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

Lymphedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02318615
• Other study ID #: AxLD
• Secondary ID: PKUPHBR001
• Status: Not yet recruiting
• Phase: N/A
• First received: December 11, 2014
• Last updated: November 19, 2015
• Start date: December 2015
• Est. completion date: August 2020

Study information

• Verified date: November 2015
• Source: Peking University People's Hospital
• Contact: Houpu Yang, MD
• Phone: 86-10-88324010
• Email: yanghoupu[@]pkuph.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: August 2020
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms
• Lymphedema

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of lymphedema and/or severity of lymphedema		Up to 3 years	No
Secondary	Shoulder Mobility	Shoulder Mobility: the difference between baseline and postoperation,including flexion extension rotation abduction and adduction.	up to 3 years	No
Secondary	Postoperation seroma	The incidence of axilla and donor site	up to one month	Yes
Secondary	Acute Upper limb thrombosis	The incidence of thrombosis linked to postoperation immobility	Up to one month	No