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

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Procedure: Venae sectio; Procedure: Punction of V. subclavia

• Registration Number: NCT00600444
• Lead Sponsor: Heidelberg University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-01-14
• Study First Submitted QC: 2008-01-24
• Study First Posted: 2008-01-25
• Study Start: 2008-02
• Status Verified: 2008-05
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Last Update Submitted: 2010-01-26
• Last Update Posted: 2010-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Venae sectio	Venae Sectio technique will be used to insert totally implantable access port (TIAP) by a surgeon
B	Punction of V. subclavia	Punction of Vena Subclavia will be used to insert totally implantable access port (TIAP) by a radiologist.

Primary Outcome Measures

Name	Time	Method
Primary success rate of the randomized intervention	Assessed on the day of surgery (day 0)

Secondary Outcome Measures

Name	Time	Method
Peri-/postoperative complication rate for the randomized intervention	Assessed after 90 day post operation

Trial Locations

Locations (1)

University of Heidelberg; 🇩🇪 Heidelberg, Baden Würtemberg, Germany