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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014