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

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ClinicalTrials.gov Identifier: NCT01733342
Recruitment Status : Completed
First Posted : November 27, 2012
Last Update Posted : December 4, 2013
Sponsor:
Information provided by (Responsible Party):
Hyo-Cheol Kim, Seoul National University Hospital

Brief Summary:
To compare the performance of domestic chemoport and imported chemoport

Condition or disease Intervention/treatment Phase
Cancer Device: Celsite chemoport implantation Procedure: local anesthesia Device: Humanport chemoport implantation Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Single-center Randomized Trial for Comparison of Performance Between Domestic and Imported Chemoport
Study Start Date : November 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pet Health

Arm Intervention/treatment
Active Comparator: Celsite
patients received celsite chemoport implantation under local anesthesia
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.

Experimental: Humanport
patients received Humanport chemoport implantation under local anesthesia
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




Primary Outcome Measures :
  1. function of chemoport [ Time Frame: 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 :
  1. infection [ Time Frame: 6 months ]
    If infection related with chemoport develop during 6 month follow-up, infection will be recorded.

  2. Skin dehiscence [ Time Frame: 6 months ]
    If skin dehiscence related with chemoport develop during 6 month follow-up, it will be recorded.

  3. deep vein thrombosis [ Time Frame: 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.

  4. Fibrin sheath [ Time Frame: 6 months ]
    If fibrin sheath around chemoport catheter develop during 6 month follow-up, it will be recorded.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733342


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Hyo-Cheol Kim, MD Seoul National University Hospital
Publications:
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Responsible Party: Hyo-Cheol Kim, Clinical Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01733342    
Other Study ID Numbers: HP2012-k
First Posted: November 27, 2012    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: December 2013
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs