PREMO Study: to Investigate Port REMoval Outcomes

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Neoplasms; Cystic Fibrosis

Treatments: Other: Macroscopic evaluation of the port chamber and catheter; Other: Catheter-related colonization; Other: Catheter tip location, thrombus, sleeve and device damage visualization; Other: Evaluation of the catheter function; Other: patient-reported outcome measures (PROM) related to the presence of the TIVAD

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03948958

S62321

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

TIVAD evaluation

Experimental group

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

Treatment:

Other: Macroscopic evaluation of the port chamber and catheter

Other: Evaluation of the catheter function

Other: Catheter-related colonization

Other: Catheter tip location, thrombus, sleeve and device damage visualization

Other: patient-reported outcome measures (PROM) related to the presence of the TIVAD