Lymphovenous Bypass Procedure for Secondary Prevention of Lymphedema in Breast Cancer

November 14, 2025 updated by: Bayu Brahma, Dharmais National Cancer Center Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Indonesia
    • Jakarta Special Capital Region
      • Jakarta, Jakarta Special Capital Region, Indonesia, 11420
        • Recruiting
        • Dharmais National Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: 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.
No Intervention: Physiotherapy
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months
Adverse event of lymphedema
Time Frame: 24 months
Complications such as seroma, hematoma, wound separation, bleeding, and wound infection can be seen after surgery.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dharmais National Cancer Center Hospital

Investigators

  • Principal Investigator: Bayu Brahma, MD, PhD, Dharmais Cancer Hospital - National Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2024

Primary Completion (Estimated)

March 21, 2027

Study Completion (Estimated)

March 21, 2028

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 18, 2025

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DP.04.03/11.5/095/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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