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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hyo-Cheol Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01733342
First received: November 13, 2012
Last updated: December 2, 2013
Last verified: December 2013

November 13, 2012
December 2, 2013
November 2012
December 2013   (final data collection date for primary outcome measure)
function of chemoport [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01733342 on ClinicalTrials.gov Archive Site
  • infection [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    If infection related with chemoport develop during 6 month follow-up, infection will be recorded.
  • Skin dehiscence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    If skin dehiscence related with chemoport develop during 6 month follow-up, it will be recorded.
  • deep vein thrombosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    If fibrin sheath around chemoport catheter develop during 6 month follow-up, it will be recorded.
Same as current
Not Provided
Not Provided
 
Single-center Randomized Trial for Comparison of Performance Between Domestic and Imported Chemoport
Single-center Randomized Trial for Comparison of Performance Between Domestic and Imported Chemoport

To compare the performance of domestic chemoport and imported chemoport

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Cancer
  • 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
  • Active Comparator: Celsite
    patients received celsite chemoport implantation under local anesthesia
    Interventions:
    • Device: Celsite chemoport implantation
    • Procedure: local anesthesia
  • Experimental: Humanport
    patients received Humanport chemoport implantation under local anesthesia
    Interventions:
    • Procedure: local anesthesia
    • Device: Humanport chemoport implantation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
176
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01733342
HP2012-k
Yes
Hyo-Cheol Kim, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Principal Investigator: Hyo-Cheol Kim, MD Seoul National University Hospital
Seoul National University Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP