Single-center Randomized Trial for Comparison of Performance Between Domestic and Imported Chemoport
20 Years
N/A
Both
Cancer
Trial Information
Single-center Randomized Trial for Comparison of Performance Between Domestic and Imported Chemoport
chemoport implantation was done by two investigator Chemoport type was randomly rendered.
Domestic chemoport(Human port) and imported chemoport (Celsite) were used. chemoport
function will be followed up.
Inclusion Criteria:
- patients who will receive chemotherapy via implantable port
- age >20 years
- expected life time > 6 months
- lab test (platelet>50K, PT INR <2.0)
Exclusion Criteria:
- performance status >2
- brain metastasis
- expected life time less than 6 months
- age less than 20 years
- active infection
- severe heart dysfunction
- recent myocardial infarct
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
function of chemoport
Outcome Description:
Whether or not chemoport function is intact will be assessed. Chemoport function will be rendered as intact when chemotherapeutic agent is well infused through the chemoport. Chemoport function will be rendered as not intact when chemotherapeutic agent could be infused through the chemoport.
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Hyo-Cheol Kim, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Seoul National University Hospital
Authority:
Korea: Ministry of Education, Science, and Technology
Study ID:
HP2012-k
NCT ID:
NCT01733342
Start Date:
November 2012
Completion Date:
December 2013
Related Keywords:
- Cancer
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