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

January 26, 2010 updated by: Heidelberg University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden Würtemberg
      • Heidelberg, Baden Würtemberg, Germany, 69120
        • University of Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary success rate of the randomized intervention
Time Frame: Assessed on the day of surgery (day 0)
Assessed on the day of surgery (day 0)

Secondary Outcome Measures

Outcome Measure
Time Frame
Peri-/postoperative complication rate for the randomized intervention
Time Frame: Assessed after 90 day post operation
Assessed after 90 day post operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (ACTUAL)

May 1, 2009

Study Completion (ACTUAL)

May 1, 2009

Study Registration Dates

First Submitted

January 14, 2008

First Submitted That Met QC Criteria

January 24, 2008

First Posted (ESTIMATE)

January 25, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 27, 2010

Last Update Submitted That Met QC Criteria

January 26, 2010

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KSC01/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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