Description of an Effective Surgical Strategy to Treat Cancer Related Lymphedema, a High Incidence PathologyNCT04536064
COMBINATION OF LYMPHATICO-VENULAR ANASTOMOSIS AND LIPOSUCTION IN TREATING LYMPHEDEMA
An observational study of Description of an Effective Surgical Strategy to Treat Cancer Related Lymphedema, a High Incidence Pathology, run by University of Siena at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Description of an Effective Surgical Strategy to Treat Cancer Related Lymphedema, a High Incidence Pathology
- What is being tested?
- LVA and liposuction
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 22 Feb 2021to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: 24 patients with secondary lymphedema
Who may be able to join
- previous lymphadenectomy
Who cannot join
- free from cancer related pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COMBINATION OF LYMPHATICO-VENULAR ANASTOMOSIS AND LIPOSUCTION TO TREAT CANCER-RELATED LYMPHEDEMA: RATIONALE FOR A REGIONAL APPROACH
- 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.
- Being tested
- LVA and liposuction
- Keywords
- lymphedema, lva, liposuction, treatment
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LVA and liposuctionProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume reduction of the limb
mesurement of volume reduction
Measured: one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start22 Feb 2021
- Primary completion1 Sep 2022 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Description of an Effective Surgical Strategy to Treat Cancer Related Lymphedema, a High Incidence PathologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guido Gabriele, University of Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536064
- Sponsor's protocol ID
- LVA+LIPOSUCTION IN LYMPHEDEMA
- Status last verified
- Feb 2021
- First submitted
- 27 Aug 2020
- Last updated
- 24 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMBINATION OF LYMPHATICO-VENULAR ANASTOMOSIS AND LIPOSUCTION TO TREAT CANCER-RELATED LYMPHEDEMA: RATIONALE FOR A REGIONAL APPROACH
- ClinicalTrials.gov ID
- NCT04536064
- Acronym / sponsor ID
- LVA+LIPOSUCTION IN LYMPHEDEMA
- Keywords
- lymphedema, lva, liposuction, treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 2 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 24 patients with secondary lymphedema
Key inclusion criteria (1 listed)
- previous lymphadenectomy
Key exclusion criteria (1 listed)
- free from cancer related pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LVA and liposuctionTumescent 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. | Procedure or surgery | – |
Primary outcome
Volume reduction of the limb
Time frame: one year after surgery
mesurement of volume reduction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Description of an Effective Surgical Strategy to Treat Cancer Related Lymphedema, a High Incidence Pathology, run by University of Siena at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume reduction of the limb (time frame: one year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.