Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

New PICC placement at each chemotherapy cycle (removed after treatment administration)

Port-a-cath inserted prio first chemotherapy cycle and maintained throughout the study

Intervention is the catheterisation strategy (not the device)

Iterative PICC placement

Long term PAC placement

Hervé ROSAY, MD

Peripherally Inserted Central Catheter (PICC) and port-a-cath (PAC) are the most commonly medical devices used for the administration of chemotherapy.

Placement of these devices via central venous access is sometimes responsible for complications.

The incidence of these complications is correlated with the device holding time.

A strategy of iterative PICC placement could significantly reduce these complications.

Iterative PICC Placement Versus Long Term Device

A Randomized, Multicentre, Comparative Phase III Study of Catheter-related Complications of an Iterative PICC Placement vs a Long-term PAC in Patients With Breast Cancer

Complication rate will be defined by the proportion of patients with at least one of the following complications from the date of randomization to the end of the study:

pneumothorax , hemothorax ,veinous thrombosis, migration or expulsion of the device, fissure or rupture of the catheter, catheter obstruction, extravasation.

Success rate will be determined with the proportion of patients in whom the allocation strategy was conducted until the end of the last cycle of chemotherapy

Level of pain will be assessed with the verbal scale rated from 0 to 10

Quality of Life will be assessed with the EQ-5D questionnaire

Ministry of Health, France

C. R. Bard

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
Iterative PICC Placement Versus Long Term Device	NCT02784730	Breast Cancer	Iterative PICC ... Long term PAC p...	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
Iterative PICC Placement Versus Long Term Device	NCT02784730	Breast Cancer	Iterative PICC ... Long term PAC p...	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

Spots Global Cancer Trial Database for peripherally inserted central catheter