Clinical trial NCT02492477: TOP-TRIAL Safety of Not Flushing Non-used PORT-A-CATH® in Cancer Patients
Official title: TOP-TRIAL The Safety of Not Flushing the Non-used PORT-A-CATH® in Cancer Patients - a Prospective, Two-arm Phase I Trial, Pilot Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Adjuvant Chemotherapy
Solid Tumours
Port-A-Cath
Lead sponsor: Krankenhaus Barmherzige Schwestern Linz
Sponsor class: OTHER
First posted: 2015-07-08
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The benefits and risks of flushing or not flushing the non-used PORT-A-CATH® in cancer patients and the time interval of eventual PORT-A-CATH® flushing are currently unknown. The manufacturers of PORT-A-CATH® recommend regular flushings every 4 weeks. In clinical practice, the intervals are usually at least three months. Regular flushing might lead to a decreased risk of PORT-A-CATH® thrombosis, but may also lead to an increased infection or thrombosis rate and patients discomfort. Therefore, this study investigates the safety of not flushing the PORT-A-CATH® for 6 or 12 months.

Detailed description: Currently it is unknown if flushing a non-used PORT-A-CATH® every 4 weeks is a valid strategy to preserve its functioning. Even more, decision to keep the PORT-A-CATH® after completion of adjuvant therapy cannot be based on profound patient information as there exist hardly any data regarding PORT-A-CATH® related complications of non-used PORT-A-CATH®.

The proposed prospective, two arm trial aims to investigate if no flushing of a non-used PORT-A-CATH® over a period of one year has equal PORT-A-CATH® related complications compared to flushing the PORT-A-CATH® every 4 weeks.

The proposed trial also aims to examine the frequencies of PORT-A-CATH® related complications in non-used PORT-A-CATH®. The authors put up the hypothesis that there will be fewer port-a-cath related infections in the experimental arms compared to the infection rate mentioned in the literature up to 27 %, since the puncture of the PORT-A-CATH® and the administration of fluids are the main causes of infection.

Eligibility criteria: Inclusion Criteria:

* Cancer patients in curative setting, with port a cath Implantation for systemic chemotherapy, including neo-adjuvant and adjuvant chemo-immunotherapy and supportive therapy (e.g. parenteral Nutrition)
* Completion of curative Treatment with port a cath indication, operation included, regardless of a non-intravenous (subcutaneous or oral) given therapy (endocrine therapy, chemo-immunotherapy, radiotherapy)
* patients with pectoral port a cath systems
* No port a cath associated complications during curative therapy such as investigated events: persistent malfunction, thrombosis, infection of the port-a-cath (to puncture the port a cath under X-ray control is allowed except it results in diangosis of persistent malfunction)
* No therapeutic anticoagulant therapy (phenprocoumon/Marcoumar®, heparin)
* No evidence of metastatic disease
* ≥18 years
* Willing to participate

Exclusion Criteria:

* No signed informed consent
* Patients with port a cath systems other than pectoral port a cath systems (e.g. forearm port a cath System)
* Unable to attend control timepoints
* Use of the port-a-cath after the above defined curative treatment (within the investigational period)
* Willing to explant the port-a-cath
* Willing to become pregnant within one year after adjuvant treatment
* Patient with heparin-induced Thrombocytopenia (HIT)

Primary outcomes:
measure: incidences of PORT-A-CATH® related events (persistent malfunction, thrombosis, infection)
timeFrame: 6 or 12 months
Secondary outcomes:
measure: incidences of restoration of PORT-A-CATH® function by alteplase
timeFrame: 6 or 12 months
measure: rate of necessary PORT-A-CATH® removal
timeFrame: 6 or 12 months
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Krankenhaus der Barmherzigen Schwerstern Linz Betriebsges.m.b.H.
state: Upper Austria
Study officials:
affiliation: BHSL, Abt. für Gynäkologie
name: Judith Lafleur, OA Dr.
role: PRINCIPAL_INVESTIGATOR
References: