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

Sponsor

Heidelberg University (Other)

Overall Status

Completed

CT.gov ID

NCT00600444

Collaborator

(none)

100

Enrollment

Location

Arms

14.9

Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Procedure: Venae sectio Procedure: Punction of V. subclavia	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

May 1, 2009

Actual Study Completion Date :

May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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.
Experimental: B 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

Arm

Intervention/Treatment

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.

Experimental: B

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

Outcome Measures

Primary Outcome Measures

Primary success rate of the randomized intervention [Assessed on the day of surgery (day 0)]

Secondary Outcome Measures

Peri-/postoperative complication rate for the randomized intervention [Assessed after 90 day post operation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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