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

Overview

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 Title of Study: “The Efficacy and Safety of Immediate Axillary Plasty With Pedicled Partial Latissimus Dorsi Muscle Flap for Lymphedema Prevention in Breast Cancer Patients Who Undergoing Axillary Dissection: a Prospective, Corhort Study”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Prevention
  • Masking: Single (Outcomes Assessor)
• Study Primary Completion Date: August 2018

Detailed 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.

Interventions

• Procedure: Immediate Axillary Plasty
  • Immediate Axillary Plasty would be performed to reduce the formation of scar in the axilla.

Arms, Groups and Cohorts

• Experimental: Immediate Axillary Plasty
  • 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.
• No Intervention: Education
  • 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.

Clinical Trial Outcome Measures

Primary Measures

• Incidence of lymphedema and/or severity of lymphedema
  • Time Frame: Up to 3 years

Secondary Measures

• Shoulder Mobility
  • Time Frame: up to 3 years
  • Shoulder Mobility： the difference between baseline and postoperation，including flexion extension rotation abduction and adduction.
• Postoperation seroma
  • Time Frame: up to one month
  • The incidence of axilla and donor site
• Acute Upper limb thrombosis
  • Time Frame: Up to one month
  • The incidence of thrombosis linked to postoperation immobility

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Peking University People’s Hospital
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Houpu Yang, MD, Principal Investigator, Peking University People’s Hospital
• Overall Contact(s)
  • Houpu Yang, MD, 86-10-88324010, yanghoupu@pkuph.edu.cn