The Effectiveness of Lymphatic Bypass Supermicrosurgery

Breast Cancer Related Lymphedema Clinical Trial

— ELYBS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05682885
• Other study ID #: 227/KEPK/IX/2022
• Status: Recruiting
• Phase: N/A
• Start date: October 6, 2022
• Est. completion date: July 2024

Study information

• Verified date: October 2023
• Source: Dharmais National Cancer Center Hospital
• Contact: Bayu Brahma, MD
• Phone: +62215681570
• Email: bbrahma[@]dharmais.co.id
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Breast Cancer Related Lymphedema
• Breast Neoplasms
• Lymphedema
• Lymphedema Arm

Intervention

Procedure:
• Lymphatic Bypass Supermicrosurgery
Axillary Lymph Node Dissection with Lymphatic Bypass Supermicrosurgery

Locations

Country	Name	City	State
Indonesia	Dharmais National Cancer Center Hospital	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Dharmais National Cancer Center Hospital

Country where clinical trial is conducted

Indonesia, 

References & Publications (9)

Akita S, Nakamura R, Yamamoto N, Tokumoto H, Ishigaki T, Yamaji Y, Sasahara Y, Kubota Y, Mitsukawa N, Satoh K. Early Detection of Lymphatic Disorder and Treatment for Lymphedema following Breast Cancer. Plast Reconstr Surg. 2016 Aug;138(2):192e-202e. doi: 10.1097/PRS.0000000000002337. — View Citation

Brahma B, Putri RI, Karsono R, Andinata B, Gautama W, Sari L, Haryono SJ. The predictive value of methylene blue dye as a single technique in breast cancer sentinel node biopsy: a study from Dharmais Cancer Hospital. World J Surg Oncol. 2017 Feb 7;15(1):41. doi: 10.1186/s12957-017-1113-8. — View Citation

Brahma B, Putri RI, Reuwpassa JO, Tuti Y, Alifian MF, Sofyan RF, Iskandar I, Yamamoto T. Lymphaticovenular Anastomosis in Breast Cancer Treatment-Related Lymphedema: A Short-Term Clinicopathological Analysis from Indonesia. J Reconstr Microsurg. 2021 Oct;37(8):643-654. doi: 10.1055/s-0041-1723940. Epub 2021 Mar 1. — View Citation

Brahma B, Yamamoto T. Breast cancer treatment-related lymphedema (BCRL): An overview of the literature and updates in microsurgery reconstructions. Eur J Surg Oncol. 2019 Jul;45(7):1138-1145. doi: 10.1016/j.ejso.2019.01.004. Epub 2019 Jan 4. — View Citation

Ishiura R, Yamamoto T, Saito T, Mito D, Iida T. Comparison of Lymphovenous Shunt Methods in a Rat Model: Supermicrosurgical Lymphaticovenular Anastomosis versus Microsurgical Lymphaticovenous Implantation. Plast Reconstr Surg. 2017 Jun;139(6):1407-1413. doi: 10.1097/PRS.0000000000003354. — View Citation

Suami H. Anatomical Theories of the Pathophysiology of Cancer-Related Lymphoedema. Cancers (Basel). 2020 May 23;12(5):1338. doi: 10.3390/cancers12051338. — View Citation

Yamamoto T, Narushima M, Yoshimatsu H, Yamamoto N, Kikuchi K, Todokoro T, Iida T, Koshima I. Dynamic Indocyanine Green (ICG) lymphography for breast cancer-related arm lymphedema. Ann Plast Surg. 2014 Dec;73(6):706-9. doi: 10.1097/SAP.0b013e318285875f. — View Citation

Yamamoto T, Yamamoto N, Doi K, Oshima A, Yoshimatsu H, Todokoro T, Ogata F, Mihara M, Narushima M, Iida T, Koshima I. Indocyanine green-enhanced lymphography for upper extremity lymphedema: a novel severity staging system using dermal backflow patterns. Plast Reconstr Surg. 2011 Oct;128(4):941-947. doi: 10.1097/PRS.0b013e3182268cd9. — View Citation

Yamamoto T, Yamamoto N, Hara H, Mihara M, Narushima M, Koshima I. Upper extremity lymphedema index: a simple method for severity evaluation of upper extremity lymphedema. Ann Plast Surg. 2013 Jan;70(1):47-9. doi: 10.1097/SAP.0b013e3182275d23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Association of body mass index (BMI) with BCRL	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
Other	Association of number of axillary lymph nodes metastases with BCRL	The number of metastases lymph nodes and classified into >3 lymph nodes and =3 lymph nodes. Measured at one time point.	1 year
Other	Association of number of taxane chemotherapy with BCRL	Taxane chemotherapy data from the subject's medical record and categorized into yes or no. Measured at one time point.	1 year
Other	Association of regional lymph node radiation with BCRL	Regional lymph node radiation data from the subject's medical record and categorized into yes or no. Measured at one time point	1 year
Other	Association of axillary fat weight with BCRL	Axillary fat weight in grams is taken at the time of surgery. Measured at one time point.	1 year
Primary	Cumulative incidence of BCRL	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	BCRL and SCL progression-free survival rate	Percentage of subjects who do not progress to subclinical lymphedema or lymphedema during the research.	1 year
Secondary	Collateral lymphatic pathway	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
Secondary	Quality of life lymphedema	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