Breast Cancer LymphedemaNCT05441943
Lymphaticovenous Anastomosis as Treatment for Lymphedema
A study testing Lymphovenous anastomosis in people with Breast Cancer Lymphedema and Secondary Lymphedema, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The primary aim of this study is to investigate and test whether the use of combined indocyanine green (ICG) lymphography and ultra high frequency ultrasonography can correctly identify lymphatic vessels and venoles in close proximity to each other, for identification prior to lymphovenous anastomosis (LVA) surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Lymphedema, Secondary Lymphedema, Iatrogenic Lymphedema
- What is being tested?
- Lymphovenous anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 11 May 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Iatrogenic lymphedema following treatment for breast cancer in upper extremity
- Possible to obtain informed consent
- Age>18
Who cannot join
- Duration of disease over 24 months
- Smoker
- Untreated or uncontrolled primary cancer
- No applicable lymphatic vessels identified, using ICG lymphangiography
- No applicable venous vessels identified using ultra high frequency ultrasound
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Plastic Surgery, Odense University Hospital
Odense, Region Syddanmark, 5000
About this study
Official title: Lymphaticovenous Anastomosis as a Surgical Treatment for Breast Cancer-Related Lymphedema
The primary aim of this study is to investigate and test whether the use of combined indocyanine green (ICG) lymphography and ultra high frequency ultrasonography can correctly identify lymphatic vessels and venoles in close proximity to each other, for identification prior to lymphovenous anastomosis (LVA) surgery.
Read the detailed description
BACKGROUND
Breast-cancer related lymphedema is a life-disabling side-effect of breast cancer treatment, affecting more than 1 in every 5 patients. With breast-cancer being the most common cancer diagnosis in women, affecting up to 2.3 million new cases globally, and with a generally high survival rate of 80% or higher in developed countries, the number of breast-cancer survivors with long-term sequela is significant. Compression garments have been considered the standard treatment and rehabilitation for lymphedema. Some of the disadvantages with these treatments include variability in patient compliance, clinical effect and lack of statistical significant results. Therefore, the rehabilitation and treatment options for lymphedema are in high demand, affecting patients physical and mental health.
Lymphovenous anastomosis (LVA) surgery is an attempt to re-establish the lymphatic flow, utilizing the patient's own lymphatic- and venous vessels. Surgical treatment seems effective in selective patient groups, but systematic studies for this are lacking. It is based on this lack of knowledge of patient characteristics and preoperative planning that the project's hypothesis and idea was formed.
Indocyanine green (ICG) lymphography is commonly used for identification of lymphatic vessels pre-operatively, and is considered superior to other modalities. However, until recently, the identification of adjacent venoles has remained a challenge. Ultra high frequency ultrasound may have solved the challenge of identifying the small venoles prior to surgery. The combined use of ICG lymphography and ultra high frequency ultrasound may be the key to optimise patient selection and pre-operative planning of lymphovenous anastomosis surgery.
METHOD
This study is designed as a pilot study with a planned inclusion of 10 patients with a 3 months follow-up period.
The inclusion of patients, the surgical procedure and 3 months follow-up evaluation will take place at the Department of Plastic Surgery Odense University Hospital (OUH), Denmark.
The ICG lymphography is performed by injecting ICG subcutaneously, and used for visualization of the superficial lymphatics for preoperative planning. During real-time visualization, lymphatic vessels are drawn up on the patients arm using a permanent marker.
Ultra high frequency ultrasound (>30MHz) has the ability to visualize small, superficial anatomical layers. Using this ultra high frequency ultrasound (70MHz), following the mapped lymphatic vessels, venous vessels are found nearby and likewise mapped for anastomosis.
The number of LVA anastomosis sites is set to a minimum of two sites per extremity. The number of mapped lymphatics vessels and venoles are compared to the number identified during surgery and recorded.
Prior to and 3 months after surgery, patients are seen for objective measures of upper extremity volume, body composition, L-Dex score of the affected arm and health-related quality-of-life, in addition to ICG lymphography.
