The Effectiveness of Lymphatic Bypass Supermicrosurgery (ELYBS)

January 19, 2025 updated by: Bayu Brahma, Dharmais National Cancer Center Hospital

The Effectiveness of Lymphatic Bypass Supermicrosurgery for Primary Lymphedema Prevention After Breast Cancer Axillary Lymph Node Dissection: a Randomized Controlled Study

This study evaluate the effectiveness of lymphatic bypass supermicrosurgery (LBS) and axillary lymph node dissection (ALND) compare to ALND alone to prevent breast cancer treatment-related lymphedema (BCRL).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

In the intervention group, LBS was performed after ALND with the intima-to-intima coaptation using the supermicrosurgery technique. The anastomosis is done between the afferent lymphatic vessel to the recipient's vein, or if possible, from the afferent to the efferent lymphatic vessel. The upper extremity lymphedema (UEL) index and indocyanine green (ICG) lymphography are utilized to evaluate the development of lymphedema.

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Jakarta, Indonesia, 11420
        • Dharmais National Cancer Center Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Breast cancer patient aged >18 years old
  • Breast cancer patient with clinically ALNs metastases (cN1 or cN2).
  • Breast cancer patient with no clinical metastasis and tumor size ≥5cm or no sentinel lymph node biopsy facility in the hospital.
  • Any breast cancer patients that receive neoadjuvant systemic therapy.

Exclusion Criteria:

  • Stage IV breast cancer patients who do not show clinical and radiological improvement after primary systemic therapy.
  • Breast cancer patients with previous surgeries such as mastectomy, axillary lymph node biopsy, sentinel lymph node biopsy (SLNB), and ALND.
  • Breast cancer patients with prior breast, chest wall, axillary, or neck radiotherapy.
  • Breast cancer patients with preoperative lymphatic system abnormality detected by ICG lymphography.
  • Breast cancer patients with iodine allergy, asthma, decreased kidney function, pregnancy, and lactation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Axillary lymph node dissection with LBS
70 subjects will be needed for each group. A standard mastectomy or lumpectomy incision is made and ALND will be done in the same incision. The lymphatic vessels and lymph nodes will be resected using a near-infrared (NIR) camera. To locate lymphatic vessels, a microscope with ICG lymphography navigation is employed. LBS was performed by making intima-to-intima anastomosis between the afferent lymphatic vessels and the recipient's veins, or to the efferent lymphatic vessels. The anastomosis patency will be assessed by observing the ICG fluorescent flow. After surgery, follow-up will be done every 2 months and every 3 months in the second year. UEL index, ICG lymphography, and quality of life evaluation will be done. The cumulative incidence of BCRL, the free survival time of BCRL, and subclinical lymphedema (SCL) progression will be reported descriptively. BCRL risk factors and collateral lymphatic pathway will be observed as well.
Procedure: Lymphatic Bypass Supermicrosurgery
Axillary Lymph Node Dissection with Lymphatic Bypass Supermicrosurgery
No Intervention: Axillary lymph node dissection without LBS
70 subjects will be needed for each group. A standard mastectomy or lumpectomy incision is made and ALND will be done in the same incision. After primary breast cancer removal, a standard ALND level I, II, and if necessary, level III is performed. After surgery, follow-up will be done every 2 months and every 3 months in the second year. History taking, physical examination, radiology and histopathology examination, UEL index, and ICG lymphography evaluation will be done during follow-up. Each subject will complete the lymphedema quality of life questionnaire. The cumulative incidence of BCRL, the free survival time of BCRL, and SCL progression will be reported descriptively. BCRL risk factors and collateral lymphatic pathway will be observed as well.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of BCRL
Time Frame: 1 year

BCRL definition:

Post operation subject condition with presence of minimum DB 2 with one or both symptoms (swelling, heaviness), and increment of UEL index >10% compared to pre operation

OR

Post operation subject condition with presence of ≥ DB 2 with minimum area 30% in one arm region in one of the arm lymphatic pathway (anterior or posterior), without presence of symptoms (swelling or heaviness), and increment of UEL index >10% compared to pre operation
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BCRL and SCL progression-free survival rate
Time Frame: 1 year
Percentage of subjects who do not progress to subclinical lymphedema or lymphedema during the research.
1 year
Collateral lymphatic pathway
Time Frame: 1 year
The number of lymphatic pathways flow into the region: supraclavicular, internal mammary, and contralateral axillary and supraclavicular nodes based on the ICG lymphography.
1 year
Quality of life lymphedema
Time Frame: 1 year
Assessment of lymphedema quality of life score after the surgery using the lymphedema quality of life score questionnaire that is self-reported by the subjects every 2 months and every 3 months in the second year. Calculation of the lymphedema quality of life score is the summation of the score from each question. The minimum score is 0 and the maximum score is 100. A higher score indicates lower lymphedema quality of life.
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association of body mass index (BMI) with BCRL
Time Frame: 1 year
BMI was calculated by weight (kilograms) and height (centimeters). Categorized based on Asia Pacific classification are overweight (BMI ≥ 23 kg/m^2) and no overweight (BMI < 23 kg/m^2). Measured at one time point.
1 year
Association of number of axillary lymph nodes metastases with BCRL
Time Frame: 1 year
The number of metastases lymph nodes and classified into >3 lymph nodes and ≤3 lymph nodes. Measured at one time point.
1 year
Association of number of taxane chemotherapy with BCRL
Time Frame: 1 year
Taxane chemotherapy data from the subject's medical record and categorized into yes or no. Measured at one time point.
1 year
Association of regional lymph node radiation with BCRL
Time Frame: 1 year
Regional lymph node radiation data from the subject's medical record and categorized into yes or no. Measured at one time point
1 year
Association of axillary fat weight with BCRL
Time Frame: 1 year
Axillary fat weight in grams is taken at the time of surgery. Measured at one time point.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dharmais National Cancer Center Hospital

Investigators

  • Principal Investigator: Bayu Brahma, MD, Dharmais Hospital National Cancer Center, Indonesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2022

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

November 18, 2027

Study Registration Dates

First Submitted

November 22, 2022

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 19, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 227/KEPK/IX/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data collected during the trial will be shared. The researcher provides a methodologically sound proposal. The proposal should be directed to bbrahma@dharmais.co.id. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Time Frame

Beginning 6 months and ending 3 years following article publication.

IPD Sharing Access Criteria

Qualified researchers who have received principal investigator's approval.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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