Vascular Surgical ProceduresNCT01584193
Ultrasound-guided Subclavian Vein Puncture Versus Cephalic Vein Dissection for Venous Access Port Implantation
A study testing Ultrasound-guided subclavian vein puncture and Cephalic vein dissection in people with Vascular Surgical Procedures, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Surgical Procedures
- What is being tested?
- Ultrasound-guided subclavian vein puncture and Cephalic vein dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- Informed consent
- Need for central venous access port implementation under local anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Lausanne, Department of Visceral Surgery
Lausanne, Canton of Vaud, 1011
About this study
Official title: Ultrasound-guided Subclavian Vein Puncture Versus Cephalic Vein Dissection for Totally Implantable Venous Access Port Implementation: a Single-center Controlled Randomized Superiority Trial
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.
- Conditions
- Vascular Surgical Procedures
- Being tested
- Ultrasound-guided subclavian vein puncture, Cephalic vein dissection
- Keywords
- central venous access port, ultrasound-guided venous puncture, suclavian vein, cephalic vein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided subclavian vein punctureProcedure or surgery
Also called US-guided, Seldinger technique
Central venous access port implementation through ultrasound-guided subclavian vein puncture and Seldinger technique
Cephalic vein dissectionProcedure or surgery
Also called Venous cutdown
Central venous access port implementation through cephalic vein dissection and cutdown
| Study group | Role | What they receive |
|---|---|---|
| US-guided subclavian vein puncture | Experimental | Not described Receives: Procedure: Ultrasound-guided subclavian vein puncture |
| Cephalic vein dissection | Active comparator | Not described Receives: Procedure: Cephalic vein dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical procedure time
Measured: during surgical procedure
Secondary outcomes (9)
primary implementation success rate
Measured: during surgical procedure
overall implementation success rate
Measured: during surgical procedure
technique conversion rate and causes
Measured: during surgical procedure
pain during surgical procedure
Measured: during surgical procedure
pain at 5 days
Measured: 5 days post-procedure
Pain at 30 days
Measured: 30 days post-procedure
Complications rate during surgical procedure
catheter malposition, hemorrhage, hemotoma, hemothorax, pneumothorax
Measured: during surgical procedure
Complications rate at 5 days
hematoma, infection, symptomatic venous thrombosis, pneumothorax
Measured: 5 days post-procedure
Complications rate at 30 days
infection, symptomatic venous thrombosis, pneumothorax, venous access port dysfunction
Measured: 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startJun 2013
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Logistical reasons (institutional reorganization of ambulatory surgery)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas DEMARTINES, University of Lausanne Hospitals
- Investigators
- Nicolas Demartines, Study chair, University Hospital Lausanne, Department of Visceral Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584193
- Sponsor's protocol ID
- CHV 46/11
- Status last verified
- Oct 2018
- First submitted
- 21 Apr 2012
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Subclavian Vein Puncture Versus Cephalic Vein Dissection for Totally Implantable Venous Access Port Implementation: a Single-center Controlled Randomized Superiority Trial
- ClinicalTrials.gov ID
- NCT01584193
- Acronym / sponsor ID
- CHV 46/11
- Conditions
- Vascular Surgical Procedures
- Keywords
- central venous access port, ultrasound-guided venous puncture, suclavian vein, cephalic vein
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Logistical reasons (institutional reorganization of ambulatory surgery)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| US-guided subclavian vein puncture | Experimental | Procedure: Ultrasound-guided subclavian vein puncture |
| Cephalic vein dissection | Active comparator | Procedure: Cephalic vein dissection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18
- Informed consent
- Need for central venous access port implementation under local anesthesia
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-guided subclavian vein punctureAlso: US-guided, Seldinger techniqueCentral venous access port implementation through ultrasound-guided subclavian vein puncture and Seldinger technique | Procedure or surgery | US-guided subclavian vein puncture |
| Cephalic vein dissectionAlso: Venous cutdownCentral venous access port implementation through cephalic vein dissection and cutdown | Procedure or surgery | Cephalic vein dissection |
Primary outcome
surgical procedure time
Time frame: during surgical procedure
9 secondary outcomes
primary implementation success rate
Time frame: during surgical procedure
overall implementation success rate
Time frame: during surgical procedure
technique conversion rate and causes
Time frame: during surgical procedure
pain during surgical procedure
Time frame: during surgical procedure
pain at 5 days
Time frame: 5 days post-procedure
Pain at 30 days
Time frame: 30 days post-procedure
Complications rate during surgical procedure
Time frame: during surgical procedure
Complications rate at 5 days
Time frame: 5 days post-procedure
Complications rate at 30 days
Time frame: 30 days post-procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
Related trials for Vascular Surgical Procedures
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingObservational study
Registry of Ehlers-Danlos Syndrome
Ehlers-Danlos Syndrome
Recruiting
Middle Meningeal Artery Embolisation in Chronic Subdural Hematoma
Chronic Subdural Hematoma
Not yet recruitingObservational study
Assessment of Transnational Performance of the Universal Cardiac Surgical Risk Score Across International Sites
Heart Valve Diseases, Cardiac Surgical Procedures
Active, not recruiting
This Research Proposal Focuses on Evaluating the Effectiveness of a Nursing Care Protocol in Preventing Deep Vein Thrombosis (DVT) in Patients Undergoing On-pump Cardiac Surgery. The Study Will Include an Intervention Group That Receives the Nursing Protocol and a Control Group That Receives Routine
On-pump Cardiac Surgery - Prevention - Intervention - Experimental Group - Control Group - Incidence - Complications, DVT - Deep Vein Thrombosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Demartines study chair
University Hospital Lausanne, Department of Visceral Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided subclavian vein puncture and Cephalic vein dissection in people with Vascular Surgical Procedures, run by University of Lausanne Hospitals at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgical procedure time (time frame: during surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.