- Conditions
- Breast Cancer Lymphedema, Secondary Lymphedema, Iatrogenic Lymphedema, Lymphedema, Lymphedema of Upper Limb, Lymphedema Arm
- Being tested
- Lymphovenous anastomosis
- Keywords
- Lymphedema, Breast Cancer, Postmastectomy Lymphedema, Lymphoedema, Breast Cancer Lymphedema, Anastomose, Lymphovenous anastomosis, LVA, Surgery, Breast Neoplasm
- Medical subject headings
- Breast Cancer Lymphedema, Lymphedema, Breast Neoplasms, Neoplasms, Breast Diseases, Lymphatic Diseases, Skin Diseases, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymphovenous anastomosisProcedure or surgery
Also called LVA, Lymphaticovenous anastomosis, Lymphaticovenular anastomosis
Pre-operative planning prior to lymphovenous anastomosis using ICG lymphography and ultra high frequency ultrasound for mapping of applicable vessels.
During surgery, mapped vessels are freely dissected and anastomosed.
| Study group | Role | What they receive |
|---|---|---|
| Lymphovenous anastomosis surgery | Experimental | Lymphovenous anastomosis surgery with pre-operative planning using ICG lymphography and ultra high frequency ultrasound. Receives: Procedure: Lymphovenous anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of vessels planned for surgery surgery
The number of mapped lymphatics vessels and venoles.
Measured: Preoperative
Number of vessels found during surgery
The number of vessels found during surgery. This number will be compared to the number of vessels planned for surgery.
Measured: Perioprative
Secondary outcomes (11)
Changes of arm volume
The change of arm volume difference at baseline and at three months follow-up after surgery.
Volume calculation Manual circumferential measurements are taken from both arms for volume calculation, based on the formula for multiple blunt cones.
Water displacement for volume assessment The water displacement test estimates the volume of the arm, based on lowering the extremity in a basin of water, and calculating the water volume difference in mL. Both extremities are measured.
Measured: Baseline and 3 months follow-up
Change of extracellular fluid (liters) relative to total body water (liters), measured in percentage.
The change in extracellular fluid (liters), relative to total body water (liters), measured by a stand-on bioimpedance at baseline and 3 months follow-up. The stand-on device measure the body composition through small electric impulses between two electrodes.
Extracellular fluid and total body water measures will be aggregated to one reported value (extracellular fluid (liters) / total body water (liters)).
Measured: Baseline and 3 months follow-up
Changes of intracellular fluid (liters) relative to total body water (liters), measured in percentage.
The change in intracellular fluid (liters), relative to body water (liters), measured by a stand-on bioimpedance at baseline and 3 months follow-up. The stand-on device measure the body composition through small electric impulses between two electrodes.
Intracellular fluid and total body water measures will be aggregated to one reported value (intracellular fluid (liters) / total body water (liters)).
Measured: Baseline and 3 months follow-up
Changes of total body water (liters) relative to weight (kg), measured in percentage.
The change in total body water (liters), relative to body weight (kg), measured by a stand-on bioimpedance at baseline and 3 months follow-up. The stand-on device measure the body composition through small electric impulses between two electrodes.
Total body water and weight measures will be aggregated to one reported value (total body water (liters) / weight (kg)).
Measured: Baseline and 3 months follow-up
Changes of proteins and minerals (kg) relative to weight (kg), measured in percentage.
The change in proteins and minerals (kg), relative to body weight (kg), measured by a stand-on bioimpedance at baseline and 3 months follow-up. The stand-on device measure the body composition through small electric impulses between two electrodes.
Proteins and minerals and weight measures will be aggregated to one reported value (proteins and minerals (kg) / weight (kg)).
Measured: Baseline and 3 months follow-up
Changes of fat mass (kg) relative to weight (kg), measured in percentage.
The change in fat mass (kg), relative to body weight (kg), measured by a stand-on bioimpedance at baseline and 3 months follow-up. The stand-on device measure the body composition through small electric impulses between two electrodes.
Fat mass and weight measures will be aggregated to one reported value (fat mass (kg) / weight (kg)).
Measured: Baseline and 3 months follow-up
Changes in active tissue mass (kg) relative to weight (kg), measured in percentage.
