Clinical trial NCT05944900: Study Comparing the Efficacy of Peripherally Inserted Central Catheter (PICC) Placement With the Addition of Cyanoacrylate Glue Versus PICC Placement Alone in Patients With Cancer.
Official title: Randomized, Prospective, Single-center Trial Comparing the Efficacy of Peripherally Inserted Central Catheter (PICC) Placement With the Addition of Cyanoacrylate Glue Versus PICC Placement Alone (Without Glue) in Patients With Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Cancer
Peripherally Inserted Central Catheter (PICC)
Cyanoacrylate Glue
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The randomization (1:1 ratio) will be stratified according to the risk of haemostasis disorders (Presence of at least one risk factor (medication interfering with hemostasis, innate or acquired coagulation disorder, thrombocytopenia) vs. no risk).
Primary purpose: OTHER

Brief summary: This is a randomized, prospective, single-center trial comparing the efficacy of peripherally inserted central catheter (PICC) with the addition of cyanoacrylate glue versus PICC placement alone (without glue) in cancer patients.

Detailed description: Peripherally Inserted Central Catheters (PICCs) are a form of vascular access inserted percutaneously into a vein, usually in the arm, with the distal end at the atrio cava junction (between the superior vena cava and the right atrium). They may be used for a prolonged period or for several days, repeatedly over time (as is the case for certain chemotherapies, parenteral nutrition or long-term intravenous treatments).

Their placement requires aseptic surgical conditions, and a team trained in the procedure, sometimes grouped together in a Vascular Access Unit (UAV).

A PICC is inserted by puncturing the skin and subcutaneous tissues, and securing the catheter with a "Statlock" type stabilizer. The catheter exit point must be covered, at a minimum by a sterile occlusive dressing with a transparent semi-permeable membrane, otherwise referred to as a "transparent dressing".

According to available data, tissue puncture results in bleeding at the puncture site in 25% to 40% of procedures. This bleeding necessitates the application of a sterile compress prior to covering with a transparent dressing. The skin puncture site (also known as the catheter exit point) requires the dressing to be repeated on D1 after insertion.

To sum up:

* If there is no bleeding, there is no need to apply a compress, and the dressing can be changed on D8 after application;
* In the presence of bleeding, a compress is applied and dressing change is mandatory on D1 after application.

PICC placement combined with the use of cyanoacrylate glue would reduce the risk of bleeding, and therefore the need to use of a compress, compared with a standard procedure (without the use of glue).

On this basis, the investigators propose to conduct a randomized, prospective, single-center trial comparing the efficacy of peripherally inserted central catheter (PICC) with the addition of cyanoacrylate glue versus PICC placement alone (without glue) in patients with cancer.

Eligibility criteria: Inclusion Criteria:

* Male or female, 18 years of age or older on the date of signature the informed consent form
* Patient with a histological diagnosis of cancer
* Indication for central line chemotherapy or immunotherapy
* Placement of a single-lumen PICC in the non-tunneled upper limb planned on an ambulatory basis at the Centre
* Planned duration of PICC use \> 30 days
* Dated and signed informed consent, indicating that the patient has been informed of all relevant aspects of the study prior to inclusion;
* Patient covered by a health insurance plan

Exclusion Criteria:

* Patient already included in the study ;
* Patient with known allergy to cyanoacrylates, Violet D\&C or formaldehyde;
* Patient not reachable by telephone ;
* Patient under guardianship;
* Patient does not speak French.

Primary outcomes:
measure: Rate of patients with successful PICC placement
timeFrame: Hour 0
Secondary outcomes:
measure: Proportion of dressing changes within one hour
timeFrame: Up to hour 1
measure: Proportion of dressing changes before day 8
timeFrame: Up to day 8
measure: Proportion of dressing changes before day 30
timeFrame: Up to day 30
measure: Incidence of PICC removal before day 30
timeFrame: Up to day 30
measure: Incidence of PICC-related complications before day 30
timeFrame: Up to day 30
Other outcomes:
measure: Cost analysis in healthcare institutions
timeFrame: Up to day 30
measure: Cost analysis in the community
timeFrame: Up to day 30
measure: Deterministic Sensitivity Analysis
timeFrame: Up to day 30
measure: Probabilistic Sensitivity Analysis
timeFrame: Up to day 30
measure: Organisational impacts
timeFrame: Up to day 30
measure: Success rate of PICC placement strategy
timeFrame: Up to day 30
measure: Total duration of medical interventions
timeFrame: Up to day 30
measure: Assessment of cost of care
timeFrame: Up to day 30
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard
Study officials:
affiliation: Centre Leon Berard
name: Grégoire WALLON, MD
role: PRINCIPAL_INVESTIGATOR
References: