Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05682885

The Effectiveness of Lymphatic Bypass Supermicrosurgery

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Breast Cancer Related Lymphedema Breast Cancer Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Lymphedema Arm Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dharmais National Cancer Center Hospital

Jakarta, Jakarta Special Capital Region, 11420, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lymphatic Bypass Supermicrosurgery

Procedure

Axillary Lymph Node Dissection with Lymphatic Bypass Supermicrosurgery

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

Dharmais National Cancer Center Hospital

Other Gov

Registry information

Official study title

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

Acronym: ELYBS

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jan 12, 2023
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.