NCT03948958

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Neoplasms
• Cystic Fibrosis

Interventions

Type	Name	Description
OTHER	Evaluation of the catheter function	Catheter function will be measured by the CINAS (Catheter injection and aspiration classification)
OTHER	Catheter tip location, thrombus, sleeve and device damage visualization	Catheter tip location, thrombus, sleeve and device damage will be visualized by linogram
OTHER	Catheter-related colonization	TIVAD colonization will be investigated by microbiological culture of the tip and chamber content
OTHER	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.
OTHER	Macroscopic evaluation of the port chamber and catheter	Macroscopic evaluation of the port chamber and catheter will be performed after port removal.

Timeline

• Start date: 2019-06-28
• Primary completion: 2022-07-08
• Completion: 2022-07-08
• First posted: 2019-05-14
• Last updated: 2022-08-12

Locations

1 site across 1 country: Belgium