Lymphovenous Anastomosis for Breast Cancer Lymphedema

Lymphovenous Anastomosis for Breast Cancer-related Lymphedema: A Cohort Study

This multi-center cohort study focuses on evaluating the efficacy of lymphovenous anastomosis (LVA) for treating pitting lymphedema in female breast cancer survivors. Conducted across multiple centers in Denmark, including Odense University Hospital, Herlev Hospital, Lillebaelt Hospital Vejle, and Zealand University Hospital, it aims to assess LVA's impact on reducing arm volume and improving quality of life in patients with upper extremity lymphedema secondary to breast cancer treatment.

Eligible participants are adult women with unilateral arm lymphedema who show active pitting and identifiable lymphatic vessels via indocyanine green lymphography. Inclusion involves informed consent and the ability to complete Danish questionnaires.

Patients are recruited from the outpatient clinics of the participating hospitals and will undergo LVA surgery under either local or general anesthesia. Following the intervention, patients are seen for data collection up to twelve months.

The study measures outcomes like arm volume changes through water displacement volumetry and arm circumferential measurements, body composition via bioimpedance, health-related quality of life through LYMPH-Q, general quality of life through SF-36, arm function via DASH, and anastomosis patency via ICG lymphography. Additionally, changes in ICG lymphography images, arm fibrosis via SkinFibroMeter, and surgery duration are evaluated.

The study adheres to ethical guidelines, ensuring patient safety and the integrity of the research.

Study Overview

• Status: Recruiting
• Conditions: Lymphedema; Breast Cancer Lymphedema; Lymphedema, Breast Cancer; Lymphedema of Upper Limb; Lymphedema, Secondary; Lymphedema Arm; Lymphedema; Surgical
• Intervention / Treatment: Procedure: Lymphovenous anastomosis (LVA)

Detailed Description

This comprehensive single-armed cohort study is dedicated to assessing the effectiveness of lymphovenous anastomosis (LVA) in treating pitting lymphedema among adult female patients who have undergone breast cancer treatment.

This study builds upon findings from our preliminary pilot study at Odense University Hospital, and is conducted across several hospitalt in Denmark, including Odense University Hospital, Lillebælt Hospital Vejle, Zealand University Hospital Roskilde, and Herlev Hospital.

The study's primary aim is to determine whether LVA can significantly reduce arm volume and improve the overall quality of life for patients afflicted with breast cancer-related lymphedema.

Inclusion Criteria and Patient Recruitment The study population consists of women over 18 years of age suffering from unilateral arm lymphedema secondary to breast cancer treatment. Key eligibility criteria include active pitting lymphedema, presence of dermal backflow as evidenced by indocyanine green lymphography, identifiable lymphatic vessels in the affected arm, and the ability to provide informed consent and complete questionnaires in Danish.

Prospective participants are identified during clinical assessments at the participating hospitals' Departments of Plastic Surgery. Those deemed suitable for LVA surgery by consulting surgeons are invited to participate, ensuring informed consent through both oral and written communication.

Method This multi-center cohort study employs a range of outcome measures to evaluate the impact of LVA surgery. Primary outcomes focus on changes in arm volume, measured through water displacement volumetry and arm circumferential measurements, employing the unaffected arm as a control.

Secondary outcomes include assessments of body composition via bioimpedance spectroscopy, health-related quality of life through the LYMPH-Q questionnaire, arm function via the DASH questionnaire, general quality of life via the SF-36 questionnaire, patency of anastomosis validated by ICG lymphography, changes in ICG lymphography images, and arm fibrosis measured with the SkinFibroMeter.

Data collected are entered into a secure database for analysis. This includes comparing pre- and postoperative measurements to assess the primary and secondary outcomes.

Surgical Procedure and Follow-up LVA surgeries are performed by surgeons at Odense University Hospital and Herlev Hospital, with the choice between local or general anesthesia based on the number of planned anastomoses and patient preference.

Patients will be seen prior to surgery for baseline measurements, in addition to six and twelve months post-operative follow-up. At three and nine months post-operative, phone consultations will be performed for reminders of questionnaires and patient safety.

The study prohibits participants from undergoing other medical or surgical treatments for lymphedema during the trial period, although conservative treatments like compression garments are accepted.

Data Management and Ethics Adhering to the ethical standards, this study complies with Good Clinical Practice, The Danish Code of Conduct for Research Integrity, and GDPR. It has sought approval from the Research Ethics Committee of the Region of Southern Denmark. Patient safety is paramount, with LVA considered a safe and valid treatment option.

Feasibility and Publication Led by Caroline Lilja, MD, and Ph.D. student, under the supervision of Jørn Bo Thomsen, Dr., MD., Ass. Prof., the study aims for results publication regardless of the outcome, emphasizing its contribution to the field and potential impact on treatment protocols for lymphedema patients.

• Study Type: Interventional
• Enrollment (Estimated): 47
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caroline Lilja, MD; Phone Number: +4560555340; Email: caroline.lilja@rsyd.dk

Study Locations

• Denmark
  • Region Of Southern Denmark
    • Odense, Region Of Southern Denmark, Denmark, 5000
      • Recruiting
      • Department of Plastic Surgery, Odense University Hospital
      • Contact: Caroline Lilja, MD; Phone Number: +4560555340; Email: caroline.lilja@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age >18
• Female
• Unilateral arm lymphedema secondary to breast-cancer treatment
• Active pitting lymphedema
• Presence of dermal backflow in indocyanine green lymphography
• Identifiable lymphatic vessel(s) in the affected arm using an infrared camera and indocyanin green
• Able to provide informed consent
• Able to read, understand and complete Danish questionnaires

Exclusion Criteria:

• Allergy to iodine
• Pregnant, breast-feeding, or aiming to conceive withing the next year
• History of bilateral breast cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lymphovenous anastomosis (LVA); Intervention with lymphovenous anastomosis (LVA) surgery of the affected arm.	Procedure: Lymphovenous anastomosis (LVA); Surgical procedure with supermicrosurgical anastomosis between distal lymph vessel and proximal venule.; Other Names: Lymphaticovenular anastomosis; Lymphovenous bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arm volume (Water Displacement)	Changes of arm volume difference	Baseline, six months, twelve months
Arm volume (Arm Circumferences)	Changes of arm volume difference	Baseline, six months, twelve months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life (LYMPH-Q)	Changes of health-related quality of life, measured with LYMPH-Q	baseline, three months, six months, nine months, twelve months
General quality of life (SF-36)	Changes of health-related quality of life measured with SF-36	baseline, three months, six months, nine months, twelve months
Arm and shoulder function (DASH)	Changes in arm and shoulder function, measured with DASH	baseline, three months, six months, nine months, twelve months
L-Dex	Changes in L-Dex score	Baseline, six months, twelve months
LVA patency	Evaluation of patency using indocyanine green lymphography postoperatively. Number of patent anastomosis will be compared to number performed during surgery.	Baseline, six months
Skin Fibrosis	The degree of skin fibrosis measured with SkinFibroMeter	Baseline, six months, twelve months
Surgery duration	The duration of surgery will be compared between sites	Day of intervention
Body composition	Changes in body compositions measured with SoZo bioimpedance will be evaluated.	Baseline, six months, twelve months

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: Zealand University Hospital; Vejle Hospital; Herlev and Gentofte Hospital
• Investigators: Principal Investigator: Caroline Lilja, MD, Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Postoperative Complications; Breast Diseases; Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema
• Other Study ID Numbers: 23/54225

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No