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

NCT ID: NCT03945045

Last Updated: 2022-08-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-21
• Study Completion Date: 2024-01-31

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.

Conditions

Venous Thrombosis; Catheter-Related Infections; Catheter Mechanical Failure Rate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

SCV

TIVAD implanted through subclavian vein under real-time ultrasound guidance

Group Type: EXPERIMENTAL

Subclavian vein approach

Intervention Type: PROCEDURE

Subclavian vein approach for Ultrasound-guided Implantation of TIVAD

IJV

TIVAD implanted through internal jugular vein under real-time ultrasound guidance

Group Type: EXPERIMENTAL

internal jugular vein approach

Intervention Type: PROCEDURE

internal jugular vein approach for Ultrasound-guided Implantation of TIVAD

Interventions

Subclavian vein approach

Subclavian vein approach for Ultrasound-guided Implantation of TIVAD

Intervention Type: PROCEDURE

internal jugular vein approach

internal jugular vein approach for Ultrasound-guided Implantation of TIVAD

Intervention Type: PROCEDURE

Other Intervention Names

SCV; IJV

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

CHENG-YUAN HSIEH, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

201807144RINC

Identifier Type: -

Identifier Source: org_study_id