Huttner 2015.
Trial name or title | PORTAS‐3 trial |
Methods | ‐Country: Germany
‐Setting: multicentre ‐Study design: RCT |
Participants | ‐Inclusion criteria: Consented oncology adult patients (> 18 years) designated for primary elective TIVAP implantation ‐Exclusion criteria: Patients participating in another interventional trial which could interfere with the primary endpoint |
Interventions | Two implantation methods are compared. The experimental intervention is the surgical cutdown of the cephalic vein. The rescue technique is the modified Seldinger technique where catheter insertion will be supported by use of a guide wire, vein dilator, and peel‐away sheath through the cephalic vein. The control intervention is the Seldinger with percutaneous puncture of the subclavian vein guided by sonography, fluoroscopy, or landmark technique |
Outcomes | ‐Primary success rate ‐Complications: post interventional pneumothorax and haemothorax ‐Duration of port implantation procedure ‐Subjective tolerability of intervention ‐30‐day mortality ‐30‐day morbidity |
Starting date | The PORTAS‐3 trial started recruitment of participants in November 2014. Recruitment is currently ongoing and is expected to be complete in the first quarter of 2016 |
Contact information | phillip.knebel@med.uni‐heidelberg.de |
Notes |
RCT: randomised controlled trial TIVAP: totally implantable venous access ports