Wounds and Injuries

All Conditions

Surgical Wound

Internal jugular vein access preferably right, assisted by ultrasound and radioscopy. Catheter: districath®, 8.5 French.

Axillary vein access with single incision, assisted by ultrasound and radioscopy. Catheter: districath®, 8.5 French.

Implantation using percutaneous puncture.

Right internal jugular access.

Left internal jugular access.

Right axillary vein access.

Left axillary vein access.

Bruno S Pignataro

Comparison between internal jugular vein versus via axillary vein with single-incision for placement of implantable ports in cancer patients. Investigators are recruiting 240 patients and randomizing 120 for each arm. Primary outcome is early complications, until 30 days and secondary outcome late complications, between 30 days and 6 months. The follow-up is 12 months.

Prospective and randomized trial comparing internal jugular vein versus via axillary vein with single-incision for placement of implantable ports in cancer patients. Investigators are recruiting 240 patients and randomizing 120 for each arm in a single center study at AC Camargo Cancer Center. Every surgery is assisted by ultrasound and radioscopic and the catheter is districath®, 8.5 French. Clinical assessment will be at 10 days and every 3 months after surgery. Primary outcome is early complications, until 30 days and secondary outcome late complications, between 30 days and 6 months. The follow-up is 12 months.

Comparison between internal jugular vein versus via axillary vein with single-incision for placement of implantable ports in cancer patients. Investigators are recruiting 240 patients and randomizing 120 for each arm. Primary outcome is early complications, until 30 days and secondary outcome late complications, between 30 days and 6 months. The follow-up is 6 months.

Comparison Between Internal Jugular Vein Versus Axillary Vein for Implantable Ports

Internal Jugular Vein Versus Axillary Vein With Single-incision for Implantable Ports: a Prospective and Randomized Study.

Early complications within 30 days during clinical assessment. These outcomes are divided in intra-operative complications, such as pneumothorax, hemothorax, vascular injury, cardiac arrhythmia, hematoma; and post-operative until 30 days complications such as wound infections, catheter related bacteremia, catheter disfunction, catheter related deep venous thrombosis, reservoir extrusion and skin erosion.

Post-operative between 30 days and 6 months complications such as wound infections, catheter related bacteremia, catheter disfunction, catheter related deep venous thrombosis, reservoir extrusion and skin erosion.

AC Camargo Cancer Center

Infections

Heart and Blood Diseases

Symptoms and General Pathology

Digestive System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Thrombosis

Communicable Diseases

Fibrosis

Cystic Fibrosis

Flushing

Catheter-Related Infections

Pancreatic Diseases

Gastrointestinal Diseases

Lung Diseases

Respiratory Tract Diseases

Genetic Diseases, Inborn

Infant, Newborn, Diseases

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

Catheter function will be measured by the CINAS (Catheter injection and aspiration classification)

Evaluation of the catheter function

Catheter tip location, thrombus, sleeve and device damage will be visualized by linogram

Catheter tip location, thrombus, sleeve and device damage visualization

TIVAD colonization will be investigated by microbiological culture of the tip and chamber content

Catheter-related colonization

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.

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

Macroscopic evaluation of the port chamber and catheter will be performed after port removal.

Macroscopic evaluation of the port chamber and catheter

Marguerite Stas, MD, PhD

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.

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.

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)

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

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.

The patient will be positioned in a nearly standing position with chest elevation of 17°

will be visualised by linogram (digital substraction angiography)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Comparison Between Internal Jugular Vein Versus Axillary Vein for Implantable Ports	NCT03512899	Catheter Compli... Cancer	Right internal ... Left internal j... Right axillary ... Left axillary v...	18 Years -	AC Camargo Cancer Center
PREMO Study: to Investigate Port REMoval Outcomes	NCT03948958	Neoplasms Cystic Fibrosis	Evaluation of t... Catheter tip lo... Catheter-relate... patient-reporte... Macroscopic eva...	18 Years -	Universitaire Ziekenhuizen KU Leuven

Spots Global Cancer Trial Database for implantable port