PICC placement will be performed according to standard practice (Safe Insertion of PICC protocol (SIP2) steps).

The catheter will be secured by the Statlock system. Cyanoacrylate glue will be applied on the catheter exit point in accordance with the instructions for use.

A transparent dressing will be applied, with a compress in the event of bleeding.

PICC placement will be performed according to standard practice (Safe Insertion of PICC protocol (SIP2) steps).

The catheter will be secured by the Statlock system. A transparent dressing will be applied, with a compress in the event of bleeding.

The wound must be positioned in a horizontal plane, and the glueapplied uniformly overhanging the wound. Cyanoacrylate glue is contraindicated when adhesion cannot be achieved.

Cyanoacrylate glue should be applied in accordance with the instructions for use.

Wound-closing properties are only fully achieved once the first layer has fully polymerized. This depends on skin type, skin hydration and ambient humidity. If a second layer is applied, the polymerization time is extended accordingly.

Cyanoacrylate glue application

Grégoire WALLON, MD

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.

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.

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).

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.

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.

Success is defined by the possibility of using a dressing without compression at application (at hour 0), i.e. without bleeding after the defined compression time.

Proportion of patients requiring dressing changes at the CLB within one hour of the end of procedure

Proportion of patients requiring dressing changes (home nursing/home care/home hospitalization) in the medium term (day 8)

Proportion of patients requiring dressing changes (home nursing/home care/home hospitalization) in the medium term (day 30)

Incidence of PICC removal for any reason within 30 days following placement.

Incidence of PICC-related complications (infection, thrombotic event, obstruction, displacement requiring PICC replacement or not) in the 30 days following placement.

Centre Leon Berard

PICC is initially routine insertion at the time of admission of hospice-palliative care unit

PICC is inserted if 3 or more times of IV insertion trial per day is required for IV access

comparisons of the safety, efficacy, and patient-perceived satisfaction between the initially routine PICC insertion group (routine PICC group) and general IV access group (general IV group)

peripherally inserted central catheter (PICC)

Kwonoh Park, MD, PhD

To establish the IV access strategy for terminally ill cancer patients, using comparisons of the safety, efficacy, and patient-perceived satisfaction between the initially routine PICC insertion group (routine PICC group) and general IV access group (optional PICC group).

Reliable intravenous (IV) access is an important issue in terminally ill cancer patients, however, they have limited or no peripheral venous access due to edema or long period of IV therapy. Thus, intravenous access has been provided by Central venous catheter (CVC).

There are some options for applying CVC in cancer patients; subclavian venous catheter (SVC), chemo-port (CP), and the peripherally inserted central catheter (PICC).

When considering the characteristics of terminally ill cancer patients, such as poor general condition and a limited period of survival, PICC could be a safe and effective method for intravenous access.

There are two previous studies concerned about PICC study in terminally ill cancer patients. They showed that PICC might be overall safe and efficient in terminally ill cancer patients. However, these studies did not evaluate superiority of PICC insertion compared to no insertion and the appropriate time for PICC insertion due to limitation of their design, such as retrospective or single-arm observational study. Thus, strategies of PICC insertion for IV access in terminally ill cancer patients have not been determined until now.

Considering the favorable results of PICC insertion in previous studies and limited survival time of terminally ill cancer patients, the investigator postulated that routine PICC insertion at the time of admission for terminal care would be effective for IV access.

Thus, the investigator assumed that initially routine PICC insertion would be non-inferior in maintenance success rate / and complication rate compared to general IV access. In addition, it would be superior in patient-perceived satisfaction. The inveistigator will undertake a randomized phase II study to confirm the hypothesis.

Prospective, Single institution, Open-label, Randomized, Phase 2

Comparison Between Initial Routine PICC and General IV Access in Terminally Ill Cancer Patients

Comparison of Safety, Efficacy, and Patient-perceived Satisfaction Between Initial Routine Peripherally Inserted Central Catheters Insertion and General Intravenous Access in Terminally Ill Cancer Patients: A Randomized Phase II Study

rate of successful PICC maintenance until death or discharge/transfer

rate of any complication which is related with PICC

rate of premature removal such as self-removal or CRBSI before death or discharge

procedure-related distress during insertion of PICC

patient perceived comfort and convenience ("How do participants feel comfort and convenience about the IV access?" at 3th - 7th days after enrollment

Investigator evaluate the colonization of PICC using tip culture at the time of removal

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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.	NCT05944900	Cancer	Cyanoacrylate g...	18 Years -	Centre Leon Berard
Comparison Between Initial Routine PICC and General IV Access in Terminally Ill Cancer Patients	NCT03299868	Peripherally In... Intravenous Acc...	peripherally in...	18 Years -	Pusan National University Yangsan Hospital
Comparison Between Initial Routine PICC and General IV Access in Terminally Ill Cancer Patients	NCT03299868	Peripherally In... Intravenous Acc...	peripherally in...	18 Years -	Pusan National University Yangsan Hospital

Spots Global Cancer Trial Database for peripherally inserted central catheter (picc)