Immediate Axillary Plasty With a Pedicled Muscle Flap for Breast Cancer Related Lymphedema Prevention

Peking University

Status: Unknown

Conditions: Breast Neoplasm; Lymphedema

Treatments: Procedure: Immediate Axillary Plasty

Study type: Interventional

Funder types: Other

Identifiers

NCT02318615

PKUPHBR001 (Other Identifier)

AxLD

Details and patient eligibility

About

The purpose of this comparable cohort study is to evaluate the efficacy and safety of immediate axillary plasty with pedicled partial Latissimus Dorsi muscle flap for lymphedema prevention in breast cancer patients who are undergoing axillary dissection.

Full description

Upper limb lymphedema is the main complication of axillary dissection. It is estimated that as many as 50% of patients undergoing lymph node dissection go on to develop lymphedema, with significantly decreased quality of life with frequent infections, decreased range of motion, and a cosmetic deformity. The treatment of lymphedema was be frustrated by technical difficulties and gave rise to a heavy budget burden. Some retrospective studies revealed that immediate and delayed breast reconstruction with lattismus dorsi flap brought unexpected relief to the upper limb lymphedema. The current study was composed to assess whether transferring a pedicled partial latissimus dorsi muscle flap to the axilla would prevent the occurrence of post-mastectomy lymphedema.

This prospectively designed cohort study have two parallel arms. Patients undergoing axillary dissection would be recruited to one of the two groups, according their own preference.

Enrollment: 450 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing axillary lymph node dissection

Exclusion criteria

• Prior iplateral upper limb edema
• Plan for breast or axillary reconstruction
• The thoracodorsal vessel damage
• Muscle flap volume too low

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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450 participants in 2 patient groups

Immediate Axillary Plasty

Experimental group

Description:

Immediate Axillary Plasty ：After axillary lymph node dissection, a pedicled flap named Partial Latissimus Dorsi Muscle Flap is filled in the cavity of axilla, and fixed around the axillary vessels.

Treatment:

Procedure: Immediate Axillary Plasty

Education

No Intervention group

Description:

Education：After surgery, education on the prevention of lymphedema. In patients suffering with upper limb lymphedema during follow-up, any treatment except axillary or breast reconstruction can be used.