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

NCT ID: NCT01584193

Last Updated: 2018-10-23

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Vascular Surgical Procedures

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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US-guided subclavian vein puncture

Group Type EXPERIMENTAL

Ultrasound-guided subclavian vein puncture

Intervention Type PROCEDURE

Central venous access port implementation through ultrasound-guided subclavian vein puncture and Seldinger technique

Cephalic vein dissection

Group Type ACTIVE_COMPARATOR

Cephalic vein dissection

Intervention Type PROCEDURE

Central venous access port implementation through cephalic vein dissection and cutdown

Interventions

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Ultrasound-guided subclavian vein puncture

Central venous access port implementation through ultrasound-guided subclavian vein puncture and Seldinger technique

Intervention Type PROCEDURE

Cephalic vein dissection

Central venous access port implementation through cephalic vein dissection and cutdown

Intervention Type PROCEDURE

Other Intervention Names

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US-guided Seldinger technique Venous cutdown

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Lausanne Hospitals

OTHER

Sponsor Role lead

Responsible Party

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Nicolas DEMARTINES

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicolas Demartines

Role: STUDY_CHAIR

University Hospital Lausanne, Department of Visceral Surgery

Locations

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University Hospital Lausanne, Department of Visceral Surgery

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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CHV 46/11

Identifier Type: -

Identifier Source: org_study_id

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