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

NCT ID: NCT03791736

Last Updated: 2022-07-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-06
• Study Completion Date: 2018-07-06

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

Conditions

Breast Cancer; Lymphocele

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Sandostatine

Injection of Sandostatine

Group Type: EXPERIMENTAL

Injection of sandostatine

Intervention Type: PROCEDURE

Intramuscular injection of sandostatin 30 mg 3 days before surgery

Interventions

Injection of sandostatine

Intramuscular injection of sandostatin 30 mg 3 days before surgery

Intervention Type: PROCEDURE

Other Intervention Names

Octreotide

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Cancerologie de l'Ouest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

EMMANUELLE MARTIN, MD

Role: STUDY_DIRECTOR

INSTITUT DE CANCEROLOGIE DE L'OUEST

Other Identifiers

2015-03

Identifier Type: -

Identifier Source: org_study_id