Lymphocele
Conditions
Keywords
Axillary lymphocele breast cancer
Brief summary
Injection the day before surgery of 90 mg of Lanreotide LP sub-cutaneously or placebo. Evaluation of the lymphorrhea in the 2 arms of the study
Detailed description
Patients will be recruited among patient refered to our department for a breast cancer and needing an axillary dissection. Enrolled patients will have an injection of Lanreotide or placebo the day before surgery when they arrive in their room. The quantity of lymph in axillary drain will by daily noted until day 4. The patient will be evaluated at D15, D30 and M6 for pain, lymphocele and adverse events. Data will be compared in the 2 groups.
Interventions
DRUGLanreotide LP 90
Lanreotide LP 90
DRUGPlacebo lanreotide
Placebo
Sponsors
Ipsen
University Hospital, Limoges
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult patient (\> 18 years), * Patient undergoing an axillary lymphadenectomy for breast cancer * Patient giving her agreement after being informed
Exclusion criteria
* Patients that don't understand the trial * Type 2 diabetic patients * Cyclosporine treatment * Biliary lithiasis * Pregnancy or breast feeding * Allergic reaction to Lanréotide or same class treatments * Patient included in another trial within the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantity of lymph collected by the drain | D4 post operativly |
Secondary
| Measure | Time frame |
|---|---|
| Prevention of lymphocele | D15, D30 and M6 |
Countries
France
Outcome results
None listed