Breast Cancer-Related LymphedemaSLVA-PULLNCT07026292
Supermicrosurgical Lymphaticovenous Anastomosis for Prevention of Upper Limb Lymphedema
A study testing Immediate Distal Lymphaticovenous Anastomosis (ID-LVA) in people with Breast Cancer-Related Lymphedema and Lymphedema, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer-Related Lymphedema, Lymphedema, Breast Cancer Invasive
- What is being tested?
- Immediate Distal Lymphaticovenous Anastomosis (ID-LVA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 31 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >=18 years;
- Female;
- Pathologically confirmed invasive breast cancer;
- Unilateral breast cancer;
- Clinical stage T1-4 and N1-3 (post-neoadjuvant therapy staging for patients receiving neoadjuvant treatment);
- No clinical or radiographic evidence of distant metastasis;
- Scheduled to undergo axillary lymph node dissection with planned adjuvant radiotherapy;
- Willing and able to provide written informed consent.
Who cannot join
- Currently participating in other clinical trials that, in the investigator's judgment, may affect upper limb lymphatic drainage.
- No definitive indication for axillary lymph node dissection or adjuvant radiotherapy after neoadjuvant therapy.
- Pregnant or lactating women.
- Patients undergoing concurrent autologous tissue flap breast reconstruction or chest wall repair.
- Upper limb deformities, prior upper limb trauma, or surgical history that, in the investigator's assessment, may compromise lymphatic drainage.
- Pre-existing upper limb lymphedema at baseline.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase Ⅲ, Multicenter, Prospective, Open-Label, Controlled Study of Supermicrosurgical Lymphaticovenous Anastomosis for Prevention of Upper Limb Lymphedema in Breast Cancer Patients Following Axillary Lymph Node Dissection and Adjuvant Radiotherapy
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.
- Being tested
- Immediate Distal Lymphaticovenous Anastomosis (ID-LVA)
- Keywords
- Supermicrosurgical Lymphaticovenous Anastomosis, Lymphedema, Breast Cancer, Prevention, Immediate Distal Lymphaticovenous Anastomosis
- Medical subject headings
- Breast Cancer Lymphedema, Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Distal Lymphaticovenous Anastomosis (ID-LVA)Procedure or surgery
Also called Supermicrosurgical Lymphaticovenous Anastomosis
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.
| Study group | Role | What they receive |
|---|---|---|
| ID-LVA Group | Experimental | Immediate distal lymphaticovenous anastomosis (ID-LVA) performed concomitantly with axillary lymph node dissection (ALND) Receives: Procedure: Immediate Distal Lymphaticovenous Anastomosis (ID-LVA) |
| non-ID-LVA Group | No intervention | Axillary lymph node dissection (ALND) without concurrent immediate distal lymphaticovenous anastomosis (ID-LVA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 24 months after surgery
Secondary outcomes (8)
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.
Measured: From enrollment to 24 months after surgery
Lymphedema-Associated Symptoms
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.
Measured: 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.
Measured: From enrollment to 24 months after surgery
Surgery-Related Complications
Measured: From the day of surgery to 1 month after surgery
Radiation-Related Complications
Measured: From the day of radiation to 7 days after radiation
Disease-Free Survival (DFS)
Measured: From enrollment to 24 months after surgery
Local Recurrence-Free Survival (LRFS)
Measured: From enrollment to 24 months after surgery
Overall Survival (OS)
Measured: From enrollment to 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer-Related LymphedemaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026292
- Sponsor's protocol ID
- E20250412
- Other IDs
- TZ3582023-013
- Acronym
- SLVA-PULL
- Status last verified
- May 2025
- First submitted
- 24 May 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the trial, only IPD used in the results publication.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅲ, Multicenter, Prospective, Open-Label, Controlled Study of Supermicrosurgical Lymphaticovenous Anastomosis for Prevention of Upper Limb Lymphedema in Breast Cancer Patients Following Axillary Lymph Node Dissection and Adjuvant Radiotherapy
- ClinicalTrials.gov ID
- NCT07026292
- Acronym / sponsor ID
- SLVA-PULL / E20250412
- Keywords
- Supermicrosurgical Lymphaticovenous Anastomosis, Lymphedema, Breast Cancer, Prevention, Immediate Distal Lymphaticovenous Anastomosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ID-LVA Group | Experimental | Procedure: Immediate Distal Lymphaticovenous Anastomosis (ID-LVA)Immediate distal lymphaticovenous anastomosis (ID-LVA) performed concomitantly with axillary lymph node dissection (ALND) |
| non-ID-LVA Group | No intervention | –Axillary lymph node dissection (ALND) without concurrent immediate distal lymphaticovenous anastomosis (ID-LVA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age >=18 years;
- Female;
- Pathologically confirmed invasive breast cancer;
- Unilateral breast cancer;
- Clinical stage T1-4 and N1-3 (post-neoadjuvant therapy staging for patients receiving neoadjuvant treatment);
Key exclusion criteria (6 listed)
- Currently participating in other clinical trials that, in the investigator's judgment, may affect upper limb lymphatic drainage.
- No definitive indication for axillary lymph node dissection or adjuvant radiotherapy after neoadjuvant therapy.
- Pregnant or lactating women.
- Patients undergoing concurrent autologous tissue flap breast reconstruction or chest wall repair.
- Upper limb deformities, prior upper limb trauma, or surgical history that, in the investigator's assessment, may compromise lymphatic drainage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate Distal Lymphaticovenous Anastomosis (ID-LVA)Also: Supermicrosurgical Lymphaticovenous AnastomosisID-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. | Procedure or surgery | ID-LVA Group |
Primary outcome
Lymphedema incidence
Time frame: From enrollment to 24 months after surgery
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.
8 secondary outcomes
Lymphedema Severity
Time frame: From enrollment to 24 months after surgery
Lymphedema-Associated Symptoms
Time frame: From enrollment to 24 months after surgery
Quality of Life (QoL)
Time frame: From enrollment to 24 months after surgery
Surgery-Related Complications
Time frame: From the day of surgery to 1 month after surgery
Radiation-Related Complications
Time frame: From the day of radiation to 7 days after radiation
Disease-Free Survival (DFS)
Time frame: From enrollment to 24 months after surgery
Local Recurrence-Free Survival (LRFS)
Time frame: From enrollment to 24 months after surgery
Overall Survival (OS)
Time frame: From enrollment to 24 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: Yes. All IPD collected throughout the trial, only IPD used in the results publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Distal Lymphaticovenous Anastomosis (ID-LVA) in people with Breast Cancer-Related Lymphedema and Lymphedema, run by Tianjin Medical University Cancer Institute and Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongmeng Zhao (+86 22 6515 0123 ext. 8500/8520, zhaohongmeng@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymphedema incidence (time frame: From enrollment to 24 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.