Lymphovenous Bypass Procedure for Secondary Prevention of Lymphedema in Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lymphovenous bypass (LVB).
- Who it may be relevant to
- Registry conditions: Lymphedema Arm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Indonesia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of Lymphovenous Bypass Procedure for Secondary Prevention of Lymphedema in Breast Cancer
Overview
This study aims to evaluate the effectiveness of the Lymphovenous Bypass (LVB) procedure compared to physiotherapy alone as secondary prevention of lymphedema in breast cancer patients undergoing axillary lymph node dissection.
Detailed description
In the intervention group, LVB was performed with intima-to-intima coaptation using the super microsurgery technique. The anastomosis was between the afferent lymphatic vessel and the recipient vein. The upper extremity lymphedema (UEL) index and indocyanine green (ICG) lymphography are utilized to evaluate the progression of lymphedema.
Interventions
- Procedure Lymphovenous bypass (LVB)
The Lymphovenous Bypass (LVB) procedure in this study is a microsurgical supermicrosurgery-based intervention specifically designed for the secondary prevention of breast cancer-related lymphedema following axillary lymph node dissection.
Primary outcome measures
- BCRL improvement rate [Time frame: 24 months]
Secondary outcome measures (2)
- Quality of life in lymphedema [Time frame: 24 months]
- Adverse event of lymphedema [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- Breast cancer patients aged ≥ 18 years with an ECOG score > 1
- Breast cancer patients with post-axillary lymph node dissection diagnosed with stage 0 and I lymphedema.
- Those who have never undergone lymphedema physiotherapy.
Exclusion criteria
- Patients with dermal backflow before axillary lymph node dissection (ALND).
- Patients with breast cancer lymphedema who are unable to undergo a 24-month follow-up at Dharmais Cancer Hospital.
- Patients with iodine allergy, severe asthma, decreased kidney function, pregnancy, or breastfeeding.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Indonesia · 1 center
- Dharmais National Cancer Center — Jakarta
Publications
- Koshima I, Inagawa K, Urushibara K, Moriguchi T. Supermicrosurgical lymphaticovenular anastomosis for the treatment of lymphedema in the upper extremities. J Reconstr Microsurg. 2000 Aug;16(6):437-42. doi: 10.1055/s-2006-947150. PMID 10993089
- 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. PMID 33648010
- Agarwal S, Garza RM, Chang DW. Lymphatic Microsurgical Preventive Healing Approach (LYMPHA) for the prevention of secondary lymphedema. Breast J. 2020 Apr;26(4):721-724. doi: 10.1111/tbj.13667. Epub 2019 Oct 20. PMID 31631442
Identifiers
NCT: NCT07233863 · DP.04.03/11.5/095/2024