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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 14, 2008

Last Updated Date

May 22, 2008

Start Date ^†

February 2008

Current Primary Outcome Measures ^†

Primary success rate of the randomized intervention [ Time Frame: Operation day ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00600444 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Peri-/postoperative complication rate for the randomized intervention [ Time Frame: Assessed after 90 day post operation ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

Randomized Controlled Trial Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port

Brief 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.

Detailed Description

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^†

Cancer

Intervention ^†

Procedure: Venae sectio
Procedure: Punction of V. subclavia

Study Arms / Comparison Groups

Active Comparator: Venae Sectio technique will be used to insert totally implantable access port (TIAP) by a surgeon
Experimental: Punction of Vena Subclavia will be used to insert totally implantable access port (TIAP) by a radiologist.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

100

Estimated Completion Date

August 2008

Estimated Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^††

Contact: Phillip Knebel, MD

0049 6221 5639652

phillip.knebel@med.uni-heidelberg.de

Location Countries ^†

Germany

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00600444

Responsible Party

Prof. Dr. med. M. W. Büchler, Chairman Department of Surgery, University of Heidelberg, Department of General, Visceral and Transplantation Surgery

Secondary IDs ^††

Study Sponsor ^†

University of Heidelberg

Collaborators ^††

Investigators ^†

Principal Investigator:

Markus W Büchler, Prof. Dr.

University of Heidelberg, Department of General, Visceral and Transplantation Surgery

Information Provided By

University of Heidelberg

Verification Date

May 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.