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

This study has been completed.
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00600444
First received: January 14, 2008
Last updated: January 26, 2010
Last verified: May 2008
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Primary success rate of the randomized intervention [ Time Frame: Assessed on the day of surgery (day 0) ] [ 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
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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

Locations
Germany
University of Heidelberg
Heidelberg, Baden Würtemberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Markus W Büchler, Prof. Dr. University of Heidelberg, Department of General, Visceral and Transplantation Surgery
  More Information

No publications provided by Heidelberg University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. med. M. W. Büchler, Chairman Department of Surgery, University of Heidelberg, Department of General, Visceral and Transplantation Surgery
ClinicalTrials.gov Identifier: NCT00600444     History of Changes
Other Study ID Numbers: KSC01/08
Study First Received: January 14, 2008
Last Updated: January 26, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by Heidelberg University:
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 April 17, 2014