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

Not Applicable

Terminated

• Conditions: Breast Cancer; Lymphocele
• Interventions: Procedure: Injection of sandostatine

• Registration Number: NCT03791736
• Lead Sponsor: Institut Cancerologie de l'Ouest

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-06
• Primary Completion: 2018-07-06
• Study Completion: 2018-07-06
• Study First Submitted: 2018-12-31
• Study First Submitted QC: 2018-12-31
• Study First Posted: 2019-01-03
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-26
• Last Update Posted: 2022-07-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sandostatine	Injection of sandostatine	Injection of Sandostatine

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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