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

P

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

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.

Trial contacts and locations

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Central trial contact

Houpu Yang, MD

Data sourced from clinicaltrials.gov

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