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Completed

NCT Number: NCT01733342

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

To compare the performance of domestic chemoport and imported chemoport

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Key information

Conditions

Cancer Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celsite chemoport implantation

Device

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

local anesthesia

Procedure

chemoport implantation will be done under local anesthesia using lidocaine.

Humanport chemoport implantation

Device

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Acronym: SiCDIP

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 27, 2012
Registry last updated
Dec 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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