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

Purpose

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	Intervention
Cancer	Procedure: Venae sectio Procedure: Punction of V. subclavia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:

Primary success rate of the randomized intervention [ Time Frame: Operation day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Peri-/postoperative complication rate for the randomized intervention [ Time Frame: Assessed after 90 day post operation ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	February 2008
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator 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.
B: Experimental 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

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600444

Contacts


Contact: Phillip Knebel, MD	0049 6221 5639652	phillip.knebel@med.uni-heidelberg.de

Locations


Germany, Baden Würtemberg
	University of Heidelberg	Recruiting
	Heidelberg, Baden Würtemberg, Germany, 69120
	Contact: Phillip Knebel, MD 0049 6221 5639652 phillip.knebel@med.uni-heidelberg.de

Sponsors and Collaborators

University of Heidelberg

Investigators


Principal Investigator:	Markus W Büchler, Prof. Dr.	University of Heidelberg, Department of General, Visceral and Transplantation Surgery

More Information

Responsible Party:	University of Heidelberg, Department of General, Visceral and Transplantation Surgery ( Prof. Dr. med. M. W. Büchler, Chairman Department of Surgery )
Study ID Numbers:	KSC01/08
First Received:	January 14, 2008
Last Updated:	May 22, 2008
ClinicalTrials.gov Identifier:	NCT00600444
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Heidelberg:

permanent venous access

chemotherapy

parenteral nutrition

Patients with a benign and/or malignant diseases which demand a safe and permanent venous access, e.g. for chemotherapy and/or parenteral nutrition

benign diseases

malignant diseases

ClinicalTrials.gov processed this record on October 28, 2008

Sponsored by:	University of Heidelberg
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00600444