Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2019-06-28
2022-07-08
Brief Summary
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Detailed Description
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Clinicians tend to prolong the recommended interval or even to omit the maintenance procedure. Therefore in clinical practice, intervals vary widely among institutions. To the best of our knowledge, a comprehensive investigation of the risks related to catheter patency, bacterial colonization and catheter integrity, has never been performed in patients whose port is electively removed using a 3 months flushing maintenance regimen. To assess the impact of the maintenance interval, patients will be included in the study if the patient's TIVAD is not being used for regularly therapy for a total period of at least one year.
This exploratory study will focus on catheter function and colonisation, tip position and tip thrombosis, sleeve formation, removal problems and also patient experiences at elective planned TIVAD removal therapy.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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TIVAD evaluation
TIVAD evaluation at port removal evaluation of catheter function, visualization of catheter tip, presence of thrombus material and sleeve and any device damage during linogram (contrast injection via TIVAD), tip and chamber content microbiological culture, macroscopic catheter and port chamber evaluation PROM: patient reported outcome measurements regarding TIVAD insertion, presence and removal
Evaluation of the catheter function
Catheter function will be measured by the CINAS (Catheter injection and aspiration classification)
Catheter tip location, thrombus, sleeve and device damage visualization
Catheter tip location, thrombus, sleeve and device damage will be visualized by linogram
Catheter-related colonization
TIVAD colonization will be investigated by microbiological culture of the tip and chamber content
patient-reported outcome measures (PROM) related to the presence of the TIVAD
PROM will evaluate patient's experiences regarding the TIVAD insertion, dwell time, and removal using the Leuven Patient Reported Experiences at Port removal (Leuven PREP) questionnaire.
Macroscopic evaluation of the port chamber and catheter
Macroscopic evaluation of the port chamber and catheter will be performed after port removal.
Interventions
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Evaluation of the catheter function
Catheter function will be measured by the CINAS (Catheter injection and aspiration classification)
Catheter tip location, thrombus, sleeve and device damage visualization
Catheter tip location, thrombus, sleeve and device damage will be visualized by linogram
Catheter-related colonization
TIVAD colonization will be investigated by microbiological culture of the tip and chamber content
patient-reported outcome measures (PROM) related to the presence of the TIVAD
PROM will evaluate patient's experiences regarding the TIVAD insertion, dwell time, and removal using the Leuven Patient Reported Experiences at Port removal (Leuven PREP) questionnaire.
Macroscopic evaluation of the port chamber and catheter
Macroscopic evaluation of the port chamber and catheter will be performed after port removal.
Eligibility Criteria
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Inclusion Criteria
* Patients planned for an elective TIVAD removal under local anaesthesia.
* Patients able to participate in the study and willing to sign an informed consent.
* Patients able to understand and read Dutch.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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B. Braun Medical SA
INDUSTRY
Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Stas Marguerite
Professor Doctor
Principal Investigators
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Marguerite Stas, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Locations
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University Hospitals Leuven
Leuven, , Belgium
Countries
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References
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Goossens GA, Jerome M, Janssens C, Peetermans WE, Fieuws S, Moons P, Verschakelen J, Peerlinck K, Jacquemin M, Stas M. Comparing normal saline versus diluted heparin to lock non-valved totally implantable venous access devices in cancer patients: a randomised, non-inferiority, open trial. Ann Oncol. 2013 Jul;24(7):1892-1899. doi: 10.1093/annonc/mdt114. Epub 2013 Apr 3.
Odabas H, Ozdemir NY, Ziraman I, Aksoy S, Abali H, Oksuzoglu B, Isik M, Civelek B, Dede D, Zengin N. Effect of port-care frequency on venous port catheter-related complications in cancer patients. Int J Clin Oncol. 2014 Aug;19(4):761-6. doi: 10.1007/s10147-013-0609-7. Epub 2013 Aug 27.
Palese A, Baldassar D, Rupil A, Bonanni G, Capellari Maria T, Contessi D, De Crignis L, Vidoni A, Piller Roner S, Zanini A. Maintaining patency in totally implantable venous access devices (TIVAD): a time-to-event analysis of different lock irrigation intervals. Eur J Oncol Nurs. 2014 Feb;18(1):66-71. doi: 10.1016/j.ejon.2013.09.002. Epub 2013 Oct 4.
Diaz JA, Rai SN, Wu X, Chao JH, Dias AL, Kloecker GH. Phase II Trial on Extending the Maintenance Flushing Interval of Implanted Ports. J Oncol Pract. 2017 Jan;13(1):e22-e28. doi: 10.1200/JOP.2016.010843. Epub 2016 Oct 23.
Dal Molin A, Guerretta L, Mazzufero F, Rasero L. The management of totally implanted venous ports in the ambulatory oncologic patient. J Vasc Access. 2009 Jan-Mar;10(1):22-6. doi: 10.1177/112972980901000104.
