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

Phase 4

Completed

• Conditions: Cancer
• Interventions: Device: Celsite chemoport implantation; Procedure: local anesthesia; Device: Humanport chemoport implantation

• Registration Number: NCT01733342
• Lead Sponsor: Seoul National University Hospital

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-13
• Study First Submitted QC: 2012-11-20
• Study First Posted: 2012-11-27
• Status Verified: 2013-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2013-12-02
• Last Update Posted: 2013-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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)

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Celsite	Celsite chemoport implantation	patients received celsite chemoport implantation under local anesthesia
Celsite	local anesthesia	patients received celsite chemoport implantation under local anesthesia
Humanport	local anesthesia	patients received Humanport chemoport implantation under local anesthesia
Humanport	Humanport chemoport implantation	patients received Humanport chemoport implantation under local anesthesia

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of