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

NCT ID: NCT00600444

Last Updated: 2010-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-05-31

Brief Summary

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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

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

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

Group Type ACTIVE_COMPARATOR

Venae sectio

Intervention Type PROCEDURE

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

B

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

Group Type EXPERIMENTAL

Punction of V. subclavia

Intervention Type PROCEDURE

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

Interventions

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Venae sectio

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

Intervention Type PROCEDURE

Punction of V. subclavia

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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

Principal Investigators

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Markus W Büchler, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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University of Heidelberg

Heidelberg, Baden Würtemberg, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 21412146 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18950491 (View on PubMed)

Other Identifiers

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KSC01/08

Identifier Type: -

Identifier Source: org_study_id

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