PREMO Study: to Investigate Port REMoval Outcomes

Cystic Fibrosis Clinical Trial

— PREMO  

Official title:

Pilot Trial to Assess Functional, Microbial, Radiological and Patient Reported Outcomes at Totally Implantable Venous Access Device (Port) Removal (PREMO Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03948958
• Other study ID #: S62321
• Status: Completed
• Phase: N/A
• Start date: June 28, 2019
• Est. completion date: July 8, 2022

Study information

• Verified date: August 2022
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Totally Implantable Venous Access Device (TIVAD) that is no longer in use for intravenous therapy, should be flushed at established intervals to promote and maintain patency. No consensus has been established regarding the optimal duration of the interval between 2 maintenance sessions. This exploratory study will focus on catheter status under the current 3-monthly flush regimen.

Description:

A Totally Implantable Venous Access Device (TIVAD) or so called implantable port that is no longer in use for intravenous therapy, should be removed or flushed at established intervals to promote and maintain patency. The maintenance procedure consists of a 10 ml 0.9% sodium chloride pulsatile flush. No consensus has been established regarding the optimal duration of the interval between 2 maintenance sessions. In het university hospitals Leuven the current interval is 3 months. Studies confirmed the safety and efficacy of an extended maintenance interval to once every 4 months. Many patients have relatively poor compliance with their regular port flushing procedure.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 8, 2022
• Est. primary completion date: July 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients of 18 years and older, with a TIVAD that is no longer used for intravenous therapy on a regular basis for the past 365 days after completing initially planned treatment.

• 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:

• History of fever and/or chills following last flushing procedure

Related Conditions & MeSH terms

• Cystic Fibrosis
• Neoplasms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	B. Braun Medical SA

Country where clinical trial is conducted

Belgium, 

References & Publications (17)

Bouza E, Martín-Rabadán P, Echenagusia A, Camúñez F, Rodríguez-Rosales G, Simó 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Goossens GA, De Waele Y, Jérôme 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. — View Citation

Goossens GA, Jérôme 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Önal B, Coskun B, Karabulut R, Ilgit ET, Türkyilmaz Z, Sönmez 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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient-reported outcome measure	Patient's experiences will be collected by means of the Leuven Patient Reported Experiences at Port removal (Leuven PREP) questionnaire a self-reported 25-items questionnaire	during the 1 day of TIVAD removal
Primary	TIVAD function	will be assessed in terms of both injection and aspiration abilities. The ability is scored as easy, difficult or impossible along the Catheter Injection and Aspiration (CINAS) classification.	during the 1 day of TIVAD removal, before the linogram
Secondary	Catheter tip position visualization by fluoroscopy	The patient will be positioned in a nearly standing position with chest elevation of 17°	during the 1 day of TIVAD removal, just before the linogram
Secondary	Port chamber filling, sleeve formation, sleeve extend, catheter tip thrombosis and damage in port chamber or catheter trajectory	will be visualised by linogram (digital substraction angiography)	during the 1 day of TIVAD removal
Secondary	Catheter tip and port chamber culture	microbial culture	during the 1 day of TIVAD removal (following TIVAD removal)