COMBINATION OF LYMPHATICO-VENULAR ANASTOMOSIS AND LIPOSUCTION IN TREATING LYMPHEDEMA

Description of an Effective Surgical Strategy to Treat Cancer Related Lymphedema, a High Incidence Pathology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04536064
• Other study ID #: LVA+LIPOSUCTION IN LYMPHEDEMA
• Status: Enrolling by invitation
• Start date: February 22, 2021
• Est. completion date: May 1, 2025

Study information

• Verified date: February 2021
• Source: University of Siena
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

- 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

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 24
• Est. completion date: May 1, 2025
• Est. primary completion date: September 1, 2022
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

previous lymphadenectomy Exclusion Criteria: free from cancer related pathology

Related Conditions & MeSH terms

• Description of an Effective Surgical Strategy to Treat Cancer Related Lymphedema, a High Incidence Pathology
• Lymphedema

Intervention

Procedure:
• LVA and liposuction
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.

Locations

Country	Name	City	State
Italy	Guido Gabriele	Siena	SI

Sponsors (1)

Lead Sponsor	Collaborator
University of Siena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume reduction of the limb	mesurement of volume reduction	one year after surgery