PREMO Study: to Investigate Port REMoval Outcomes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Neoplasms, Cystic Fibrosis

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TIVAD evaluation<br>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 | Other: Evaluation of the catheter function<br>* Catheter function will be measured by the CINAS (Catheter injection and aspiration classification)<br>Other: Catheter tip location, thrombus, sleeve and device damage visualization<br>* Catheter tip location, thrombus, sleeve and device damage will be visualized by linogram<br>Other: Catheter-related colonization<br>* TIVAD colonization will be investigated by microbiological culture of the tip and chamber content<br>Other: patient-reported outcome measures (PROM) related to the presence of the TIVAD<br>* 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.<br>Other: Macroscopic evaluation of the port chamber and catheter<br>* Macroscopic evaluation of the port chamber and catheter will be performed after port removal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Catheter tip and port chamber culture | microbial culture | during the 1 day of TIVAD removal (following TIVAD removal) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vascular Access Devices, Implantable port, Flush interval, Catheter function, Catheter-related infection, Catheter tip location, Catheter tip thrombus, Catheter sleeve, Patient-reported outcome measure