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

Study Overview
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Brief Summary
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To compare the performance of domestic chemoport and imported chemoport

Detailed Description
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Device: Celsite chemoport implantation
* Procedure: local anesthesia
* Device: Humanport chemoport implantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Celsite<br>patients received celsite chemoport implantation under local anesthesia | Device: Celsite chemoport implantation<br>* Celsite chemoport implantation was done under local anesthesia, at anterior chest wall, under ultrasound guidance<br>Procedure: local anesthesia<br>* chemoport implantation will be done under local anesthesia using lidocaine.<br>|
| Experimental: Humanport<br>patients received Humanport chemoport implantation under local anesthesia | Procedure: local anesthesia<br>* chemoport implantation will be done under local anesthesia using lidocaine.<br>Device: Humanport chemoport implantation<br>* Humanport chemoport implantation was done under local anesthesia, at anterior chest wall, under ultrasound guidance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| function of chemoport | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| infection | If infection related with chemoport develop during 6 month follow-up, infection will be recorded. | 6 months | 
| Skin dehiscence | If skin dehiscence related with chemoport develop during 6 month follow-up, it will be recorded. | 6 months | 
| deep vein thrombosis | 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. | 6 months | 
| Fibrin sheath | If fibrin sheath around chemoport catheter develop during 6 month follow-up, it will be recorded. | 6 months |