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

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)

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 Overview

• Status: Active, not recruiting
• Conditions: Venous Thrombosis; Catheter-Related Infections; Catheter Mechanical Failure Rate
• Intervention / Treatment: Procedure: Subclavian vein approach; Procedure: internal jugular vein approach

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 Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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; Other Names: SCV
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; Other Names: IJV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
infection (blood stream or local wound)	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.	2 years
asymptomatic venous thrombosis	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.	2 years
symptomatic venous thrombosis with positive confirmatory image tests	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.	2 years
TIVAD catheter occlusion	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 years
major mechanical failure, dislocation of TIVAD.	catheter kinking, looping, migration to different vessel; catheter disintegration from port.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intolerable pain or foreign body sensation of TIVAD	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")	2 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 21, 2019
• Primary Completion (ANTICIPATED): January 1, 2024
• Study Completion (ANTICIPATED): January 1, 2024

Study Registration Dates

• First Submitted: May 5, 2019
• First Submitted That Met QC Criteria: May 8, 2019
• First Posted (ACTUAL): May 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 15, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: venous thrombosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Infections; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Catheter-Related Infections
• Other Study ID Numbers: 201807144RINC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No