Back to resultsLymphaticovenous Anastomosis as Treatment for Lymphedema
Primary Purpose
Breast Cancer Lymphedema, Secondary Lymphedema, Iatrogenic Lymphedema
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Lymphovenous anastomosis
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer Lymphedema focused on measuring Lymphedema, Breast Cancer, Postmastectomy Lymphedema, Lymphoedema, Breast Cancer Lymphedema, Anastomose, Lymphovenous anastomosis, LVA, Surgery, Breast Neoplasm
Eligibility Criteria
Inclusion Criteria:
- Female
- Iatrogenic lymphedema following treatment for breast cancer in upper extremity
- Possible to obtain informed consent
- Age>18
Exclusion Criteria:
- 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
Sites / Locations
- Department of Plastic Surgery, Odense University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lymphovenous anastomosis surgery
Arm Description
Lymphovenous anastomosis surgery with pre-operative planning using ICG lymphography and ultra high frequency ultrasound.
Outcomes
Primary Outcome Measures
Number of vessels planned for surgery surgery
The number of mapped lymphatics vessels and venoles.
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.
Secondary Outcome Measures
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.
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)).
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)).
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)).
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)).
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)).
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)).
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)).
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.
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.
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.
Full Information
NCT ID
NCT05441943
First Posted
June 7, 2022
Last Updated
June 28, 2022
Sponsor
Odense University Hospital
Collaborators
Danish Cancer Society
1. Study Identification
Unique Protocol Identification Number
NCT05441943
Brief Title
Lymphaticovenous Anastomosis as Treatment for Lymphedema
Official Title
Lymphaticovenous Anastomosis as a Surgical Treatment for Breast Cancer-Related Lymphedema
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 2022 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
Collaborators
Danish Cancer Society
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Lymphedema, Secondary Lymphedema, Iatrogenic Lymphedema, Lymphedema, Lymphedema of Upper Limb, Lymphedema Arm, Lymphedema, Breast Cancer, Breast Neoplasm, Neoplasms, Breast Cancer, Breast Diseases, Lymphatic Diseases, Skin Diseases, Postoperative Complications, Pathologic Processes, Anastomose, Surgery, Surgical; Lymphedema, Postmastectomy, Postmastectomy Lymphedema, Postmastectomy Lymphedema Syndrome Left Upper Limb, Postmastectomy Lymphedema Syndrome Right Upper Limb, Postmastectomy Lymphedema Syndrome
Keywords
Lymphedema, Breast Cancer, Postmastectomy Lymphedema, Lymphoedema, Breast Cancer Lymphedema, Anastomose, Lymphovenous anastomosis, LVA, Surgery, Breast Neoplasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lymphovenous anastomosis surgery
Arm Type
Experimental
Arm Description
Lymphovenous anastomosis surgery with pre-operative planning using ICG lymphography and ultra high frequency ultrasound.
Intervention Type
Procedure
Intervention Name(s)
Lymphovenous anastomosis
Other Intervention Name(s)
LVA, Lymphaticovenous anastomosis, Lymphaticovenular anastomosis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of vessels planned for surgery surgery
Description
The number of mapped lymphatics vessels and venoles.
Time Frame
Preoperative
Title
Number of vessels found during surgery
Description
The number of vessels found during surgery. This number will be compared to the number of vessels planned for surgery.
Time Frame
Perioprative
Secondary Outcome Measure Information:
Title
Changes of arm volume
Description
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.
Time Frame
Baseline and 3 months follow-up
Title
Change of extracellular fluid (liters) relative to total body water (liters), measured in percentage.
Description
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)).
Time Frame
Baseline and 3 months follow-up
Title
Changes of intracellular fluid (liters) relative to total body water (liters), measured in percentage.
Description
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)).
Time Frame
Baseline and 3 months follow-up
Title
Changes of total body water (liters) relative to weight (kg), measured in percentage.
Description
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)).
Time Frame
Baseline and 3 months follow-up
Title
Changes of proteins and minerals (kg) relative to weight (kg), measured in percentage.
Description
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)).
Time Frame
Baseline and 3 months follow-up
Title
Changes of fat mass (kg) relative to weight (kg), measured in percentage.
Description
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)).
Time Frame
Baseline and 3 months follow-up
Title
Changes in active tissue mass (kg) relative to weight (kg), measured in percentage.
Description
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)).
Time Frame
Baseline and 3 months follow-up
Title
Changes of skeletal muscle mass (kg) relative to weight (kg), measured in percentage.
Description
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)).
Time Frame
Baseline and 3 months follow-up
Title
Changes in L-Dex score
Description
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.
Time Frame
Baseline and 3 months follow-up
Title
Changes in health-related quality-of-life measured by the LYMPH-Q questionnaire
Description
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.
Time Frame
Baseline and 3 months follow-up
Title
Changes of lymphatic flow pattern before and after surgery by ICG lymphangiography
Description
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.
Time Frame
Baseline and 3 months follow-up
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female
Iatrogenic lymphedema following treatment for breast cancer in upper extremity
Possible to obtain informed consent
Age>18
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Lilja, stud.med.
Phone
004560555340
Email
caroline.lilja@rsyd.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline Lilja, stud.med.
Organizational Affiliation
Department of Plastic Surgery at Odense University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jens Ahm Sørensen, MD Prof. PhD
Organizational Affiliation
Department of Plastic Surgery at Odense University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jørn Bo Thomsen, MD, PhD
Organizational Affiliation
Department of Plastic Surgery at Odense University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Plastic Surgery, Odense University Hospital
City
Odense
State/Province
Region Of Southern Denmark
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Lilja, stud.med.
Phone
+4560555340
Email
caroline.lilja@rsyd.dk
12. IPD Sharing Statement
Plan to Share IPD
No
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Links:
URL
https://rdcu.be/cO8Yo
Description
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/s13643-022-01885-9
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Lymphaticovenous Anastomosis as Treatment for Lymphedema
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