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NCT Number: NCT07233863

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dharmais National Cancer Center

Jakarta, Jakarta Special Capital Region, 11420, Indonesia

Location status: Recruiting

Location contact

Natarini Setianingsih

CONTACT

[email protected]

+62 5681570 ext. 2372

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Quality of life in lymphedema

    Time frame: 24 months

    QLQ-BR23 is a supplement to the EORTC QLQ-30, specific to breast cancer patients, containing 23 questions and scored from 0 (not at all) to 4 (very much). To evaluate the quality of life, we asked three questions about the arm (pain, swelling, and mobility issues). The quality of life decreases with a higher score.

  2. Adverse event of lymphedema

    Time frame: 24 months

    Complications such as seroma, hematoma, wound separation, bleeding, and wound infection can be seen after surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Adhitya B Perdana, MEpi

CONTACT

[email protected]

+62 85692445029

Sponsors and collaborators

Lead sponsor

Dharmais National Cancer Center Hospital

Other Gov

Registry information

Official study title

Effectiveness of Lymphovenous Bypass Procedure for Secondary Prevention of Lymphedema in Breast Cancer

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Nov 18, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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