Reduction of Arm Volume and Improvement in Lymphedema Via Surgery

NCT ID: NCT06606145

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 179 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2022-12-31

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.

Detailed Description

This clinical trial aims to explore the effectiveness of surgical interventions for breast cancer-related lymphedema (BCRL), a chronic and often debilitating condition caused by lymphatic system damage following breast cancer treatments, such as lymph node dissection or radiation therapy. BCRL affects a significant proportion of breast cancer survivors, leading to arm swelling, discomfort, restricted mobility, and recurrent infections.

Standard management of BCRL includes conservative measures known as Complex Decongestive Therapy (CDT), which involves manual lymphatic drainage, compression therapy, exercise, and skincare. While CDT offers symptomatic relief, it does not address the underlying lymphatic dysfunction. In contrast, microsurgical procedures like Lymphovenous Anastomosis (LVA) and Vascularized Lymph Node Transfer (VLNT) are emerging as more definitive treatments for BCRL, targeting the lymphatic system itself.

LVA involves connecting small functional lymphatic vessels to nearby veins, allowing lymphatic fluid to bypass damaged lymph nodes and enter the venous system, improving drainage. It is particularly suited for patients with early-stage lymphedema (ISL stage I) where functional lymphatic vessels are still present.

VLNT involves transferring healthy lymph nodes along with their blood supply from a donor site (such as the groin or lateral thorax) to the affected area, promoting lymphangiogenesis and improving lymphatic transport. VLNT is more suitable for advanced stages of lymphedema (ISL stage II), where lymphatic vessels are more severely damaged.

The study will evaluate the outcomes of patients who undergo LVA, VLNT, or a combination of both, in comparison to a control group receiving only CDT. The surgical selection is based on preoperative imaging with indocyanine green (ICG) lymphography to assess the status of the lymphatic system. Each patient's lymphedema stage, severity, and individual characteristics are taken into consideration when choosing the most appropriate treatment.

Patients will be followed for one year postoperatively to measure the effectiveness of each treatment, with the primary outcome being limb volume reduction. Limb volume will be assessed using a perometer, an objective and reliable tool for measuring arm volume. Secondary outcomes include improvement in quality of life, frequency of infections, and the need for ongoing CDT post-surgery.

This study seeks to provide valuable insights into the comparative effectiveness of LVA, VLNT, and CDT in managing BCRL. While the benefits of microsurgical interventions are promising, particularly in reducing limb volume and infections, this trial aims to provide robust evidence to guide clinical decision-making and improve patient outcomes. By comparing different approaches, the study will help to clarify which surgical interventions are most beneficial for different stages of BCRL and establish clearer selection criteria for these treatments.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lymphovenous Anastomoses (LVA)

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.

Group Type: EXPERIMENTAL

Lymphovenous Anastomosis

Intervention Type: 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.

Vascularized Lymph Node Transfer (VLNT)

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.

Group Type: EXPERIMENTAL

Vascularized Lymph Node Transfer

Intervention Type: 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.

LVA + VLNT

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.

Group Type: EXPERIMENTAL

Combined Lymphovenous Anastomosis and Vascularized Lymph Node Transfer

Intervention Type: PROCEDURE

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

Complex Decongestive Therapy (CDT)

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.

Group Type: ACTIVE_COMPARATOR

Complex Decongestive Therapy

Intervention Type: 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.

Interventions

Lymphovenous Anastomosis

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

Intervention Type: PROCEDURE

Vascularized Lymph Node Transfer

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.

Intervention Type: PROCEDURE

Combined Lymphovenous Anastomosis and Vascularized Lymph Node Transfer

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

Intervention Type: PROCEDURE

Complex Decongestive 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.

Intervention Type: PROCEDURE

Other Intervention Names

LVA; Lymphovenous Bypass; LVB; Lymphaticovenous Anastomosis; Lymphatico-venous Anastomosis; VLNT; Lymph Node Transfer; Lymph Node Transplant; Vascularized Lymph Node Transplant; LVA + VLNT; LVA & VLNT; CDT

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Moustapha Hamdi

Prof. Dr. Moustapha Hamdi

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universitair Ziekenhuis Brussel

Jette, Brussel Capital, Belgium

Countries

Belgium

Other Identifiers

BUN 143201316894

Identifier Type: -

Identifier Source: org_study_id