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OpenTrials
Completed

NCT Number: NCT01146158

Axillary Reverse Mapping for Breast Carcinomas

Distinct arm from breast axillary dissection (AD), or axillary reverse mapping (ARM), involves retrieving all breast related nodes while leaving intact the main lymphatic drainage chain of the upper limb. This represents a new surgical technique that is the focus of recent surgical interest.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hospital European Georges Pompidou

Paris, 75015, France

About this study

Distinct arm from breast axillary dissection (AD), or axillary reverse mapping (ARM), involves retrieving all breast related nodes while leaving intact the main lymphatic drainage chain of the upper limb. This represents a new surgical technique that is the focus of recent surgical interest. The assumption is that the sentinel node (SN) of the upper limb is different from the SN of the breast and that it is uninvolved after metastatic involvement of the axillary nodes in relation to the breast. During the ARM procedure, it is necessary to use an injection of a lymphatic tracer into the upper limb in order to visualize the lymphatic arm drainage.The ultimate goal for ARM procedure is to reduce the rate of lymphedema in N+ patients requiring an AD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Indication for formal Axillary Dissection (AD)
  • N0 patient with a large tumor: T3
  • N1 patient
  • N2 patient with axillary imaging showing limited node involvement(1-4N+).
  • Secondary AD after a positive sentinel node ( pN1, pN1(mi))
  • AD after préopérative chemotherapy in a patient initially N+.
  • Age between 18 and 70
  • Signature of the consent form.
  • Patients beneficiary of the Social Security

Exclusion criteria

  • N0 patient with an indication of Sentinel Node biopsy
  • N2 patient with axillary imaging showing suspected node involvement >4N+.
  • N3 patient
  • Age over 70
  • Pregnancy
  • Blue dye allergy
  • Mentally deficient patient

Treatment and study plan

Axillary dissection for breast carcinomas

Procedure

surgery Axillary dissection

Other names: surgery Axillary dissection

Primary outcomes

  1. Success of the principal objectives is qualified as finding one or more radioactive node in zone D

    Time frame: 1 day

    Zone D is the area lateral to the lateral thoracic vein and extending from the second intercostobrachial nerve to the axillary vein.

    If all radioactive nodes are found below the second intercostobrachial nerve (Zone C, A) or medial to the lateral thoracic vein (Zone A, B) this qualifies a failure of the main objective

Secondary outcomes

  1. Evaluate the incidence of metastatic or micro-metastatic disease within the "SENTIBRAS " node

    Time frame: 15 days

    Evaluate the incidence of metastatic or micro-metastatic disease within

  2. Evaluate the correlation between clinical and histological results

    Time frame: 15 days

    Evaluate the correlation between clinical and histological results

  3. Evaluate the morbidity associated with Axillary Dissection.

    Time frame: 1 year, 2 years and 5 years

    Evaluate the morbidity associated with Axillary Dissection.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Individualisation of the Lymphatic Arm Drainage During Axillary Dissection for Breast Carcinomas.

Acronym: SENTIBRAS

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 17, 2010
Registry last updated
Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.