About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

378040 studies
in
220 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

A Study of the IJV or the SCV Approach for Ultrasound-guided Implantation of TIVAD

Clinicaltrials.gov identifier NCT03945045

Recruitment Status Recruiting

First Posted May 10, 2019

Last update posted June 18, 2020

Study Description

Brief summary:

To compare IJV and SCV as the implantation site of TIVAD and its associated thrombotic or occlusion rate, our study plans to enroll 240 patients with cancer who require central line TIVADs and randomizes them with 1:1 ratio to receive the TIVAD implantation at SCV or IJV. After the implantation, the patients will be regularly followed through phone contact and chart review for 2 years, and any symptomatic thrombosis or occlusion will be found during chemotherapy injection or regular push-pull heparin saline flush every 6 weeks as our hospital care protocol. To detect any asymptomatic thrombosis, the patients will also receive screening vascular ultrasound at 2 weeks, 2 months, and 6 months postoperatively. The study primary endpoints include any infection, asymptomatic thrombosis found by screen ultrasound, and clinically symptomatic thrombosis or occlusion and major mechanical failure/dislocation of TIVAD.

  • Condition or Disease:Venous Thrombosis
    Catheter-Related Infections
    Catheter Mechanical Failure Rate
  • Intervention/Treatment: Procedure: Subclavian vein approach
    Procedure: internal jugular vein approach
  • Phase: N/A
Detailed Description

