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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A01822-47 | Other Identifier | ID-RCB number |
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Changes of the standard adjuvant treatment which does not allow an iterative PICC placement
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
| C. R. Bard | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iterative PICC placement | Experimental | New PICC placement at each chemotherapy cycle (removed after treatment administration) |
|
| Long term implantable device | Active Comparator | Port-a-cath inserted prio first chemotherapy cycle and maintained throughout the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iterative PICC placement | Procedure | Intervention is the catheterisation strategy (not the device) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare complication rate for iterative placement (PICC) versus long term placement (PAC). | 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. | 6 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate for each strategy | 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 | 6 months after randomization |
| Description of failure causes for each strategy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hervé ROSAY, MD | Centre Leon Berard | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Julien GAUTIER | Lyon | 69008 | France |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Long term PAC placement | Procedure | Intervention is the catheterisation strategy (not the device) |
|
Causes of failures will be described |
| 6 months after randomization |
| Level of pain for each strategy | Level of pain will be assessed with the verbal scale rated from 0 to 10 | At Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1 |
| Quality of Life in both arms | Quality of Life will be assessed with the EQ-5D questionnaire | At Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1 |
| D017437 |
| Skin and Connective Tissue Diseases |