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

December 2, 2013 updated by: Hyo-Cheol Kim, Seoul National University Hospital
To compare the performance of domestic chemoport and imported chemoport

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
infection
Time Frame: 6 months
If infection related with chemoport develop during 6 month follow-up, infection will be recorded.
6 months
Skin dehiscence
Time Frame: 6 months
If skin dehiscence related with chemoport develop during 6 month follow-up, it will be recorded.
6 months
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.
6 months
Fibrin sheath
Time Frame: 6 months
If fibrin sheath around chemoport catheter develop during 6 month follow-up, it will be recorded.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Hyo-Cheol Kim, MD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

November 13, 2012

First Submitted That Met QC Criteria

November 20, 2012

First Posted (Estimate)

November 27, 2012

Study Record Updates

Last Update Posted (Estimate)

December 4, 2013

Last Update Submitted That Met QC Criteria

December 2, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP2012-k

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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