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The Side of Implantable Central Vascular Catheters and Complications in Cancer Patients: A Randomization Observational Study

20 Years
Open (Enrolling)
Upper Extremity Deep Vein Thrombosis, Secondary

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Trial Information

The Side of Implantable Central Vascular Catheters and Complications in Cancer Patients: A Randomization Observational Study

Implantable central venous catheters (CVC) are crucial for cancer patients. They provide
central venous access for chemotherapy and high-concentration nutrition support. However,
several potential CVC-related complications may develop and severely interfere with the
patients' cancer treatment and can be life-threatening in some occasions.

Thrombotic events occurred in around 20% of cancer patients with implantable CVCs. Such
events included intraluminal thrombosis and catheter-related venous thrombosis. Catheter
removal was usually necessary to resolve these conditions. Treatment delays are inevitable
for these patients. Besides, these thrombotic complications were associated with
catheter-related infection, which could be highly dangerous for cancer patients.

Risk factors associated with these thrombotic events included the hypercoagulable state of
the patients, the cancer types, the catheter types, and the placement of the catheter tips
in the superior vena cava. Some single-arm studies found that CVC inserted from the left
subclavian veins led to more CVC-related thrombosis than those inserted from the right
subclavian vein. However, for most right-handed patients, to place these implantable CVCs on
the right side is inconvenient for daily life because vigorous exercise was then impossible.
Besides, these single-arm studies could not well control the other potentially interfering
factors, such as the operators, catheter location and cancer types.

Therefore, we plan a randomized observational study to explore whether the side of
implantable CVCs was actually associated with the complication rates. Cancer patients who
need implantable CVCs will be randomized to have the catheters implanted either in the left
subclavian vein or the right subclavian. Patients who had breast cancer, mediastinal mass
with the diameter > 6 cm, ECOG performance score >2, or those who were not able to receive a
standing P-A view chest X-ray will be excluded. Patients who had other reasons that
prevented the randomization will also be excluded. The catheter-related complications will
be actively reported by the patients. We will also enforce the records of complications by
chart reviews and regular telephone contacts.

With the study, we can demonstrate whether a left-sided CVC and a right-sided CVC are
different in complication rates. The result should be very useful in clinical practice.

Inclusion Criteria:

1. Cancer patients who required implantable CVCs

2. Age > 20

3. Not previously implanted with implantable CVCs in subclavian veins.

Exclusion Criteria:

1. Breast cancer patients

2. Mediastinal mass > 6 cm

3. ECOG performance score > 2

4. Not able to receive a standing P-A view chest X-ray exam.

5. One of the subclavian veins has problems preventing randomization

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

complication rates

Outcome Time Frame:

everey 4 weeks

Safety Issue:


Principal Investigator

Yu-Yun Shao, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Taiwan University Hospital


Taiwan: Department of Health

Study ID:




Start Date:

March 2012

Completion Date:

December 2015

Related Keywords:

  • Upper Extremity Deep Vein Thrombosis, Secondary
  • Thrombosis
  • Venous Thrombosis
  • Upper Extremity Deep Vein Thrombosis