The change in active tissue mass (kg), relative to body weight (kg), measured by a stand-on bioimpedance at baseline and 3 months follow-up. The stand-on device measure the body composition through small electric impulses between two electrodes.
Active tissue mass and weight measures will be aggregated to one reported value (active tissue mass (kg) / weight (kg)).
Measured: Baseline and 3 months follow-up
Changes of skeletal muscle mass (kg) relative to weight (kg), measured in percentage.
The change in skeletal muscle mass (kg), relative to body weight (kg), measured by a stand-on bioimpedance at baseline and 3 months follow-up. The stand-on device measure the body composition through small electric impulses between two electrodes.
Skeletal muscle mass and weight measures will be aggregated to one reported value (skeletal muscle mass (kg) / weight (kg)).
Measured: Baseline and 3 months follow-up
Changes in L-Dex score
L-Dex score is a measurement of extracellular fluid of the arm. A stand-on bioimpedance device, estimates the extracellular fluid trough electric impulses between its electrodes. Based upon the impedance ratio of the affected and unaffected arm, the bioimpedance calculates a Lymphedema index, called L-Dex ratio score. A number between -10 and 10 is considered normal, and diagnostic for lymphedema if above 10. Its sensitivity and specificity are 0.66 and 0.99, respectively, at a receiver operating characteristic curve (ROC) value of 10. The score correlates with the limb volume and lymphatic function.
Measured: Baseline and 3 months follow-up
Changes in health-related quality-of-life measured by the LYMPH-Q questionnaire
The LYMPH-Q Upper extremity module questionnaire is a validated patient-reported outcome tool for women with breast cancer related lymphedema. The module contains seven individual scales, measuring: symptoms, function, appearance, psychological function, and satisfaction with information on lymphedema and satisfaction with arm sleeve. Each scale gives an independent score reaching from 0 (worst) to 100 (best), which can be used for comparison of change over time. A higher score indicates a better outcome.
Patients will complete the questionnaire at baseline and 3 months follow-up.
Measured: Baseline and 3 months follow-up
Changes of lymphatic flow pattern before and after surgery by ICG lymphangiography
Video recordings of ICG lymphographies are stored for later classification of the lymphedema. Staging will be done using the MD Anderson scale; a classification system based upon pattern recognition of the dermal backflow from the ICG lymphography, see table 1.
MD Anderson stage ICG lymphography findings Stage 0 No dermal backflow Stage 1 Many patent lymphatics and minimal dermal backflow Stage 2 Moderate number of patent lymphatics and segmental dermal backflow Stage 3 Few patent lymphatics with extensive dermal backflow Stage 4 Dermal backflow involving the hand Stage 5 ICG does not move proximally to injection site Table 1: MD Anderson classification based upon ICG lymphography findings.
Measured: Baseline and 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start11 May 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer LymphedemaStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society
- Responsible party
- Principal investigator, Caroline Lilja, Odense University Hospital
- Investigators
- Caroline Lilja, MD, Principal investigator, Department of Plastic Surgery at Odense University HospitalJens Ahm Sørensen, MD, Prof, PhD, Study chair, Department of Plastic Surgery at Odense University HospitalJørn Bo Thomsen, MD, Prof, PhD, Study chair, Department of Plastic Surgery at Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441943
- Sponsor's protocol ID
- 21/59848
- Other IDs
- S-20210169
- Status last verified
- Mar 2024
- First submitted
- 7 Jun 2022
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Armer JM, Ballman KV, McCall L, Armer NC, Sun Y, Udmuangpia T, Hunt KK, Mittendorf EA, Byrd DR, Julian TB, Boughey JC. Lymphedema symptoms and limb measurement changes in breast cancer survivors treated with neoadjuvant chemotherapy and axillary dissection: results of American College of Surgeons Oncology Group (ACOSOG) Z1071 (Alliance) substudy. Support Care Cancer. 2019 Feb;27(2):495-503. doi: 10.1007/s00520-018-4334-7. Epub 2018 Jul 6.
