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

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ClinicalTrials.gov Identifier: NCT02318615
Recruitment Status : Not yet recruiting
First Posted : December 17, 2014
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lymphedema Breast Neoplasm Procedure: Immediate Axillary Plasty Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : December 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Procedure: Immediate Axillary Plasty
Immediate Axillary Plasty would be performed to reduce the formation of scar in the axilla.

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.



Primary Outcome Measures :
  1. Incidence of lymphedema and/or severity of lymphedema [ Time Frame: Up to 3 years ]

Secondary Outcome Measures :
  1. Shoulder Mobility [ Time Frame: up to 3 years ]
    Shoulder Mobility: the difference between baseline and postoperation,including flexion extension rotation abduction and adduction.

  2. Postoperation seroma [ Time Frame: up to one month ]
    The incidence of axilla and donor site

  3. Acute Upper limb thrombosis [ Time Frame: Up to one month ]
    The incidence of thrombosis linked to postoperation immobility



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02318615


Contacts
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Contact: Houpu Yang, MD 86-10-88324010 yanghoupu@pkuph.edu.cn

Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: Houpu Yang, MD Peking University People's Hospital

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Responsible Party: Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT02318615     History of Changes
Other Study ID Numbers: AxLD
PKUPHBR001 ( Other Identifier: PKUPH )
First Posted: December 17, 2014    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015
Keywords provided by Peking University People's Hospital:
Breast Neoplasm
Lymphedema
Autologous flap
lattismus dorsi flap
Additional relevant MeSH terms:
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Breast Neoplasms
Lymphedema
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Lymphatic Diseases