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

January 14, 2008
January 26, 2010
February 2008
May 2009   (final data collection date for primary outcome measure)
Primary success rate of the randomized intervention [ Time Frame: Assessed on the day of surgery (day 0) ] [ Designated as safety issue: No ]
Primary success rate of the randomized intervention [ Time Frame: Operation day ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00600444 on ClinicalTrials.gov Archive Site
Peri-/postoperative complication rate for the randomized intervention [ Time Frame: Assessed after 90 day post operation ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
PORTAS 2, Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port
Randomized Controlled Trial Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer
  • Procedure: Venae sectio
    surgical preparation of the cephalic vene to insert a totally implantable access port.
  • Procedure: Punction of V. subclavia
    radiological punction of the v. subclavia with Seldinger technique to implant a totally implantable access port
  • Active Comparator: A
    Venae Sectio technique will be used to insert totally implantable access port (TIAP) by a surgeon
    Intervention: Procedure: Venae sectio
  • Experimental: B
    Punction of Vena Subclavia will be used to insert totally implantable access port (TIAP) by a radiologist.
    Intervention: Procedure: Punction of V. subclavia
Knebel P, Lopez-Benitez R, Fischer L, Radeleff BA, Stampfl U, Bruckner T, Hennes R, Kieser M, Kauczor HU, Büchler MW, Seiler CM. Insertion of totally implantable venous access devices: an expertise-based, randomized, controlled trial (NCT00600444). Ann Surg. 2011 Jun;253(6):1111-7. doi: 10.1097/SLA.0b013e318214ba21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00600444
KSC01/08
No
Prof. Dr. med. M. W. Büchler, Chairman Department of Surgery, University of Heidelberg, Department of General, Visceral and Transplantation Surgery
Heidelberg University
Not Provided
Principal Investigator: Markus W Büchler, Prof. Dr. University of Heidelberg, Department of General, Visceral and Transplantation Surgery
Heidelberg University
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP