NCT02318615

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 17, 2014

Completed
12 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

2.7 years

First QC Date

December 11, 2014

Last Update Submit

November 19, 2015

Conditions

LymphedemaBreast Neoplasm

Keywords

Breast NeoplasmLymphedemaAutologous flaplattismus dorsi flap

Outcome Measures

Primary Outcomes (1)

  • Incidence of lymphedema and/or severity of lymphedema

    Up to 3 years

Secondary Outcomes (3)

  • Shoulder Mobility

    up to 3 years

  • Postoperation seroma

    up to one month

  • Acute Upper limb thrombosis

    Up to one month

Study Arms (2)

Immediate Axillary Plasty

EXPERIMENTAL

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

Education

NO INTERVENTION

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.

Interventions

Immediate Axillary PlastyPROCEDURE

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

Immediate Axillary Plasty

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing axillary lymph node dissection

You may not qualify if:

  • Prior iplateral upper limb edema
  • Plan for breast or axillary reconstruction
  • The thoracodorsal vessel damage
  • Muscle flap volume too low

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

LymphedemaBreast Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Houpu Yang, MD

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Houpu Yang, MD

CONTACT

86-10-88324010yanghoupu@pkuph.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2014

First Posted

December 17, 2014

Study Start

December 1, 2015

Primary Completion

August 1, 2018

Study Completion

August 1, 2020

Last Updated

November 20, 2015

Record last verified: 2015-11