UnknownNot Applicable

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

Taiwan201 participantsStarted 2019-05-21

Plain-language 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.

Who can participate

Age range

20 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

infection (blood stream or local wound)

Timeframe: 2 years

asymptomatic venous thrombosis

Timeframe: 2 years

symptomatic venous thrombosis with positive confirmatory image tests

Timeframe: 2 years

TIVAD catheter occlusion

Timeframe: 2 years

major mechanical failure, dislocation of TIVAD.

Timeframe: 2 years

Trial details

NCT IDNCT03945045

SponsorNational Taiwan University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01

View on ClinicalTrials.gov More Venous Thrombosis trials

Plain-language summary

Who can participate

Age range

20 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. 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.

What they're measuring

infection (blood stream or local wound)

Timeframe: 2 years

asymptomatic venous thrombosis

Timeframe: 2 years

symptomatic venous thrombosis with positive confirmatory image tests

Timeframe: 2 years

TIVAD catheter occlusion

Timeframe: 2 years

major mechanical failure, dislocation of TIVAD.

Timeframe: 2 years