PREMO Study: to Investigate Port REMoval Outcomes

Not Applicable

Completed

• Conditions: Cystic Fibrosis; Neoplasms
• Interventions: 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

• Registration Number: NCT03948958
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief 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.

Study Timeline

• Study First Submitted: 2019-05-10
• Study First Submitted QC: 2019-05-13
• Study First Posted: 2019-05-14
• Study Start: 2019-06-28
• Primary Completion: 2022-07-08
• Study Completion: 2022-07-08
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-11
• Last Update Posted: 2022-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
TIVAD function	during the 1 day of TIVAD removal, before the linogram	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.

Secondary Outcome Measures

Name	Time	Method
Catheter tip position visualization by fluoroscopy	during the 1 day of TIVAD removal, just before the linogram	The patient will be positioned in a nearly standing position with chest elevation of 17°
Port chamber filling, sleeve formation, sleeve extend, catheter tip thrombosis and damage in port chamber or catheter trajectory	during the 1 day of TIVAD removal	will be visualised by linogram (digital substraction angiography)
Catheter tip and port chamber culture	during the 1 day of TIVAD removal (following TIVAD removal)	microbial culture

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium