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CompletedNCT00600444PORTAS2Updated Jan 27, 2010

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

An interventional study of Venae sectio and Punction of V. subclavia in Cancer, sponsored by Heidelberg University. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2010-01-27.

Sponsored by Heidelberg University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Sex
All
01

Study 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.

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Conditions studied

  • Cancer

Keywords

  • 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
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In context

Lead sponsor

Heidelberg University is the lead sponsor of 279 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age equal or greater than 18 years
  • Patients scheduled for primary elective implantation of TIAP

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    A

    Venae Sectio technique will be used to insert totally implantable access port (TIAP) by a surgeon

    Procedure: Venae sectio

  • Experimental
    B

    Punction of Vena Subclavia will be used to insert totally implantable access port (TIAP) by a radiologist.

    Procedure: Punction of V. subclavia

Interventions

  • ProcedureVenae sectio

    surgical preparation of the cephalic vene to insert a totally implantable access port.

  • ProcedurePunction of V. subclavia

    radiological punction of the v. subclavia with Seldinger technique to implant a totally implantable access port

06

What researchers measure

Primary outcomes

  1. Primary success rate of the randomized intervention

    Time frame: Assessed on the day of surgery (day 0)

Secondary outcomes

  1. Peri-/postoperative complication rate for the randomized intervention

    Time frame: Assessed after 90 day post operation

07

Study locations

1 site
  • University of Heidelberg
    Heidelberg, Baden Würtemberg 69120, Germany
08

References and documents

Publications

  • Knebel P, Lopez-Benitez R, Fischer L, Radeleff BA, Stampfl U, Bruckner T, Hennes R, Kieser M, Kauczor HU, Buchler 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. PubMed 21412146 ↗
  • Knebel P, Fischer L, Cremonese E, Lopez-Benitez R, Stampfl U, Radeleff B, Kauczor HU, Buchler MW, Seiler CM. Protocol of an expertise based randomized trial comparing surgical Venae Sectio versus radiological puncture of Vena Subclavia for insertion of Totally Implantable Access Port in oncological patients. Trials. 2008 Oct 24;9:60. doi: 10.1186/1745-6215-9-60. PubMed 18950491 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00600444
Lead sponsor
Heidelberg University
First posted
Jan 25, 2008
Start date
Feb 2008
Primary completion
May 2009
Completion
May 2009
Last update
Jan 27, 2010

Study contacts

Markus W Büchler, Prof. Dr.
principal investigator · University of Heidelberg, Department of General, Visceral and Transplantation Surgery

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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