Clinical trial NCT01733342: Single-center Randomized Trial for Comparison of Performance Between Domestic and Imported Chemoport
Official title: Single-center Randomized Trial for Comparison of Performance Between Domestic and Imported Chemoport
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cancer
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-11-27
Enrollment: 176
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the performance of domestic chemoport and imported chemoport

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: function of chemoport
timeFrame: 6 months
Secondary outcomes:
measure: infection
timeFrame: 6 months
measure: Skin dehiscence
timeFrame: 6 months
measure: deep vein thrombosis
timeFrame: 6 months
measure: Fibrin sheath
timeFrame: 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hyo-Cheol Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Ahn SJ, Kim HC, Chung JW, An SB, Yin YH, Jae HJ, Park JH. Ultrasound and fluoroscopy-guided placement of central venous ports via internal jugular vein: retrospective analysis of 1254 port implantations at a single center. Korean J Radiol. 2012 May-Jun;13(3):314-23. doi: 10.3348/kjr.2012.13.3.314. Epub 2012 Apr 17.
citation: Teichgraber UK, Kausche S, Nagel SN, Gebauer B. Outcome analysis in 3,160 implantations of radiologically guided placements of totally implantable central venous port systems. Eur Radiol. 2011 Jun;21(6):1224-32. doi: 10.1007/s00330-010-2045-7. Epub 2011 Jan 5.
citation: Teichgraber UK, Kausche S, Nagel SN. Evaluation of radiologically implanted central venous port systems explanted due to complications. J Vasc Access. 2011 Oct-Dec;12(4):306-12. doi: 10.5301/JVA.2011.7739.
citation: Biffi R, de Braud F, Orsi F, Pozzi S, Mauri S, Goldhirsch A, Nole F, Andreoni B. Totally implantable central venous access ports for long-term chemotherapy. A prospective study analyzing complications and costs of 333 devices with a minimum follow-up of 180 days. Ann Oncol. 1998 Jul;9(7):767-73. doi: 10.1023/a:1008392423469.