Goossens GA. Flushing and Locking of Venous Catheters: Available Evidence and Evidence Deficit. Nurs Res Pract. 2015;2015:985686. doi: 10.1155/2015/985686. Epub 2015 May 14.
Ferroni A, Gaudin F, Guiffant G, Flaud P, Durussel JJ, Descamps P, Berche P, Nassif X, Merckx J. Pulsative flushing as a strategy to prevent bacterial colonization of vascular access devices. Med Devices (Auckl). 2014 Nov 7;7:379-83. doi: 10.2147/MDER.S71217. eCollection 2014.
Gristina AG, Giridhar G, Gabriel BL, Naylor PT, Myrvik QN. Cell biology and molecular mechanisms in artificial device infections. Int J Artif Organs. 1993 Nov;16(11):755-63.
Douard MC, Arlet G, Longuet P, Troje C, Rouveau M, Ponscarme D, Eurin B. Diagnosis of venous access port-related infections. Clin Infect Dis. 1999 Nov;29(5):1197-202. doi: 10.1086/313444.
Brouns F, Schuermans A, Verhaegen J, De Wever I, Stas M. Infection assessment of totally implanted long-term venous access devices. J Vasc Access. 2006 Jan-Mar;7(1):24-8. doi: 10.1177/112972980600700105.
Tang S, Beigel R, Arsanjani R, Larson B, Luthringer D, Siegel R. Infective Endovascular Fibrin Sheath Vegetations-A New Cause of Bacteremia Detected by Transesophageal Echocardiogram. Am J Med. 2015 Sep;128(9):1029-38. doi: 10.1016/j.amjmed.2015.03.019. Epub 2015 Apr 10.
Onal B, Coskun B, Karabulut R, Ilgit ET, Turkyilmaz Z, Sonmez K. Interventional radiological retrieval of embolized vascular access device fragments. Diagn Interv Radiol. 2012 Jan-Feb;18(1):87-91. doi: 10.4261/1305-3825.DIR.4098-10.1. Epub 2011 Feb 8.
Kojima S, Hiraki T, Gobara H, Iguchi T, Fujiwara H, Matsui Y, Mitsuhashi T, Kanazawa S. Fracture of totally implanted central venous access devices: a propensity-score-matched comparison of risks for Groshong silicone versus polyurethane catheters. J Vasc Access. 2016 Nov 2;17(6):535-541. doi: 10.5301/jva.5000606. Epub 2016 Oct 21.
Goossens GA, De Waele Y, Jerome M, Fieuws S, Janssens C, Stas M, Moons P. Diagnostic accuracy of the Catheter Injection and Aspiration (CINAS) classification for assessing the function of totally implantable venous access devices. Support Care Cancer. 2016 Feb;24(2):755-761. doi: 10.1007/s00520-015-2839-x. Epub 2015 Jul 26.
Bouza E, Martin-Rabadan P, Echenagusia A, Camunez F, Rodriguez-Rosales G, Simo G, Echenagusia M, Guembe M; GEIDI study group. Diagnosis of venous access port colonization requires cultures from multiple sites: should guidelines be amended? Diagn Microbiol Infect Dis. 2014 Feb;78(2):162-7. doi: 10.1016/j.diagmicrobio.2013.11.004. Epub 2013 Nov 14.
Marcy PY, Dahlet C, Brenet O, Yazbec G, Dubois PY, Salm B, Fouche Y, Mari V, Montastruc M, Lebrec N, Ancel B, Paillocher N, Dupoiron D, Rangeard O, Michel C, Chateau Y, Ettaiche M, Ferrero JM, Chamorey E. [Multicenter validation study of a questionnaire assessing patient satisfaction with and acceptance of totally-implanted central venous access devices]. Bull Cancer. 2015 Apr;102(4):301-15. doi: 10.1016/j.bulcan.2015.02.012. Epub 2015 Mar 21. French.
Goossens GA, Vrebos M, De Wever I, Stas M. Vacutainer filling time through subcutaneous venous access devices. J Vasc Access. 2004 Oct-Dec;5(4):154-60. doi: 10.1177/112972980400500404.
Goossens GA, Douchy T, Jerome M, Peeters Y, Hompes D, Boecxstaens V. Port REMoval Outcomes (PREMO) study: Patients' experiences with a Totally Implantable Venous Access Device: A questionnaire at device removal. J Vasc Access. 2025 May 27:11297298251340461. doi: 10.1177/11297298251340461. Online ahead of print.
Douchy T, Hompes D, Maleux G, Jerome M, Peeters Y, Goossens GA, Boecxstaens V. Port REMoval Outcomes (PREMO) study: A pilot study for functional, microbial, radiological, and macroscopic assessment of totally implantable venous access devices. J Vasc Access. 2025 May 13:11297298251335416. doi: 10.1177/11297298251335416. Online ahead of print.
Other Identifiers
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S62321
Identifier Type: -
Identifier Source: org_study_id
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