PORTAS 2, Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port
NCT ID: NCT00600444
Last Updated: 2010-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2008-02-29
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Venae Sectio technique will be used to insert totally implantable access port (TIAP) by a surgeon
Venae sectio
surgical preparation of the cephalic vene to insert a totally implantable access port.
B
Punction of Vena Subclavia will be used to insert totally implantable access port (TIAP) by a radiologist.
Punction of V. subclavia
radiological punction of the v. subclavia with Seldinger technique to implant a totally implantable access port
Interventions
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Venae sectio
surgical preparation of the cephalic vene to insert a totally implantable access port.
Punction of V. subclavia
radiological punction of the v. subclavia with Seldinger technique to implant a totally implantable access port
Eligibility Criteria
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Inclusion Criteria
* Patients scheduled for primary elective implantation of TIAP
Exclusion Criteria
* Lack of compliance
* Impaired mental state or language problem
* Patients with known allergy to contrast agent
ALL
No
Sponsors
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Heidelberg University
OTHER
Responsible Party
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University of Heidelberg, Department of General, Visceral and Transplantation Surgery
Principal Investigators
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Markus W Büchler, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Heidelberg, Department of General, Visceral and Transplantation Surgery
Locations
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University of Heidelberg
Heidelberg, Baden Würtemberg, Germany
Countries
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References
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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.
Knebel 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.
Other Identifiers
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KSC01/08
Identifier Type: -
Identifier Source: org_study_id
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