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

Cancer Clinical Trial

— SiCDIP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01733342
• Other study ID #: HP2012-k
• Status: Completed
• Phase: Phase 4
• First received: November 13, 2012
• Last updated: December 2, 2013
• Start date: November 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Education, Science, and Technology
• Study type: Interventional

Clinical Trial Summary

To compare the performance of domestic chemoport and imported chemoport

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

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

Procedure:
• local anesthesia
chemoport implantation will be done under local anesthesia using lidocaine.

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

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. — View Citation

Biffi R, de Braud F, Orsi F, Pozzi S, Mauri S, Goldhirsch A, Nolè 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. — View Citation

Niederhuber JE, Ensminger W, Gyves JW, Liepman M, Doan K, Cozzi E. Totally implanted venous and arterial access system to replace external catheters in cancer treatment. Surgery. 1982 Oct;92(4):706-12. — View Citation

Teichgräber 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. — View Citation

Teichgräber 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	infection	If infection related with chemoport develop during 6 month follow-up, infection will be recorded.	6 months	No
Secondary	Skin dehiscence	If skin dehiscence related with chemoport develop during 6 month follow-up, it will be recorded.	6 months	No
Secondary	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	No
Secondary	Fibrin sheath	If fibrin sheath around chemoport catheter develop during 6 month follow-up, it will be recorded.	6 months	No