantable access ports.
- Conditions
- Cancer
- Being tested
- Venae sectio, Punction of V. subclavia
- Keywords
- permanent venous access, chemotherapy, parenteral nutrition, Patients with a benign and/or malignant diseases which demand a safe and permanent venous access, e.g. for chemotherapy and/or parenteral nutrition, benign diseases, malignant diseases
- Medical subject headings
- Neoplasms, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venae sectioProcedure or surgery
surgical preparation of the cephalic vene to insert a totally implantable access port.
Punction of V. subclaviaProcedure or surgery
radiological punction of the v. subclavia with Seldinger technique to implant a totally implantable access port
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Venae Sectio technique will be used to insert totally implantable access port (TIAP) by a surgeon Receives: Procedure: Venae sectio |
| B | Experimental | Punction of Vena Subclavia will be used to insert totally implantable access port (TIAP) by a radiologist. Receives: Procedure: Punction of V. subclavia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary success rate of the randomized intervention
Measured: Assessed on the day of surgery (day 0)
Secondary outcomes (1)
Peri-/postoperative complication rate for the randomized intervention
Measured: Assessed after 90 day post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Markus W Büchler, Prof. Dr., Principal investigator, University of Heidelberg, Department of General, Visceral and Transplantation Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600444
- Sponsor's protocol ID
- KSC01/08
- Acronym
- PORTAS2
- Status last verified
- May 2008
- First submitted
- 14 Jan 2008
- Last updated
- 27 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Knebel P, Lopez-Benitez R, Fischer L, Radeleff BA, Stampfl U, Bruckner T, Hennes R, Kieser M, Kauczor HU, Buchler MW, Seiler CM. Insertion of totally implantable venous access devices: an expertise-based, randomized, controlled trial (NCT00600444). Ann Surg. 2011 Jun;253(6):1111-7. doi: 10.1097/SLA.0b013e318214ba21.
PubMed 21412146Knebel P, Fischer L, Cremonese E, Lopez-Benitez R, Stampfl U, Radeleff B, Kauczor HU, Buchler MW, Seiler CM. Protocol of an expertise based randomized trial comparing surgical Venae Sectio versus radiological puncture of Vena Subclavia for insertion of Totally Implantable Access Port in oncological patients. Trials. 2008 Oct 24;9:60. doi: 10.1186/1745-6215-9-60.
PubMed 18950491
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port
- ClinicalTrials.gov ID
- NCT00600444
- Acronym / sponsor ID
- PORTAS2 / KSC01/08
- Conditions
- Cancer
- Keywords
- permanent venous access, chemotherapy, parenteral nutrition, Patients with a benign and/or malignant diseases which demand a safe and permanent venous access, e.g. for chemotherapy and/or parenteral nutrition, benign diseases, malignant diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 25 Jan 2008 (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.
The purpose of this trial is to investigate if the success rate of punction the vena subclavia (99% in retrospective studies) will be 15% higher than the success rate of venae sectio (80% in retro and prospective studies) for implantation of a totally implantable access ports.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: Venae sectioVenae Sectio technique will be used to insert totally implantable access port (TIAP) by a surgeon |
| B | Experimental | Procedure: Punction of V. subclaviaPunction of Vena Subclavia will be used to insert totally implantable access port (TIAP) by a radiologist. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age equal or greater than 18 years
- Patients scheduled for primary elective implantation of TIAP
Key exclusion criteria (4 listed)
- Participation in another clinical trial which could interfere with the primary endpoint of this study
- Lack of compliance
- Impaired mental state or language problem
- Patients with known allergy to contrast agent
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 |
|---|---|---|
| Venae sectiosurgical preparation of the cephalic vene to insert a totally implantable access port. | Procedure or surgery | A |
| Punction of V. subclaviaradiological punction of the v. subclavia with Seldinger technique to implant a totally implantable access port | Procedure or surgery | B |
Primary outcome
Primary success rate of the randomized intervention
Time frame: Assessed on the day of surgery (day 0)
1 secondary outcome
Peri-/postoperative complication rate for the randomized intervention
Time frame: Assessed after 90 day post operation
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 27 Jan 2010.
- Derived from this study: PubMed 21412146Knebel P, Lopez-Benitez R, Fischer L, Radeleff BA, Stampfl U, Bruckner T, Hennes R, Kieser M, Kauczor HU, Buchler MW, Seiler CM. Insertion of totally implantable venous access devices: an expertise-based, randomized, controlled trial (NCT00600444). Ann Surg. 2011 Jun;253(6):1111-7. doi: 10.1097/SLA.0b013e318214ba21.
- Derived from this study: PubMed 18950491Knebel P, Fischer L, Cremonese E, Lopez-Benitez R, Stampfl U, Radeleff B, Kauczor HU, Buchler MW, Seiler CM. Protocol of an expertise based randomized trial comparing surgical Venae Sectio versus radiological puncture of Vena Subclavia for insertion of Totally Implantable Access Port in oncological patients. Trials. 2008 Oct 24;9:60. doi: 10.1186/1745-6215-9-60.
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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.
Markus W Büchler, Prof. Dr. principal investigator
University of Heidelberg, Department of General, Visceral and Transplantation Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venae sectio and Punction of V. subclavia in people with Cancer, run by Heidelberg University at 1 site in Germany.
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 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 27 Jan 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 Germany. 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?
Primary success rate of the randomized intervention (time frame: Assessed on the day of surgery (day 0)). 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 NCT00600444, which also lists 2 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 27 Jan 2010.