Reduction of Arm Volume and Improvement in Lymphedema Via Surgery

NCT06606145 | Completed

• 1 other identifier: BUN 143201316894
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to evaluate the effectiveness of lymphatic microsurgical treatments in reducing limb volume in female patients with breast cancer-related lymphedema (BCRL). The study focuses on three treatments: Lymphovenous Anastomosis (LVA), Vascularized Lymph Node Transfer (VLNT), and Complex Decongestive Therapy (CDT). The main questions it aims to answer are:

• Can LVA, VLNT, or their combination significantly reduce limb volume in patients with BCRL?
• How does the effectiveness of these surgical interventions compare to CDT alone? Researchers will compare patients who undergo LVA, VLNT, or a combination of both to those receiving only CDT to determine the effectiveness of surgical interventions in reducing lymphedema symptoms. Participants will:
• Undergo pre- and post-operative limb volume measurements.
• Receive either LVA, VLNT, or combined LVA and VLNT surgery, or continue CDT alone.
• Be monitored for one year to assess changes in limb volume and quality of life.

Conditions

Lymphedema; Lymphedema Arm; Lymphedema of Arm; Lymphedema of Upper Limb; Lymphedema, Secondary

Keywords

lymphedema; lymphovenous anastomosis; vascularized lymph node transplant; LVA; VLNT

Outcome Measures

Primary Outcomes (1)

• Relative interlimb difference

  Change in relative interlimb difference (RID) between the affected and contralateral limb

  Before intervention and one year post-intervention

Secondary Outcomes (1)

• Number of infection episodes after surgery

  One year post-intervention

Study Arms (4)

Lymphovenous Anastomoses (LVA)

EXPERIMENTAL

Patients with BCRL recieve one ore more Lymphovenous Anastomoses (LVA) on the affected limb. This involves connecting functional lymphatic vessels to nearby veins, allowing for the rerouting of lymphatic fluid into the venous system, thus improving lymphatic drainage. All patients had CDT pre- and post-op.

Procedure: Lymphovenous Anastomosis

Vascularized Lymph Node Transfer (VLNT)

EXPERIMENTAL

Patients with BCRL recieve a Vascularized Lymph Node Transfer (VLNT) on the affected limb. This involves transferring healthy lymph nodes along with their blood supply to the affected lymphoedematous area, aiding in lymphatic fluid transport and potentially promoting lymphangiogenesis. All patients had CDT pre- and post-op.

Procedure: Vascularized Lymph Node Transfer

LVA + VLNT

EXPERIMENTAL

Patients with BCRL recieve a combined simultaneous surgical intervention during which both VLNT and one or more LVA are performed on the affected limb. All patients had CDT pre- and post-op.

Procedure: Combined Lymphovenous Anastomosis and Vascularized Lymph Node Transfer

Complex Decongestive Therapy (CDT)

ACTIVE COMPARATOR

Patients with BCRL who refuse to undergo further surgical treatment after breast cancer surgery are offered conservative therapy. The current standard of care for most BRCL patients includes conservative measures known as Complex Decongestive Therapy (CDT) consisting of compression therapy with low-stretch bandages, manual lymphatic drainage, exercise, and skincare.

Procedure: Complex Decongestive Therapy

Interventions

Lymphovenous Anastomosis PROCEDURE

LVA involves connecting functional lymphatic vessels to nearby veins, allowing for the rerouting of lymphatic fluid into the venous system, thus improving lymphatic drainage.

Also known as: LVA, Lymphovenous Bypass, LVB, Lymphaticovenous Anastomosis, Lymphatico-venous Anastomosis

Lymphovenous Anastomoses (LVA)

Vascularized Lymph Node Transfer PROCEDURE

VLNT involves transferring healthy lymph nodes along with their blood supply to the affected lymphoedematous area, aiding in lymphatic fluid transport and potentially promoting lymphangiogenesis.

Also known as: VLNT, Lymph Node Transfer, Lymph Node Transplant, Vascularized Lymph Node Transplant

Vascularized Lymph Node Transfer (VLNT)

Combined Lymphovenous Anastomosis and Vascularized Lymph Node Transfer PROCEDURE

Combined simultaneous surgical intervention during which both VLNT and LVA are performed on the operated limb.

Also known as: LVA + VLNT, LVA & VLNT

LVA + VLNT

Complex Decongestive Therapy PROCEDURE

The current standard of care for most BRCL patients includes conservative measures known as Complex Decongestive Therapy (CDT), consisting of compression therapy with low-stretch bandages, manual lymphatic drainage, exercise, and skincare.

Also known as: CDT

Complex Decongestive Therapy (CDT)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Patients with Breast Cancer-Related Lymphedema (BCRL)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least one of the following persistent complaints of one of the upper extremities: heaviness, pain, recurrent infections

You may not qualify if:

• negative volume difference between affected and normal limb, bilateral mastectomy, bilateral axillary lymph node dissection (ALND), ongoing radio- and chemotherapy, ISL stage III, and receiving other simultaneous debulking procedures during lymphedema surgery.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, Brussel Capital, 1090, Belgium

Location

Related Publications (1)

• Zeltzer AA, Nistor A, Adriaenssens N, Deleuze J, Giunta G, Hamdi M. Outcomes of Lymphovenous Anastomoses and Vascularized Lymph Node Transplant in the Combined Surgical Treatment of Lymphedema: A Prospective Cohort Study. Plast Reconstr Surg. 2026 Jan 1;157(1):163-175. doi: 10.1097/PRS.0000000000012326. Epub 2025 Jul 22.

  PMID: 40707214 DERIVED

MeSH Terms

Conditions

Lymphedema; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Moustapha Hamdi

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 20, 2024
• Study Start: January 1, 2011
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2022
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)