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

Cancer Clinical Trial

— PORTAS2  

Official title:

Randomized Controlled Trial Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00600444
• Other study ID #: KSC01/08
• Status: Completed
• Phase: N/A
• First received: January 14, 2008
• Last updated: January 26, 2010
• Start date: February 2008
• Est. completion date: May 2009

Study information

• Verified date: May 2008
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Procedure:
• Venae sectio
surgical preparation of the cephalic vene to insert a totally implantable access port.
• Punction of V. subclavia
radiological punction of the v. subclavia with Seldinger technique to implant a totally implantable access port

Locations

Country	Name	City	State
Germany	University of Heidelberg	Heidelberg	Baden Würtemberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary success rate of the randomized intervention		Assessed on the day of surgery (day 0)	No
Secondary	Peri-/postoperative complication rate for the randomized intervention		Assessed after 90 day post operation	Yes