PubMed 29980907DiSipio T, Rye S, Newman B, Hayes S. Incidence of unilateral arm lymphoedema after breast cancer: a systematic review and meta-analysis. Lancet Oncol. 2013 May;14(6):500-15. doi: 10.1016/S1470-2045(13)70076-7. Epub 2013 Mar 27.
PubMed 23540561Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338Maajani K, Jalali A, Alipour S, Khodadost M, Tohidinik HR, Yazdani K. The Global and Regional Survival Rate of Women With Breast Cancer: A Systematic Review and Meta-analysis. Clin Breast Cancer. 2019 Jun;19(3):165-177. doi: 10.1016/j.clbc.2019.01.006. Epub 2019 Jan 29.
PubMed 30952546Markkula SP, Leung N, Allen VB, Furniss D. Surgical interventions for the prevention or treatment of lymphoedema after breast cancer treatment. Cochrane Database Syst Rev. 2019 Feb 19;2(2):CD011433. doi: 10.1002/14651858.CD011433.pub2.
PubMed 30779124Drobot A, Bez M, Abu Shakra I, Merei F, Khatib K, Bickel A, Ganam S, Bogouslavski G, Karra N, Mahran B, Kassis W, Kogan L, Drobot D, Weiss M, Koshima I, Kakiashvili E. Microsurgery for management of primary and secondary lymphedema. J Vasc Surg Venous Lymphat Disord. 2021 Jan;9(1):226-233.e1. doi: 10.1016/j.jvsv.2020.04.025. Epub 2020 May 21.
PubMed 32446874Seki Y, Kajikawa A, Yamamoto T, Takeuchi T, Terashima T, Kurogi N. The dynamic-lymphaticovenular anastomosis method for breast cancer treatment-related lymphedema: Creation of functional lymphaticovenular anastomoses with use of preoperative dynamic ultrasonography. J Plast Reconstr Aesthet Surg. 2019 Jan;72(1):62-70. doi: 10.1016/j.bjps.2018.09.005. Epub 2018 Sep 20.
PubMed 30292697Brahma B, Putri RI, Reuwpassa JO, Tuti Y, Alifian MF, Sofyan RF, Iskandar I, Yamamoto T. Lymphaticovenular Anastomosis in Breast Cancer Treatment-Related Lymphedema: A Short-Term Clinicopathological Analysis from Indonesia. J Reconstr Microsurg. 2021 Oct;37(8):643-654. doi: 10.1055/s-0041-1723940. Epub 2021 Mar 1.
PubMed 33648010Wolfs JAGN, de Joode LGEH, van der Hulst RRWJ, Qiu SS. Correlation between patency and clinical improvement after lymphaticovenous anastomosis (LVA) in breast cancer-related lymphedema: 12-month follow-up. Breast Cancer Res Treat. 2020 Jan;179(1):131-138. doi: 10.1007/s10549-019-05450-2. Epub 2019 Sep 21.
PubMed 31542874Jorgensen MG, Toyserkani NM, Hansen FG, Bygum A, Sorensen JA. The impact of lymphedema on health-related quality of life up to 10 years after breast cancer treatment. NPJ Breast Cancer. 2021 Jun 1;7(1):70. doi: 10.1038/s41523-021-00276-y.
PubMed 34075045Kibar S, Dalyan Aras M, Unsal Delialioglu S. The risk factors and prevalence of upper extremity impairments and an analysis of effects of lymphoedema and other impairments on the quality of life of breast cancer patients. Eur J Cancer Care (Engl). 2017 Jul;26(4). doi: 10.1111/ecc.12433. Epub 2016 Jan 13.
PubMed 26764197Ahmed RL, Prizment A, Lazovich D, Schmitz KH, Folsom AR. Lymphedema and quality of life in breast cancer survivors: the Iowa Women's Health Study. J Clin Oncol. 2008 Dec 10;26(35):5689-96. doi: 10.1200/JCO.2008.16.4731. Epub 2008 Nov 10.
PubMed 19001331Gillespie TC, Sayegh HE, Brunelle CL, Daniell KM, Taghian AG. Breast cancer-related lymphedema: risk factors, precautionary measures, and treatments. Gland Surg. 2018 Aug;7(4):379-403. doi: 10.21037/gs.2017.11.04.
