Single-center Randomized Trial for Comparison of Performance Between Domestic and Imported Chemoport

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01733342

Acronym

SiCDIP

Enrollment

176

Registered

2012-11-27

Start date

2012-11-30

Completion date

2013-12-31

Last updated

2013-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

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.

Interventions

DEVICECelsite chemoport implantation

Celsite chemoport implantation was done under local anesthesia, at anterior chest wall, under ultrasound guidance

PROCEDURElocal anesthesia

chemoport implantation will be done under local anesthesia using lidocaine.

DEVICEHumanport chemoport implantation

Humanport chemoport implantation was done under local anesthesia, at anterior chest wall, under ultrasound guidance

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
function of chemoport	6 months	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.

Secondary

Measure	Time frame	Description
infection	6 months	If infection related with chemoport develop during 6 month follow-up, infection will be recorded.
Skin dehiscence	6 months	If skin dehiscence related with chemoport develop during 6 month follow-up, it will be recorded.
deep vein thrombosis	6 months	If deep vein thrombosis related with chemoport develop during 6 month follow-up, it will be recorded. Deep vein thrombosis can be develop in the jugular vein which is access route.
Fibrin sheath	6 months	If fibrin sheath around chemoport catheter develop during 6 month follow-up, it will be recorded.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026