CClinicalTrials.gg
Enrolling by invitationNCT04536064Updated Feb 24, 2021

COMBINATION OF LYMPHATICO-VENULAR ANASTOMOSIS AND LIPOSUCTION IN TREATING LYMPHEDEMA

An observational study in Description of an Effective Surgical Strategy to Treat Cancer Related Lymphedema, a High Incidence Pathology, sponsored by University of Siena. Enrolling by invitation at 1 site in Italy. Per ClinicalTrials.gov, last updated 2021-02-24.

Sponsored by University of Siena · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2022, 4 years 1 month ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
24
Sex
All
01

Study 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
Read the detailed 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.

02

Conditions studied

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

Browse trials for

Keywords

  • lymphedema
  • lva
  • liposuction
  • treatment
03

In context

Lymphedema

560 studies on the registry are indexed under Lymphedema; 135 are open to participants now.

This study's enrollment of 24 is below the median of 106 across 144 observational studies indexed under Lymphedema.

Browse Lymphedema studies →

Lead sponsor

University of Siena is the lead sponsor of 65 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

Study population

24 patients with secondary lymphedema

Inclusion criteria

previous lymphadenectomy

Exclusion criteria

Exclusion Criteria:

free from cancer related pathology

05

Study design

Observational model
Other
Time perspective
Other
Enrollment
24 participants (actual)
Patient registry
No

Interventions

  • ProcedureLVA 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.

06

What researchers measure

Primary outcomes

  1. Volume reduction of the limb

    mesurement of volume reduction

    Time frame: one year after surgery

07

Study locations

1 site
  • Guido Gabriele
    Siena, SI 54100, Italy
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04536064
Lead sponsor
University of Siena
Responsible party
Guido Gabriele (MD, University of Siena) — Principal investigator
First posted
Sep 2, 2020
Start date
Feb 22, 2021
Primary completion
Sep 1, 2022 (estimated)
Completion
May 1, 2025 (estimated)
Last update
Feb 24, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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