Clinical trial · Interventional
PREMO Study: to Investigate Port REMoval Outcomes
Pilot Trial to Assess Functional, Microbial, Radiological and Patient Reported Outcomes at Totally Implantable Venous Access Device (Port) Removal (PREMO Study)
NCT03948958CI-TRIAL-00060284PREMOcompletedN/AClinicalTrials.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)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cystic Fibrosis | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Catheter-related colonization | Other | — | UNRESOLVED |
| Catheter tip location, thrombus, sleeve and device damage visualization | Other | — | UNRESOLVED |
| Evaluation of the catheter function | Other | — | UNRESOLVED |
| Macroscopic evaluation of the port chamber and catheter | Other | — | UNRESOLVED |
| patient-reported outcome measures (PROM) related to the presence of the TIVAD | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TIVAD evaluation
- description
- 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
- interventionNames
- Other: Evaluation of the catheter function
- Other: Catheter tip location, thrombus, sleeve and device damage visualization
- Other: Catheter-related colonization
- Other: patient-reported outcome measures (PROM) related to the presence of the TIVAD
- Other: Macroscopic evaluation of the port chamber and catheter
Primary outcomes (1)
- measure
- TIVAD function
- timeFrame
- during the 1 day of TIVAD removal, before the linogram
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (19)
- BACKGROUNDGoossens 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. PMID 23553060
- BACKGROUNDOdabas 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. PMID 23978939
- BACKGROUNDPalese 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. PMID 24100090
- BACKGROUNDDiaz 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. PMID 28084883
- BACKGROUNDDal 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. PMID 19340795
- BACKGROUNDGoossens 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. PMID 26075094
- BACKGROUNDFerroni 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.