Effectiveness of Lymphovenous Bypass Procedure for Secondary Prevention of Lymphedema in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- BCRL improvement rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Blinding is implemented in two conditions: the principal researcher (Bayu Brahma) will not know the patient's identity or medical history when assessing indocyanine green (ICG) lymphography results, and the patients will not see the type of treatment they received.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Lymphovenous bypass (LVB)
Sixty-eight subjects will be needed per group. LVB was performed by creating an intima-to-intima anastomosis between the afferent lymphatic vessels and the recipient veins. After surgery, follow-up will be done every 6 months for 2 years. During follow-up, a comprehensive evaluation will be performed, including history and physical examinations, radiological and histopathological examinations, UEL index, ICG lymphography, and quality-of-life evaluation. Each subject will complete the Lymphedema Quality of Life Questionnaire.
干预措施: Lymphovenous bypass (LVB) (Procedure)
Physiotherapy
Sixty-eight subjects will be needed per group. Patients will receive physiotherapy from trained physiotherapists. The protocol includes manual lymphatic drainage (massage techniques), compression, skin care, and arm exercises. Follow-up will be done every 6 months for 2 years. During follow-up, a comprehensive evaluation will be performed, including history and physical examinations, radiological and histopathological examinations, UEL index, ICG lymphography, and quality-of-life evaluation. Each subject will complete the Lymphedema Quality of Life Questionnaire.
结局指标
主要结局
BCRL improvement rate
时间窗: 24 months
BCRL definition: Post-operation subject condition with the presence of minimum DB 2 with one or both symptoms (swelling, heaviness), and an 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 pathways (anterior or posterior), without presence of symptoms (swelling or heaviness), and increment of UEL index \>10% compared to pre-operation. International Society of Lymphology (ISL) stage 1 definition: An early stage of lymphedema is characterized by soft tissue swelling that may subside with limb elevation or overnight rest, without permanent structural changes. BCRL improvement : Improvement in ICG lymphography stage with or without clinical signs (UEL \<10% and or symptoms improvement)
次要结局
- Quality of life in lymphedema(24 months)
- Adverse event of lymphedema(24 months)
研究者
Bayu Brahma
MD, PhD
Dharmais National Cancer Center Hospital