The Effectiveness of Lymphatic Bypass Supermicrosurgery

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer Related Lymphedema; Lymphedema Arm
• Interventions: Procedure: Lymphatic Bypass Supermicrosurgery

• Registration Number: NCT05682885
• Lead Sponsor: Dharmais National Cancer Center Hospital

Brief Summary

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).

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 Timeline

• Study Start: 2022-10-06
• Study First Submitted: 2022-11-22
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-19
• Last Update Posted: 2025-01-22
• Primary Completion: 2027-10-31
• Study Completion: 2027-11-18

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Axillary lymph node dissection with LBS	Lymphatic Bypass Supermicrosurgery	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.

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of BCRL	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 Outcome Measures

Name	Time	Method
BCRL and SCL progression-free survival rate	1 year	Percentage of subjects who do not progress to subclinical lymphedema or lymphedema during the research.
Quality of life lymphedema	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.
Collateral lymphatic pathway	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.

Trial Locations

Locations (1)

Dharmais National Cancer Center Hospital; 🇮🇩 Jakarta, Indonesia