Clinical trial NCT03945045: A Study of the IJV or the SCV Approach for Ultrasound-guided Implantation of TIVAD
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Venous Thrombosis
Catheter-Related Infections
Catheter Mechanical Failure Rate
Keywords: venous thrombosis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 201
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: infection (blood stream or local wound)
timeFrame: 2 years
measure: asymptomatic venous thrombosis
timeFrame: 2 years
measure: symptomatic venous thrombosis with positive confirmatory image tests
timeFrame: 2 years
measure: TIVAD catheter occlusion
timeFrame: 2 years
measure: major mechanical failure, dislocation of TIVAD.
timeFrame: 2 years
Secondary outcomes:
measure: Intolerable pain or foreign body sensation of TIVAD
timeFrame: 2 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: CHENG-YUAN HSIEH, MD
role: PRINCIPAL_INVESTIGATOR
References: