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Lidocaine

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Tumescent technique in lymph-sparing fashion was adopted. Areas were infiltrated with a mix of a standard tumescent solution consisting for each liter of in 1000 ml of saline solution, 50 ml lidocaine 1%, 1 ml epinephrine 1:1000, 10 ml bicarbonate 8,4%. Infiltration volume was approximately from 0,5 to 1 liter for the upper extremities and 1-2 liters for lowers. Three to 4 mm 3 holes blunt cannulas were employed. Aspiration technique was as parallel as possible along the lymphatic network pattern and from superficial to deep layers.

Lymphatic vessels identified at ICG lymphography were spared. Volume of the aspirate was aimed to approximate 80 percent of the volume difference between the affected and non affected side.

The number and type of anastomosis were recorded as well as amount of removed lipoaspirate versus the excess limb volume.

LVA and liposuction

* cooperation of an International team with many years of experience in surgical management of lymphedema
* description of an effective surgical strategy to treat cancer-related lymphedema, a high incidence pathology
* the combination of LVA and liposuction guarantees long lasting results

Cancer-related lymphedema represents one of the major complications of cancer treatment, especially for breast and gynecologic cancers. Moreover, it has high impact on cancer survivors and healthcare systems. Lymphedema management still remains challenging. The better understanding of lymphedema physiopathology as well as the development of sophisticated surgical and diagnostic techniques have led to effective strategies to address lymphedema patients but, despite the considerable interest in international literature, no consensus exist.

The authors present a retrospective analysis of 24 consecutive patients affected by cancer-related lymphedema treated by the combination of LVA and liposuction in the same surgical session. Patients data regarding limb volume, lymphangitis rate and quality of life index were assessed before surgery and 1 year after surgery.

One year after surgery an average volume reduction of 37,9% was registered. Lymphangitis rate significantly decreased after surgery to 0.95 per year. Quality of life score improved.

CONCLUSIONS The combination of LVA and liposuction represents an effective strategy in treating patients with cancer-related lymphedema, ensuring a significant decrease in volume and reduction of lymphangitis rate as well as stable results in time. In addition, it appears to be minimally invasive and well tolerated by patients, since it can be performed under local anesthesia with low risk of complications.

COMBINATION OF LYMPHATICO-VENULAR ANASTOMOSIS AND LIPOSUCTION IN TREATING LYMPHEDEMA

COMBINATION OF LYMPHATICO-VENULAR ANASTOMOSIS AND LIPOSUCTION TO TREAT CANCER-RELATED LYMPHEDEMA: RATIONALE FOR A REGIONAL APPROACH

University of Siena

Neoplasms

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Breast Neoplasms

Breast Cancer Lymphedema

Postoperative Complications

Liposuction is performed on the abdomen or thighs.

Liposuction

30mL harvested lipoaspirate is injected at the affected axillary site.

Fat graft

30mL saline is injected at the affected axillary site.

Sham graf (Saline injection)

4mL stem cell suspension injected at the affected axillary site.

Stem cell injection

4mL saline injected at the affected axillary site.

Saline injection

Jens A Sørensen, MD, PhD

Breast cancer-related lymphedema is one of the most common and feared consequences of breast cancer treatment. Currently, lymphedema is primarily addressed conservatively with compression garments. Regenerative medicine may provide a new treatment option for lymphedema. This Phase 3 trial will examine the efficacy, effectiveness and safety of freshly isolated adipose-derived stromal cells administered in conjunction with a fat grafting procedure to the affected axillary region.

All patients undergo the same liposuction procedure. During general anesthesia, patients are randomized to either fat grafting or sham grafting with saline injection to the axilla. After stem cell suspension, patients receive either stem cell or saline injection depending on randomization using masked syringes.

Participants are blinded, care providers postoperatively are blinded, primary investigator is blinded and all outcome assessors are blinded. The surgeon performing the liposuction and the stem-cell staff are unblinded.

Treatment of Breast Cancer-related Lymphedema With Stem Cells and Fat Grafting

Assessed using clinical circumference measurement

Any side effects to treatments. Assessed by asking the patient at each visit.

Subjective change of lymphedema assessed by questionnaire. Range: 0-100. 100 being the most bothered.

Subjective change of lymphedema assessed by questionnaire. Range: 1-5. 5 being the most bothered

Subjective change of quality of life assessed by questionnaire. Range: 0-100. 0 being the most bothered.

Change in lymph drainage assessed by indocyanine-green lymphangiography

Change in use or type of conservative lymphedema treatments

Change in infection rates and sick-days due to lymphedema.

Change in L-DEX score of lymphedema arm derived from bioimpedance. Higher values mean more fluid in the lymphedema arm compared to the healthy arm.

Assessed using dual energy x-ray absorptiometry (DXA) scan. Change in values from baseline.

Odense University Hospital

Principal Investigator

Breast Diseases

Skin Diseases

Anesthetics

Liposuction, followed by Quality of Life Questionnaires and extended follow-up period.

Liposuction is a procedure that involves the removal of fat from deposits beneath the skin using a hollow stainless steel tube with the assistance of a powerful vacuum. Liposuction can be accomplished either with the use of local or general anesthesia.

Ratings of 0 to 4, with 0 being Not at ll and 4 being Very Much, regarding how true each statement has been. Statements are in the following categories: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, Additional Concerns.

Quality of Life Questionnaires

Christine Laronga, M.D.

The purpose of this study is to determine if a less invasive procedure such as liposuction can be used to effectively reduce arm lymphedema (swelling of the arm) resulting from breast cancer treatment. The standard surgery involves the removal of large portions of skin and tissue leaving a large scar. This less invasive procedure (liposuction) uses 3 to 4 tiny puncture sites and a vacuum tube leaving minimal scars.

Liposuction for Arm Lymphedema Following Breast Cancer Surgery

Investigators plan to show the efficacy of liposuction as a treatment for lymphedema. Investigators will contrast the arm volume at 3 months with the baseline value using a paired t-test. Because the change in volume is likely to be proportional to the baseline value, the logarithm of the volumes will be used. With α = .05 and n = 34, we will have 80% power to detect an effect size of 0.5 (that is, a change of 0.5 standard deviations between the baseline and 3-month mean volumes). However since this is a pilot study with limited funding the study will initially open for 7 patients to assess safety and feasibility.

Durability will be tested for equivalence, by comparing the 3-month and 12-month arm volumes. Five year follow-up is necessary to demonstrate the lasting effect of liposuction in reducing arm lymphedema.

Measures to reduce skin infections will be implemented in this study but observance of infections will be an important study endpoint.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
COMBINATION OF LYMPHATICO-VENULAR ANASTOMOSIS AND LIPOSUCTION IN TREATING LYMPHEDEMA	NCT04536064	Description of ...	LVA and liposuc...	-	University of Siena
Treatment of Breast Cancer-related Lymphedema With Stem Cells and Fat Grafting	NCT03776721	Lymphedema	Liposuction Fat graft Sham graf (Sali... Stem cell injec... Saline injectio...	18 Years -	Odense University Hospital
Liposuction for Arm Lymphedema Following Breast Cancer Surgery	NCT00816985	Breast Cancer	Liposuction Quality of Life...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for liposuction

Every month we try and update this database with for liposuction cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for liposuction

Every month we try and update this database with for liposuction cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for liposuction cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.