Lymphedema ArmNCT07233863
Lymphovenous Bypass Procedure for Secondary Prevention of Lymphedema in Breast Cancer
A study testing Lymphovenous bypass (LVB) in people with Lymphedema Arm, run by Dharmais National Cancer Center Hospital at 1 site in Indonesia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema Arm
- What is being tested?
- Lymphovenous bypass (LVB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteIndonesia
- Study dates
- 18 Mar 2024to 21 Mar 2028
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
Dharmais National Cancer Center
Jakarta, Jakarta Special Capital Region, 11420
Natarini Setianingsih, +62 5681570 ext. 2372, dharmais@dharmais.co.id
About this study
Official title: Effectiveness of Lymphovenous Bypass Procedure for Secondary Prevention of Lymphedema in Breast Cancer
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.
Read the 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.
- Conditions
- Lymphedema Arm
- Being tested
- Lymphovenous bypass (LVB)
- Keywords
- Breast Cancer, Lymphedema
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymphovenous bypass (LVB)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Lymphovenous bypass (LVB) | Experimental | 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. Receives: Procedure: Lymphovenous bypass (LVB) |
| Physiotherapy | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCRL improvement rate
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)
Measured: 24 months
Secondary outcomes (2)
Quality of life in lymphedema
Arm symptoms were assessed using the arm symptom scale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-BR23), a 23-item breast cancer-specific supplement to the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The arm symptom scale consists of 3 items: pain in the arm or shoulder, swelling of the arm or hand, and difficulty raising the arm or moving it sideways. Each item is rated on a 4-point scale from 1 (not at all) to 4 (very much). Scale scores are linearly transformed to a range of 0 to 100 according to the EORTC scoring manual; higher scores indicate more severe arm symptoms and worse quality of life.
Measured: 24 months
Adverse event of lymphedema
Complications such as seroma, hematoma, wound separation, bleeding, and wound infection can be seen after surgery.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start18 Mar 2024
- Primary completion21 Mar 2027 (estimated)
- Study completion21 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lymphedema ArmStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a single-blind, pragmatic, parallel arm randomized clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dharmais National Cancer Center Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bayu Brahma, Dharmais National Cancer Center Hospital
- Investigators
- Bayu Brahma, MD, PhD, Principal investigator, Dharmais Cancer Hospital - National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233863
- Sponsor's protocol ID
- DP.04.03/11.5/095/2024
- Status last verified
- Oct 2026
- First submitted
- 14 Nov 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 10993089Brahma 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.
PubMed 33648010Agarwal 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.
PubMed 31631442
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Lymphovenous Bypass Procedure for Secondary Prevention of Lymphedema in Breast Cancer
- ClinicalTrials.gov ID
- NCT07233863
- Acronym / sponsor ID
- DP.04.03/11.5/095/2024
- Conditions
- Lymphedema Arm
- Keywords
- Breast Cancer, Lymphedema
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Dharmais National Cancer Center HospitalOther government
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 21 Mar 2027 (estimated)
- Study completion
- 21 Mar 2028 (estimated)
- First posted
- 18 Nov 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is a single-blind, pragmatic, parallel arm randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Lymphovenous bypass (LVB) | Experimental | Procedure: 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. |
| Physiotherapy | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| 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. | Procedure or surgery | Lymphovenous bypass (LVB) |
Primary outcome
BCRL improvement rate
Time frame: 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)
2 secondary outcomes
Quality of life in lymphedema
Time frame: 24 months
Adverse event of lymphedema
Time frame: 24 months
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 27 Oct 2026.
- Results publication: PubMed 10993089Koshima 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.
- Results publication: PubMed 33648010Brahma 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.
- Results publication: PubMed 31631442Agarwal 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.
- Individual participant dataSharing planned: Undecided
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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.
Bayu Brahma, MD, PhD principal investigator
Dharmais Cancer Hospital - National Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymphovenous bypass (LVB) in people with Lymphedema Arm, run by Dharmais National Cancer Center Hospital at 1 site in Indonesia.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Adhitya B Perdana, MEpi (+62 85692445029, adhityabayu@dharmais.co.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCRL improvement rate (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07233863, which also lists 3 linked publications.
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 27 Oct 2026.