NCT04687956

Brief Summary

Lymphedema refers to edema caused by insufficient drainage of interstitial fluid through the lymphatic circulation system. It occurs mainly in the upper and lower extremities and causes chronic inflammation, and finally fibrous adipose tissue is replaced. In this study, the'LYMPHA' (Lymphatic microsurgical preventing healing approach) procedure, which connects lymphatic vessels drained from the arm to the side branches of the axillary vein, contributes to the prevention of lymphedema in patients undergoing axillary lymph node dissection for breast cancer. Investigator aim to help patients' quality of life by prospectively analyzing the effects and applying them to clinical practice, reducing the incidence of lymphedema.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Feb 2021Dec 2027

First Submitted

Initial submission to the registry

November 29, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 29, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

October 11, 2023

Status Verified

October 1, 2023

Enrollment Period

6.9 years

First QC Date

November 29, 2020

Last Update Submit

October 9, 2023

Conditions

LymphedemaMastectomyBreast Cancer

Outcome Measures

Primary Outcomes (1)

  • Incidence of lymphedema

    To compare the incidence of lymphedema assessed by UEL index and lymphoscintigraphy at 2 years after the surgery.

    2 years after surgery

Secondary Outcomes (5)

  • UEL index

    2 years after surgery

  • Changes in Lymphoscintigraphy

    2 years after surgery

  • Incidence of lymphedema

    5 years after surgery

  • 5-year recurrence rate

    5 years after surgery

  • 5-year overall survival rate

    5 years after surgery

Study Arms (2)

LYMPHA

EXPERIMENTAL

LYMPHA procedure is performed in which the lymphatic vessels drained from the arm and the axillary vein are micro-bonded to the side branches.

Procedure: LYMPHA

Control

ACTIVE COMPARATOR

No LYMPHA procedure is performed

Procedure: control

Interventions

LYMPHAPROCEDURE

Axillary reverse mapping is performed before surgery, axillary lymph node resection is performed, and 'LYMPHA' (Lymphatic microsurgical preventing healing approach) is performed, and the surgery is terminated. Subsequently, the occurrence of lymphedema is followed up.

LYMPHA
controlPROCEDURE

In the control group, axillary lymph node resection is performed and the surgery is terminated without additional procedures. Subsequently, the occurrence of lymphedema is followed up.

Control

Eligibility Criteria

Age19 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFemale patient
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 19 years old
  • Patients who are expected to undergo surgery under the diagnosis of breast cancer, and are determined to undergo axillary lymph node dissection before surgery.

You may not qualify if:

  • Patients with vascular and lymph-related diseases
  • Patients with a history of surgical treatment or trauma to both arms and axillary
  • Patients with a history of receiving radiation treatment in both arms, chest, and axilla
  • Patients with confirmed systemic metastasis with stage 4 breast cancer
  • Pregnant and lactating patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam Severance Hospital, Yonsei University College of Medicine

Seoul, 06273, South Korea

RECRUITING

MeSH Terms

Conditions

LymphedemaBreast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Soong June Bae, M.D.

CONTACT

82-2-2019-4401mission815815@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 29, 2020

First Posted

December 29, 2020

Study Start

February 1, 2021

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

October 11, 2023

Record last verified: 2023-10

Locations

KR(1)