Breast Cancer, Lymphocele
Conditions
Keywords
breast cancer, axillary clearance, lymphocele
Brief summary
The lymphocele is the main early postoperative complication of axillary clearance for breast cancer patients with rates up to 85%. The usual treatment consists of external drainage. However, this method increases the duration of hospitalization. As a result, some practitioners have abandoned drainage, allowing for ambulatory surgery. If this solution makes it possible to reduce the duration of the hospitalizations, it involves iterative punctures of the axillary hollow in case of lymphocele These punctures may be responsible for pain, hematoma or infection of the operative site. To date, no method has proved superior in terms of decreasing the incidence of lymphocele postoperatively axillary clearance. Octreotide (Sandostatin®) is a peptide, one of whose effects is to reduce the inflammation responsible for lymphoceles. The aim of the study is to inject Sandostatin® before surgery, with the aim of reducing the incidence of seroma by 50% after axillary clearance
Interventions
PROCEDUREInjection of sandostatine
Intramuscular injection of sandostatin 30 mg 3 days before surgery
Sponsors
Institut Cancerologie de l'Ouest
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
A phase II prospective, single-center, non-randomized study.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Breast cancer, histologically proven Axillary clearance Elective axillary approach Age ≥ 18 years OMS \< 3 Normal hematological and hepatic blood tests Obtaining the signed written consent of the patient
Exclusion criteria
Axillary clearance with a mastectomy Metastatic disease Disorder precluding understanding of trial information or informed consent Pregnancy, breastfeeding women Patient is willing and able to comply with the protocol for the duration of the study including all scheduled treatment, visits and examinations No severe or uncontrolled diabetes Known hypersensitivity to Octreotide Patient with vitamin B12 deficiency Anticoagulant treatment History of cardiovascular disease Other product being tested in the 4 weeks prior to the start of treatment Patient has valid health insurance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A 50% decrease in the incidence of lymphocele (30% to 15% progression) following axillary clearance of patients operated for breast cancer (excluding mastectomy) pretreated with an injection of Sandostatin®. | 6 months | The frequency of occurrence of a lymphocele requiring at least one evacuation puncture. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the volume of the punctures | 6 months | Determined by the volume of the punctures carried out |
| Evaluation of the cost of this treatment | 6 months | Determined by the data recovered from the Health Insurance |
Outcome results
None listed