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

Not Applicable

• Conditions: Lymphedema; Breast Neoplasm
• Interventions: Procedure: Immediate Axillary Plasty

• Registration Number: NCT02318615
• Lead Sponsor: Peking University People's Hospital

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2014-12-11
• Study First Submitted QC: 2014-12-11
• Study First Posted: 2014-12-17
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-19
• Last Update Posted: 2015-11-20
• Study Start: 2015-12
• Primary Completion: 2018-08
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 450

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate Axillary Plasty	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.

Primary Outcome Measures

Name	Time	Method
Incidence of lymphedema and/or severity of lymphedema	Up to 3 years

Secondary Outcome Measures

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