PORTAS 2, Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port (PORTAS2)

Heidelberg University

Status: Completed

Conditions: Cancer

Treatments: Procedure: Punction of V. subclavia; Procedure: Venae sectio

Study type: Interventional

Funder types: Other

Identifiers

NCT00600444

KSC01/08

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age equal or greater than 18 years
• Patients scheduled for primary elective implantation of TIAP

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

A

Active Comparator group

Description:

Venae Sectio technique will be used to insert totally implantable access port (TIAP) by a surgeon

Treatment:

Procedure: Venae sectio

B

Experimental group

Description:

Punction of Vena Subclavia will be used to insert totally implantable access port (TIAP) by a radiologist.

Treatment:

Procedure: Punction of V. subclavia