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

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Cancer

Treatments: Device: Celsite chemoport implantation; Procedure: local anesthesia; Device: Humanport chemoport implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01733342

HP2012-k

Details and patient eligibility

About

To compare the performance of domestic chemoport and imported chemoport

Full 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.

Enrollment: 176 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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176 participants in 2 patient groups

Celsite

Active Comparator group

Description:

patients received celsite chemoport implantation under local anesthesia

Treatment:

Procedure: local anesthesia

Device: Celsite chemoport implantation

Humanport

Experimental group

Description:

patients received Humanport chemoport implantation under local anesthesia

Treatment:

Device: Humanport chemoport implantation

Procedure: local anesthesia