Ultrasound-guided Subclavian Vein Puncture Versus Cephalic Vein Dissection for Venous Access Port Implantation

This study is not yet open for participant recruitment.

Verified May 2012 by University of Lausanne Hospitals

Sponsor:

Information provided by (Responsible Party):

Nicolas DEMARTINES, University of Lausanne Hospitals

ClinicalTrials.gov Identifier:

NCT01584193

First received: April 21, 2012

Last updated: May 7, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 21, 2012

Last Updated Date

May 7, 2012

Start Date ^ICMJE

May 2012

Estimated Primary Completion Date

February 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

surgical procedure time [ Time Frame: during surgical procedure ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01584193 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

primary implementation success rate [ Time Frame: during surgical procedure ] [ Designated as safety issue: No ]
overall implementation success rate [ Time Frame: during surgical procedure ] [ Designated as safety issue: No ]
technique conversion rate and causes [ Time Frame: during surgical procedure ] [ Designated as safety issue: No ]
pain during surgical procedure [ Time Frame: during surgical procedure ] [ Designated as safety issue: No ]
pain at 5 days [ Time Frame: 5 days post-procedure ] [ Designated as safety issue: No ]
Pain at 30 days [ Time Frame: 30 days post-procedure ] [ Designated as safety issue: No ]
Complications rate during surgical procedure [ Time Frame: during surgical procedure ] [ Designated as safety issue: Yes ]
catheter malposition, hemorrhage, hemotoma, hemothorax, pneumothorax
Complications rate at 5 days [ Time Frame: 5 days post-procedure ] [ Designated as safety issue: Yes ]
hematoma, infection, symptomatic venous thrombosis, pneumothorax
Complications rate at 30 days [ Time Frame: 30 days post-procedure ] [ Designated as safety issue: Yes ]
infection, symptomatic venous thrombosis, pneumothorax, venous access port dysfunction

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Ultrasound-guided Subclavian Vein Puncture Versus Cephalic Vein Dissection for Venous Access Port Implantation

Official Title ^ICMJE

Ultrasound-guided Subclavian Vein Puncture Versus Cephalic Vein Dissection for Totally Implantable Venous Access Port Implementation: a Single-center Controlled Randomized Superiority Trial

Brief Summary

The purpose of this study is to compare two different surgical techniques for implementation of totally implantable central venous access ports. Ultrasound-guided suclavian vein puncture is compared to cephalic vein dissection.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Vascular Surgical Procedures

Intervention ^ICMJE

Procedure: Ultrasound-guided subclavian vein puncture
Central venous access port implementation through ultrasound-guided subclavian vein puncture and Seldinger technique
Other Names:
- US-guided
- Seldinger technique
Procedure: Cephalic vein dissection
Central venous access port implementation through cephalic vein dissection and cutdown

Other Name: Venous cutdown

Study Arm (s)

Experimental: US-guided subclavian vein puncture
Intervention: Procedure: Ultrasound-guided subclavian vein puncture
Active Comparator: Cephalic vein dissection
Intervention: Procedure: Cephalic vein dissection

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

172

Completion Date

Not Provided

Estimated Primary Completion Date

February 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age > 18
Informed consent
Need for central venous access port implementation under local anesthesia

Exclusion Criteria:

Impaired blood clotting
Ongoing antiplatelet drugs therapy, except acetylsalicylic acid
Trauma or surgical past history on both shoulder girdles
Known central venous thrombosis (subclavian vein, upper vena cava)
Known pneumothorax
Septic state
Agranulocytosis

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Marc Dufour	+41795567489	Marc.Dufour@chuv.ch
Contact: Martin Hubner	+41795561506	Martin.Hubner@chuv.ch

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT Number ^ICMJE

NCT01584193

Other Study ID Numbers ^ICMJE

CHV 46/11

Has Data Monitoring Committee

Responsible Party

Nicolas DEMARTINES, University of Lausanne Hospitals

Study Sponsor ^ICMJE

University of Lausanne Hospitals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Nicolas Demartines

University Hospital Lausanne, Department of Visceral Surgery

Information Provided By

University of Lausanne Hospitals

Verification Date

May 2012

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

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