Clinical trial · Interventional
Single-center Randomized Trial for Comparison of Performance Between Domestic and Imported Chemoport
NCT01733342CI-TRIAL-00012813SiCDIPcompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To compare the performance of domestic chemoport and imported chemoport
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Celsite chemoport implantation | Device | — | UNRESOLVED |
| Humanport chemoport implantation | Device | — | UNRESOLVED |
| local anesthesia | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Celsite
- description
- patients received celsite chemoport implantation under local anesthesia
- interventionNames
- Device: Celsite chemoport implantation
- Procedure: local anesthesia
- type
- EXPERIMENTAL
- label
- Humanport
- description
- patients received Humanport chemoport implantation under local anesthesia
- interventionNames
- Procedure: local anesthesia
- Device: Humanport chemoport implantation
Primary outcomes (1)
- measure
- function of chemoport
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDNiederhuber JE, Ensminger W, Gyves JW, Liepman M, Doan K, Cozzi E. Totally implanted venous and arterial access system to replace external catheters in cancer treatment. Surgery. 1982 Oct;92(4):706-12. PMID 7123491
- BACKGROUNDAhn SJ, Kim HC, Chung JW, An SB, Yin YH, Jae HJ, Park JH. Ultrasound and fluoroscopy-guided placement of central venous ports via internal jugular vein: retrospective analysis of 1254 port implantations at a single center. Korean J Radiol. 2012 May-Jun;13(3):314-23. doi: 10.3348/kjr.2012.13.3.314. Epub 2012 Apr 17. PMID 22563269
- BACKGROUNDTeichgraber UK, Kausche S, Nagel SN, Gebauer B. Outcome analysis in 3,160 implantations of radiologically guided placements of totally implantable central venous port systems. Eur Radiol. 2011 Jun;21(6):1224-32. doi: 10.1007/s00330-010-2045-7. Epub 2011 Jan 5. PMID 21207035
- BACKGROUNDTeichgraber UK, Kausche S, Nagel SN. Evaluation of radiologically implanted central venous port systems explanted due to complications. J Vasc Access. 2011 Oct-Dec;12(4):306-12. doi: 10.5301/JVA.2011.7739. PMID 21534232
- BACKGROUNDBiffi R, de Braud F, Orsi F, Pozzi S, Mauri S, Goldhirsch A, Nole F, Andreoni B. Totally implantable central venous access ports for long-term chemotherapy. A prospective study analyzing complications and costs of 333 devices with a minimum follow-up of 180 days. Ann Oncol. 1998 Jul;9(7):767-73. doi: 10.1023/a:1008392423469. PMID 9739444