Clinical trial NCT05682885: The Effectiveness of Lymphatic Bypass Supermicrosurgery
Official title: The Effectiveness of Lymphatic Bypass Supermicrosurgery for Primary Lymphedema Prevention After Breast Cancer Axillary Lymph Node Dissection: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer Related Lymphedema
Lymphedema Arm
Keywords: Lymphatic Bypass Supermicrosurgery
Primary Lymphedema Prevention
Axillary Lymph Node Dissection
Lead sponsor: Dharmais National Cancer Center Hospital
Sponsor class: OTHER_GOV
First posted: 2023-01-12
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a single-blind pragmatic parallel arm randomized clinical trial to analyze the effectiveness of lymphatic bypass supermicrosurgery (LBS).
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative incidence of BCRL
timeFrame: 1 year
Secondary outcomes:
measure: BCRL and SCL progression-free survival rate
timeFrame: 1 year
measure: Collateral lymphatic pathway
timeFrame: 1 year
measure: Quality of life lymphedema
timeFrame: 1 year
Other outcomes:
measure: Association of body mass index (BMI) with BCRL
timeFrame: 1 year
measure: Association of number of axillary lymph nodes metastases with BCRL
timeFrame: 1 year
measure: Association of number of taxane chemotherapy with BCRL
timeFrame: 1 year
measure: Association of regional lymph node radiation with BCRL
timeFrame: 1 year
measure: Association of axillary fat weight with BCRL
timeFrame: 1 year
Locations:
city: Jakarta
country: Indonesia
facility: Dharmais National Cancer Center Hospital
Study officials:
affiliation: Dharmais Hospital National Cancer Center, Indonesia
name: Bayu Brahma, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
citation: 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.
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.
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.
citation: Suami H. Anatomical Theories of the Pathophysiology of Cancer-Related Lymphoedema. Cancers (Basel). 2020 May 23;12(5):1338. doi: 10.3390/cancers12051338.