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| ID | Type | Description | Link |
|---|---|---|---|
| TZ3582023-013 | Other Grant/Funding Number | Tianjin Medical University Cancer Institute and Hospital |
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Breast cancer-related lymphedema (BCRL) is one of the most common chronic complications following breast cancer treatment. This study enrolls breast cancer patients who are required to undergo axillary lymph node dissection and postoperative adjuvant radiotherapy. Based on patients' preferences, they will be assigned to receive either immediate distal lymphaticovenous anastomosis (ID-LVA) following axillary lymph node dissection (experimental group) or not (control group). The study aims to evaluate the safety and efficacy of ID-LVA in preventing breast cancer-related upper limb lymphedema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ID-LVA Group | Experimental | Immediate distal lymphaticovenous anastomosis (ID-LVA) performed concomitantly with axillary lymph node dissection (ALND) |
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| non-ID-LVA Group | No Intervention | Axillary lymph node dissection (ALND) without concurrent immediate distal lymphaticovenous anastomosis (ID-LVA) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate Distal Lymphaticovenous Anastomosis (ID-LVA) | Procedure | ID-LVA (Immediate Distal Lymphaticovenous Anastomosis) is an supermicrosurgical technique performed during axillary lymph node dissection (ALND) to prevent breast cancer-related lymphedema, offering the dual advantages of immediate intervention and radiation-field avoidance. Compared to LYMPHA (Lymphatic Microsurgical Preventive Healing Approach), which utilizes proximal axillary anastomoses within the radiation field with larger vessels and higher venous pressure, ID-LVA creates precise anastomoses between 0.3-0.8mm distal superficial lymphatic vessels and low-pressure venules in the upper arm. In contrast to DD-LVA (Delayed Distal Lymphaticovenous Anastomosis) performed postoperatively (typically 4-12 weeks after ALND) for subclinical lymphedema, ID-LVA provides earlier prevention by utilizing undamaged lymphatics and avoids the need for a second procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Lymphedema incidence | Breast cancer-related lymphedema (BCRL) was assessed using relative volume change (RVC) derived from circumferential measurements of both upper limbs. Certified lymphedema therapists performed standardized measurements at anatomical landmarks: the web space, ulnar styloid midpoint, and points 10, 20, 30, and 40 cm above the ulnar styloid; axillary measurements were added if needed. Segmental volumes were calculated using the truncated cone formula: V = (πh/12) × (C₁² + C₁C₂ + C₂²), where h = 10 cm, and C₁, C₂ are circumferences at segment ends. Total arm volume was the sum of all segments. RVC was computed as: RVC = (A₂U₁) / (A₁U₂) × 100%, where A₁/A₂ = pre-/postoperative volume of the affected arm, and U₁/U₂ = pre-/postoperative volume of the unaffected arm. If weight fluctuated significantly, weight-adjusted change (WAC) was calculated: WAC = (A₂ × W₁) / (W₂ × A₁) - 1, where W₁ and W₂ represent the preoperative and postoperative body weight. | From enrollment to 24 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Lymphedema Severity | The severity of lymphedema is classified into stages 0 to Ⅲ by breast surgeons and lymphedema therapists according to the International Society of Lymphology (ISL) staging system. | From enrollment to 24 months after surgery |
| Lymphedema-Associated Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongmeng Zhao | Contact | +86 22 6515 0123 | 8500/8520 | zhaohongmeng@tjmuch.com |
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All IPD collected throughout the trial, only IPD used in the results publication.
From June 1, 2025 to May 31, 2029.
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Upper limb lymphedema symptoms were assessed using a patient self-reported format. The Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI), developed by Fu et al., was employed to evaluate patients' experiences of lymphedema-related symptoms. The scale consists of two components: symptom occurrence and symptom distress. In this study, only the symptom occurrence component was used, which includes 24 items. Each item is rated on a 5-point Likert scale (0 = not at all to 4 = very much), yielding a total score ranging from 0 to 96. Higher scores indicate more severe symptoms. Additionally, each item can be treated as a categorical variable based on the presence or absence of the symptom. The Cronbach's alpha coefficient for this scale is 0.930. |
| From enrollment to 24 months after surgery |
| Quality of Life (QoL) | Quality of life was evaluated using the Functional Assessment of Cancer Therapy - Breast (FACT-B), a validated patient-reported outcome measure developed by David Cella and colleagues as part of the Functional Assessment of Chronic Illness Therapy (FACIT) system, under the Center on Outcomes, Research and Education (CORE) at Northwestern University, United States. The FACT-B consists of 36 items across five domains: physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns. Each item is rated on a 4-point Likert scale (0 = not at all to 4 = very much), with higher scores indicating better quality of life. The Chinese version was translated and culturally adapted by Wan Chonghua et al., with reported Cronbach's alpha coefficients ranging from 0.61 to 0.84. | From enrollment to 24 months after surgery |
| Surgery-Related Complications | From the day of surgery to 1 month after surgery |
| Radiation-Related Complications | From the day of radiation to 7 days after radiation |
| Disease-Free Survival (DFS) | From enrollment to 24 months after surgery |
| Local Recurrence-Free Survival (LRFS) | From enrollment to 24 months after surgery |
| Overall Survival (OS) | From enrollment to 24 months after surgery |
| ID | Term |
|---|---|
| D000072656 | Breast Cancer Lymphedema |
| D008209 | Lymphedema |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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