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

NCT ID: NCT01733342

Last Updated: 2013-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-12-31

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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Celsite

patients received celsite chemoport implantation under local anesthesia

Group Type ACTIVE_COMPARATOR

Celsite chemoport implantation

Intervention Type DEVICE

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

local anesthesia

Intervention Type PROCEDURE

chemoport implantation will be done under local anesthesia using lidocaine.

Humanport

patients received Humanport chemoport implantation under local anesthesia

Group Type EXPERIMENTAL

local anesthesia

Intervention Type PROCEDURE

chemoport implantation will be done under local anesthesia using lidocaine.

Humanport chemoport implantation

Intervention Type DEVICE

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

Interventions

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Celsite chemoport implantation

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

Intervention Type DEVICE

local anesthesia

chemoport implantation will be done under local anesthesia using lidocaine.

Intervention Type PROCEDURE

Humanport chemoport implantation

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

Intervention Type DEVICE

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyo-Cheol Kim

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyo-Cheol Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 7123491 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22563269 (View on PubMed)

Teichgraber 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.

Reference Type BACKGROUND
PMID: 21207035 (View on PubMed)

Teichgraber 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.

Reference Type BACKGROUND
PMID: 21534232 (View on PubMed)

Biffi R, de Braud F, Orsi F, Pozzi S, Mauri S, Goldhirsch A, Nole 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. doi: 10.1023/a:1008392423469.

Reference Type BACKGROUND
PMID: 9739444 (View on PubMed)

Other Identifiers

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HP2012-k

Identifier Type: -

Identifier Source: org_study_id