NCT01584193

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2012

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

October 23, 2018

Status Verified

October 1, 2018

Enrollment Period

1.5 years

First QC Date

April 21, 2012

Last Update Submit

October 22, 2018

Conditions

Vascular Surgical Procedures

Keywords

central venous access portultrasound-guided venous puncturesuclavian veincephalic vein

Outcome Measures

Primary Outcomes (1)

  • surgical procedure time

    during surgical procedure

Secondary Outcomes (9)

  • primary implementation success rate

    during surgical procedure

  • overall implementation success rate

    during surgical procedure

  • technique conversion rate and causes

    during surgical procedure

  • pain during surgical procedure

    during surgical procedure

  • pain at 5 days

    5 days post-procedure

  • +4 more secondary outcomes

Study Arms (2)

US-guided subclavian vein puncture

EXPERIMENTAL
Procedure: Ultrasound-guided subclavian vein puncture

Cephalic vein dissection

ACTIVE COMPARATOR
Procedure: Cephalic vein dissection

Interventions

Ultrasound-guided subclavian vein puncturePROCEDURE

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

Also known as: US-guided, Seldinger technique
US-guided subclavian vein puncture
Cephalic vein dissectionPROCEDURE

Central venous access port implementation through cephalic vein dissection and cutdown

Also known as: Venous cutdown
Cephalic vein dissection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Lausanne, Department of Visceral Surgery

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Interventions

Venous Cutdown

Intervention Hierarchy (Ancestors)

Vascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Nicolas Demartines

    University Hospital Lausanne, Department of Visceral Surgery

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 21, 2012

First Posted

April 24, 2012

Study Start

June 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

October 23, 2018

Record last verified: 2018-10

Locations

CH(1)