Lymphovenous Bypass Procedure for Secondary Prevention of Lymphedema in Breast Cancer

NCT07233863 | Recruiting DMC

• 1 other identifier: DP.04.03/11.5/095/2024
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphedema Arm

Keywords

Breast Cancer; Lymphedema

Outcome Measures

Primary Outcomes (1)

• 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)

  24 months

Secondary Outcomes (2)

• Quality of life in lymphedema

  24 months

• Adverse event of lymphedema

  24 months

Study Arms (2)

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.

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.

Interventions

Lymphovenous bypass (LVB) PROCEDURE

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.

Lymphovenous bypass (LVB)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dharmais National Cancer Center Hospital: lead

Study Sites (1)

Dharmais National Cancer Center

Jakarta, Jakarta Special Capital Region, 11420, Indonesia

RECRUITING

Related Publications (3)

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Bayu Brahma, MD, PhD

  Dharmais Cancer Hospital - National Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adhitya B Perdana, MEpi

CONTACT

+62 85692445029; adhityabayu@dharmais.co.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: This study is a single-blind, pragmatic, parallel arm randomized clinical trial

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: March 18, 2024
• Primary Completion (Estimated): March 21, 2027
• Study Completion (Estimated): March 21, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

ID (1)