PORTAS 2, Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port (PORTAS2)
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:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Controlled Trial Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port|
- Primary success rate of the randomized intervention [ Time Frame: Assessed on the day of surgery (day 0) ] [ Designated as safety issue: No ]
- Peri-/postoperative complication rate for the randomized intervention [ Time Frame: Assessed after 90 day post operation ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2008|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Active Comparator: A
Venae Sectio technique will be used to insert totally implantable access port (TIAP) by a surgeon
Procedure: Venae sectio
surgical preparation of the cephalic vene to insert a totally implantable access port.
Punction of Vena Subclavia will be used to insert totally implantable access port (TIAP) by a radiologist.
Procedure: Punction of V. subclavia
radiological punction of the v. subclavia with Seldinger technique to implant a totally implantable access port
|University of Heidelberg|
|Heidelberg, Baden Würtemberg, Germany, 69120|
|Principal Investigator:||Markus W Büchler, Prof. Dr.||University of Heidelberg, Department of General, Visceral and Transplantation Surgery|