PubMed 30175055Chang EI, Skoracki RJ, Chang DW. Lymphovenous Anastomosis Bypass Surgery. Semin Plast Surg. 2018 Feb;32(1):22-27. doi: 10.1055/s-0038-1636510. Epub 2018 Apr 9.
PubMed 29636650Mihara M, Hara H, Araki J, Kikuchi K, Narushima M, Yamamoto T, Iida T, Yoshimatsu H, Murai N, Mitsui K, Okitsu T, Koshima I. Indocyanine green (ICG) lymphography is superior to lymphoscintigraphy for diagnostic imaging of early lymphedema of the upper limbs. PLoS One. 2012;7(6):e38182. doi: 10.1371/journal.pone.0038182. Epub 2012 Jun 4.
PubMed 22675520
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymphaticovenous Anastomosis as a Surgical Treatment for Breast Cancer-Related Lymphedema
- ClinicalTrials.gov ID
- NCT05441943
- Acronym / sponsor ID
- 21/59848
- Conditions
- Breast Cancer Lymphedema, Secondary Lymphedema, Iatrogenic Lymphedema, Lymphedema, Lymphedema of Upper Limb, Lymphedema Arm
- Keywords
- Lymphedema, Breast Cancer, Postmastectomy Lymphedema, Lymphoedema, Breast Cancer Lymphedema, Anastomose, Lymphovenous anastomosis, LVA
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- 11 May 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Jul 2022 (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.
The primary aim of this study is to investigate and test whether the use of combined indocyanine green (ICG) lymphography and ultra high frequency ultrasonography can correctly identify lymphatic vessels and venoles in close proximity to each other, for identification prior to lymphovenous anastomosis (LVA) surgery.
Detailed description
BACKGROUND
Breast-cancer related lymphedema is a life-disabling side-effect of breast cancer treatment, affecting more than 1 in every 5 patients. With breast-cancer being the most common cancer diagnosis in women, affecting up to 2.3 million new cases globally, and with a generally high survival rate of 80% or higher in developed countries, the number of breast-cancer survivors with long-term sequela is significant. Compression garments have been considered the standard treatment and rehabilitation for lymphedema. Some of the disadvantages with these treatments include variability in patient compliance, clinical effect and lack of statistical significant results. Therefore, the rehabilitation and treatment options for lymphedema are in high demand, affecting patients physical and mental health.
Lymphovenous anastomosis (LVA) surgery is an attempt to re-establish the lymphatic flow, utilizing the patient's own lymphatic- and venous vessels. Surgical treatment seems effective in selective patient groups, but systematic studies for this are lacking. It is based on this lack of knowledge of patient characteristics and preoperative planning that the project's hypothesis and idea was formed.
Indocyanine green (ICG) lymphography is commonly used for identification of lymphatic vessels pre-operatively, and is considered superior to other modalities. However, until recently, the identification of adjacent venoles has remained a challenge. Ultra high frequency ultrasound may have solved the challenge of identifying the small venoles prior to surgery. The combined use of ICG lymphography and ultra high frequency ultrasound may be the key to optimise patient selection and pre-operative planning of lymphovenous anastomosis surgery.
METHOD
This study is designed as a pilot study with a planned inclusion of 10 patients with a 3 months follow-up period.
The inclusion of patients, the surgical procedure and 3 months follow-up evaluation will take place at the Department of Plastic Surgery Odense University Hospital (OUH), Denmark.
The ICG lymphography is performed by injecting ICG subcutaneously, and used for visualization of the superficial lymphatics for preoperative planning. During real-time visualization, lymphatic vessels are drawn up on the patients arm using a permanent marker.
Ultra high frequency ultrasound (>30MHz) has the ability to visualize small, superficial anatomical layers. Using this ultra high frequency ultrasound (70MHz), following the mapped lymphatic vessels, venous vessels are found nearby and likewise mapped for anastomosis.
The number of LVA anastomosis sites is set to a minimum of two sites per extremity. The number of mapped lymphatics vessels and venoles are compared to the number identified during surgery and recorded.
