Can ILR Reduce the Risk of Arm Lymphedema?

NCT ID: NCT05742945

Last Updated: 2024-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-14

Study Completion Date

2028-08-31

Brief Summary

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Breast cancer-related lymphedema (BCRL) is a debilitating, usually lifelong burden for breast cancer survivors. For the breast cancer patients receiving axillary lymph node dissection (ALND), the likelihood of BCRL is about 20%. Lymphatico-venous anastomosis (LVA) has been accepted as a method of treating extremity lymphedema. A few studies have mentioned the prophylactic effect of LVA on BCRL. However, there is still lack of a large-scale randomized controlled trial to corroborate its efficacy. Therefore, the goal of this study is to conduct a prospective randomized controlled trial to evaluate if immediate lymphatic reconstruction (ILR) with LVA could have a clinically significant effect on the reduction of BCRL occurrence.

Detailed Description

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Conditions

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Breast Cancer Lymphedema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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ILR

Breast cancer patients receiving axillary lymph node dissection and immediate lymphatic reconstruction

Group Type EXPERIMENTAL

Immediate lymphatic reconstruction

Intervention Type PROCEDURE

Breast cancer patients receive axillary lymph node dissection and immediate lymphatic reconstruction

non-ILR

Breast cancer patients receiving only axillary lymph node dissection

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Immediate lymphatic reconstruction

Breast cancer patients receive axillary lymph node dissection and immediate lymphatic reconstruction

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Female patients with unilateral breast cancer
2. Going to receive axillary lymph node dissection, or sentinel lymph node biopsy but being highly suspected of axillary metastasis preoperatively

Exclusion Criteria

1. Had received axillary lymph node dissection
2. Going to receive bilateral axillary lymph node dissections
3. Already have arm lymphedema
4. Allergy to the dye used intraoperatively
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hao-Chih Dai, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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202207198RINB

Identifier Type: -

Identifier Source: org_study_id

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