PREMO Study: to Investigate Port REMoval Outcomes (PREMO)
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|ClinicalTrials.gov Identifier: NCT03948958|
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : May 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms Cystic Fibrosis||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||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Trial to Assess Functional, Microbial, Radiological and Patient Reported Outcomes at Totally Implantable Venous Access Device (Port) Removal (PREMO Study)|
|Actual Study Start Date :||June 28, 2019|
|Estimated Primary Completion Date :||November 1, 2020|
|Estimated Study Completion Date :||November 1, 2020|
Experimental: TIVAD evaluation
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
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.
- TIVAD function [ Time Frame: 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.
- Catheter tip position visualization by fluoroscopy [ Time Frame: 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 [ Time Frame: during the 1 day of TIVAD removal ]will be visualised by linogram (digital substraction angiography)
- Catheter tip and port chamber culture [ Time Frame: during the 1 day of TIVAD removal (following TIVAD removal) ]microbial culture
- Patient-reported outcome measure [ Time Frame: during the 1 day of TIVAD removal ]Patient's experiences will be collected by means of the Leuven Patient Reported Experiences at Port removal (Leuven PREP) questionnaire a self-reported 25-items questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948958
|Contact: Marguerite Stas, MD, PhD||+3216346839 ext email@example.com|
|Contact: Martine Jérôme, MSc, RN||+3216346764 ext firstname.lastname@example.org|
|University Hospitals Leuven||Recruiting|
|Leuven, Belgium, 3000|
|Contact: Martine Jérôme, MSc RN +3216346764 email@example.com|
|Principal Investigator:||Marguerite Stas, MD, PhD||Universitaire Ziekenhuizen Leuven|