Evaluation of Impact of Sandostatin® Injection Before Axillary Clearance on Lymphocele Formation

Study Overview
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Brief Summary
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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

Official Title
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Evaluation of Impact of Sandostatin® Injection Before Axillary Clearance on Lymphocele Formation In Patients With Breast Cancer

Conditions
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Breast Cancer, Lymphocele

Intervention / Treatment
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* Procedure: Injection of sandostatine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: A phase II prospective, single-center, non-randomized study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sandostatine<br>Injection of Sandostatine | Procedure: Injection of sandostatine<br>* Intramuscular injection of sandostatin 30 mg 3 days before surgery<br>* Other names: Octreotide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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®. | The frequency of occurrence of a lymphocele requiring at least one evacuation puncture. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the volume of the punctures | Determined by the volume of the punctures carried out | 6 months | 
| Evaluation of the cost of this treatment | Determined by the data recovered from the Health Insurance | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, axillary clearance, lymphocele