Prior to and 3 months after surgery, patients are seen for objective measures of upper extremity volume, body composition, L-Dex score of the affected arm and health-related quality-of-life, in addition to ICG lymphography.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lymphovenous anastomosis surgery | Experimental | Procedure: Lymphovenous anastomosisLymphovenous anastomosis surgery with pre-operative planning using ICG lymphography and ultra high frequency ultrasound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- Iatrogenic lymphedema following treatment for breast cancer in upper extremity
- Possible to obtain informed consent
- Age>18
Key exclusion criteria (5 listed)
- Duration of disease over 24 months
- Smoker
- Untreated or uncontrolled primary cancer
- No applicable lymphatic vessels identified, using ICG lymphangiography
- No applicable venous vessels identified using ultra high frequency ultrasound
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 |
|---|---|---|
| Lymphovenous anastomosisAlso: LVA, Lymphaticovenous anastomosis, Lymphaticovenular anastomosisPre-operative planning prior to lymphovenous anastomosis using ICG lymphography and ultra high frequency ultrasound for mapping of applicable vessels. During surgery, mapped vessels are freely dissected and anastomosed. | Procedure or surgery | Lymphovenous anastomosis surgery |
Primary outcome
Number of vessels planned for surgery surgery
Time frame: Preoperative
The number of mapped lymphatics vessels and venoles.
Number of vessels found during surgery
Time frame: Perioprative
The number of vessels found during surgery. This number will be compared to the number of vessels planned for surgery.
11 secondary outcomes
Changes of arm volume
Time frame: Baseline and 3 months follow-up
Change of extracellular fluid (liters) relative to total body water (liters), measured in percentage.
Time frame: Baseline and 3 months follow-up
Changes of intracellular fluid (liters) relative to total body water (liters), measured in percentage.
Time frame: Baseline and 3 months follow-up
Changes of total body water (liters) relative to weight (kg), measured in percentage.
Time frame: Baseline and 3 months follow-up
Changes of proteins and minerals (kg) relative to weight (kg), measured in percentage.
Time frame: Baseline and 3 months follow-up
Changes of fat mass (kg) relative to weight (kg), measured in percentage.
Time frame: Baseline and 3 months follow-up
Changes in active tissue mass (kg) relative to weight (kg), measured in percentage.
Time frame: Baseline and 3 months follow-up
Changes of skeletal muscle mass (kg) relative to weight (kg), measured in percentage.
Time frame: Baseline and 3 months follow-up
Changes in L-Dex score
Time frame: Baseline and 3 months follow-up
Changes in health-related quality-of-life measured by the LYMPH-Q questionnaire
Time frame: Baseline and 3 months follow-up
Changes of lymphatic flow pattern before and after surgery by ICG lymphangiography
Time frame: Baseline and 3 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Background: PubMed 29980907Armer JM, Ballman KV, McCall L, Armer NC, Sun Y, Udmuangpia T, Hunt KK, Mittendorf EA, Byrd DR, Julian TB, Boughey JC. Lymphedema symptoms and limb measurement changes in breast cancer survivors treated with neoadjuvant chemotherapy and axillary dissection: results of American College of Surgeons Oncology Group (ACOSOG) Z1071 (Alliance) substudy. Support Care Cancer. 2019 Feb;27(2):495-503. doi: 10.1007/s00520-018-4334-7. Epub 2018 Jul 6.
- Background: PubMed 23540561DiSipio T, Rye S, Newman B, Hayes S. Incidence of unilateral arm lymphoedema after breast cancer: a systematic review and meta-analysis. Lancet Oncol. 2013 May;14(6):500-15. doi: 10.1016/S1470-2045(13)70076-7. Epub 2013 Mar 27.
- Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Background: PubMed 30952546Maajani K, Jalali A, Alipour S, Khodadost M, Tohidinik HR, Yazdani K. The Global and Regional Survival Rate of Women With Breast Cancer: A Systematic Review and Meta-analysis. Clin Breast Cancer. 2019 Jun;19(3):165-177. doi: 10.1016/j.clbc.2019.01.006. Epub 2019 Jan 29.
