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

NCT03945045 | Completed

• 1 other identifier: 201807144RINC
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

venous thrombosis

Outcome Measures

Primary Outcomes (5)

• infection (blood stream or local wound)

  1. 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. 2. TIVAD local wound infection and/or non-healing will be classified as infection.

  2 years

• asymptomatic venous thrombosis

  1. asymptomatic venous thrombosis found by study initiated screening ultrasound at 2 weeks, 2 months, and 6 months postoperatively. 2. 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 1. any arm swelling or swelling sensation 2. suspicious pulmonary embolism with symptom as dyspnea, chest tightness/pain, Hemoptysis...etc. Positive confirmatory image tests as 1. vascular sonography 2. Catheter-based angiography 3. Computed tomographic pulmonary angiography (CTPA) or magnetic resonance pulmonary angiography (MRPA) 4. 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.

  1. catheter kinking, looping, migration to different vessel 2. catheter disintegration from port.

  2 years

Secondary Outcomes (1)

• Intolerable pain or foreign body sensation of TIVAD

  2 years

Study Arms (2)

SCV

EXPERIMENTAL

TIVAD implanted through subclavian vein under real-time ultrasound guidance

Procedure: Subclavian vein approach

IJV

EXPERIMENTAL

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

Procedure: internal jugular vein approach

Interventions

Subclavian vein approach PROCEDURE

Subclavian vein approach for Ultrasound-guided Implantation of TIVAD

Also known as: SCV

SCV

internal jugular vein approach PROCEDURE

internal jugular vein approach for Ultrasound-guided Implantation of TIVAD

Also known as: IJV

IJV

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Breast cancer, mediastinal tumor above 6 cm, head and neck cancer with/without surgical/radiological treatment, lung tumor above 6 cm,
• ECOG (Eastern Cooperative Oncology Group)performance status\>=2, can't tolerate sit-upright or standing postoperative chest plain film,
• Allergy to prophylactic antibiotic,
• History of previous TIVAD or Hickman catheter implantation. Recent 2 weeks Central venous catheter insertion.
• End stage renal disease.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei, Taiwan

Location

MeSH Terms

Conditions

Venous Thrombosis; Catheter-Related Infections

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Infections

Study Officials

• CHENG-YUAN HSIEH, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2019
• First Posted: May 10, 2019
• Study Start: May 21, 2019
• Primary Completion: January 25, 2024
• Study Completion: July 7, 2025
• Last Updated: July 27, 2026

Record last verified: 2026-07

Locations

TW (1)