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
  Purpose

To compare the performance of domestic chemoport and imported chemoport


Condition Intervention Phase
Cancer
Device: Celsite chemoport implantation
Procedure: local anesthesia
Device: Humanport chemoport implantation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Single-center Randomized Trial for Comparison of Performance Between Domestic and Imported Chemoport

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 176
Study Start Date: November 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01733342

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Hyo-Cheol Kim, MD Seoul National University Hospital
  More Information

Publications:
Responsible Party: Hyo-Cheol Kim, Clinical Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01733342     History of Changes
Other Study ID Numbers: HP2012-k
Study First Received: November 13, 2012
Last Updated: December 2, 2013
Health Authority: Korea: Ministry of Education, Science, and Technology

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014