- Background: PubMed 30779124Markkula SP, Leung N, Allen VB, Furniss D. Surgical interventions for the prevention or treatment of lymphoedema after breast cancer treatment. Cochrane Database Syst Rev. 2019 Feb 19;2(2):CD011433. doi: 10.1002/14651858.CD011433.pub2.
- Background: PubMed 32446874Drobot A, Bez M, Abu Shakra I, Merei F, Khatib K, Bickel A, Ganam S, Bogouslavski G, Karra N, Mahran B, Kassis W, Kogan L, Drobot D, Weiss M, Koshima I, Kakiashvili E. Microsurgery for management of primary and secondary lymphedema. J Vasc Surg Venous Lymphat Disord. 2021 Jan;9(1):226-233.e1. doi: 10.1016/j.jvsv.2020.04.025. Epub 2020 May 21.
- Background: PubMed 30292697Seki Y, Kajikawa A, Yamamoto T, Takeuchi T, Terashima T, Kurogi N. The dynamic-lymphaticovenular anastomosis method for breast cancer treatment-related lymphedema: Creation of functional lymphaticovenular anastomoses with use of preoperative dynamic ultrasonography. J Plast Reconstr Aesthet Surg. 2019 Jan;72(1):62-70. doi: 10.1016/j.bjps.2018.09.005. Epub 2018 Sep 20.
- Background: PubMed 33648010Brahma B, Putri RI, Reuwpassa JO, Tuti Y, Alifian MF, Sofyan RF, Iskandar I, Yamamoto T. Lymphaticovenular Anastomosis in Breast Cancer Treatment-Related Lymphedema: A Short-Term Clinicopathological Analysis from Indonesia. J Reconstr Microsurg. 2021 Oct;37(8):643-654. doi: 10.1055/s-0041-1723940. Epub 2021 Mar 1.
- Background: PubMed 31542874Wolfs JAGN, de Joode LGEH, van der Hulst RRWJ, Qiu SS. Correlation between patency and clinical improvement after lymphaticovenous anastomosis (LVA) in breast cancer-related lymphedema: 12-month follow-up. Breast Cancer Res Treat. 2020 Jan;179(1):131-138. doi: 10.1007/s10549-019-05450-2. Epub 2019 Sep 21.
- Background: PubMed 34075045Jorgensen MG, Toyserkani NM, Hansen FG, Bygum A, Sorensen JA. The impact of lymphedema on health-related quality of life up to 10 years after breast cancer treatment. NPJ Breast Cancer. 2021 Jun 1;7(1):70. doi: 10.1038/s41523-021-00276-y.
- Background: PubMed 26764197Kibar S, Dalyan Aras M, Unsal Delialioglu S. The risk factors and prevalence of upper extremity impairments and an analysis of effects of lymphoedema and other impairments on the quality of life of breast cancer patients. Eur J Cancer Care (Engl). 2017 Jul;26(4). doi: 10.1111/ecc.12433. Epub 2016 Jan 13.
- Background: PubMed 19001331Ahmed RL, Prizment A, Lazovich D, Schmitz KH, Folsom AR. Lymphedema and quality of life in breast cancer survivors: the Iowa Women's Health Study. J Clin Oncol. 2008 Dec 10;26(35):5689-96. doi: 10.1200/JCO.2008.16.4731. Epub 2008 Nov 10.
- Will, P.A., Wan, Z., Seide, S.E. et al. Supermicrosurgical treatment for lymphedema: a systematic review and network meta-analysis protocol. Syst Rev 11, 18 (2022). https://doi.org/10.1186/s13643-022-01885-9Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Caroline Lilja, MD principal investigator
Department of Plastic Surgery at Odense University Hospital
Jens Ahm Sørensen, MD, Prof, PhD study chair
Department of Plastic Surgery at Odense University Hospital
Jørn Bo Thomsen, MD, Prof, PhD study chair
Department of Plastic Surgery at Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymphovenous anastomosis in people with Breast Cancer Lymphedema and Secondary Lymphedema, run by Odense University Hospital at 1 site in Denmark.
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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2024. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of vessels planned for surgery surgery (time frame: Preoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05441943, which also lists 32 linked publications.
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 5 Mar 2024.