A totally implantable venous access device (TIVAD) provides reliable, long-term vascular access and improves cancer patients' quality of life. The use of TIVADs is associated with important complications as infection and venous thrombosis, and studies have shown that several factors are associated, such as cancer types, catheter types, and the location of the catheter tips. Whether subclavian vein(SCV)or internal jugular vein(IJV) is a better site for TIVAD percutaneous access were also widely studied, and there is no definite consensus generated yet. A meta-analysis published in 2016 by Wu et al reviewed 12 studies comparing the internal jugular vein (IJV) with the subclavian vein (SCV) as the percutaneous access site found no differences of TIVAD-related infection and catheter-related thrombotic rate. In the secondary outcome, IJV was associated with reduced risks of total major mechanical complications such as catheter dislocation and malfunction. Of 12 studies included, only 3 were randomized trial and there was no consistency between groups of using ultrasound guidance throughout TIVAD insertion. To be further, there is no description of how close to IJV-SCV junction does IJV group were inserted. Hence, a large well-designed RCT is warranted before the IJV site can be recommended. To compare IJV and SCV as the implantation site of TIVAD and its associated thrombotic or occlusion rate, our study plans to enroll 240 patients with cancer who require central line TIVADs and randomizes them with 1:1 ratio to receive the TIVAD implantation at SCV or IJV. After the implantation, the patients will be regularly followed through phone contact and chart review for 2 years, and any symptomatic thrombosis or occlusion will be found during chemotherapy injection or regular push-pull heparin saline flush every 6 weeks as our hospital care protocol. To detect any asymptomatic thrombosis, the patients will also receive screening vascular ultrasound at 2 weeks, 2 months, and 6 months postoperatively. The study primary endpoints include any infection, asymptomatic thrombosis found by screen ultrasound, and clinically symptomatic thrombosis or occlusion and major mechanical failure/dislocation of TIVAD.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 240 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Prevention
  • Official Title: A Randomized Observational Study of the Internal Jugular Vein or the Subclavian Vein Approach for Ultrasound-guided Implantation of Totally Implantable Vascular Access Device(TIVAD)
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: January 2024
  • Estimated Study Completion Date: January 2024
Arms and interventions
Arm Intervention/treatment
Experimental: SCV
TIVAD implanted through subclavian vein under real-time ultrasound guidance
Procedure: Subclavian vein approach
Subclavian vein approach for Ultrasound-guided Implantation of TIVAD
Experimental: IJV
TIVAD implanted through internal jugular vein under real-time ultrasound guidance
Procedure: internal jugular vein approach
internal jugular vein approach for Ultrasound-guided Implantation of TIVAD
Outcome Measures
  • Primary Outcome Measures: 1. TIVAD catheter occlusion [ Time Frame: 2 years ]
    Failure or difficult to infuse fluid or withdraw blood from TIVAD. Difficult to withdraw blood from TIVAD in certain body position is not counted.
  • 2. major mechanical failure, dislocation of TIVAD. [ Time Frame: 2 years ]
    catheter kinking, looping, migration to different vessel catheter disintegration from port.
  • 3. infection (blood stream or local wound) [ Time Frame: 2 years ]
    catheter-related blood stream infection(CRBSI) due to TIVAD, including: 1-1. at least one positive blood culture obtained from a peripheral vein, clinical manifestations of infections (i.e., fever, chills, and/or hypotension), and no apparent source for the blood stream infection, except the TIVAD, which leads to the TIVAD removal. Subsequent TIVAD catheter tip culture yields the same organism. 1-2. Differential time to positivity, with blood culture drawn from the TIVAD that becomes positive at least 2 hr earlier than the peripheral blood culture. TIVAD local wound infection and/or non-healing will be classified as infection.
  • 4. asymptomatic venous thrombosis [ Time Frame: 2 years ]
    asymptomatic venous thrombosis found by study initiated screening ultrasound at 2 weeks, 2 months, and 6 months postoperatively. asymptomatic venous thrombosis found by chart review of chest CT/plain film, if exams are available due to other medical indication within 2 years postoperatively.
  • 5. symptomatic venous thrombosis with positive confirmatory image tests [ Time Frame: 2 years ]
    both positive symptoms and positive confirmative image tests should be met. Positive symptom noted by the patient or caregiver, such as any arm swelling or swelling sensation suspicious pulmonary embolism with symptom as dyspnea, chest tightness/pain, Hemoptysis...etc. Positive confirmatory image tests as vascular sonography Catheter-based angiography Computed tomographic pulmonary angiography (CTPA) or magnetic resonance pulmonary angiography (MRPA) Ventilation perfusion (V/Q) scanning when pulmonary embolism is suspected.
  • Secondary Outcome Measures: 1. Intolerable pain or foreign body sensation of TIVAD [ Time Frame: 2 years ]
    Subjectively, intolerable "pain or foreign body sensation" of TIVAD, which leads to TIVAD remove without other medical reasons. Patient requests for TIVAD remove with no pain, no foreign body sensation, and no other medical reasons will not be included in the measure. (that is, "I want to remove TIVAD because TIVAD is an implant")
Eligibility Criteria
  • Ages Eligible for Study: 20 to 99 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion: 240 cancer patients, 20~99 years old.

Exclusion:

1. Breast cancer, mediastinal tumor above 6 cm, head and neck cancer with/without
surgical/radiological treatment, lung tumor above 6 cm,

2. ECOG (Eastern Cooperative Oncology Group)performance status>=2, can't tolerate
sit-upright or standing postoperative chest plain film,

3. Allergy to prophylactic antibiotic,

4. History of previous TIVAD or Hickman catheter implantation. Recent 2 weeks Central
venous catheter insertion.

5. End stage renal disease.

Contacts and Locations
Contacts

Contact: CHENG-YUAN HSIEH, MD +886972652330 isaac216@gmail.com

Contact: CHENG-YUAN HSIEH, MD +886975386007

Locations

Taiwan
National Taiwan University Hospital
Taipei

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

Principal Investigator: CHENG-YUAN HSIEH, MD National Taiwan University Hospital

More Information
  • Responsible Party: National Taiwan University Hospital
  • ClinicalTrials.gov Identifier: NCT03945045 History of Changes
  • Other Study ID Numbers: 201807144RINC
  • First Posted: May 10, 2019 Key Record Dates
  • Last Update Posted: June 18, 2020
  • Last Verified: June 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by National Taiwan University Hospital: venous thrombosis
  • Additional relevant MeSH terms: Thrombosis
    Catheter-Related Infections
    Venous Thrombosis