Lymphovenous Anastomosis for Breast Cancer Lymphedema

NCT ID: NCT06302361

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2026-06-30

Brief Summary

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.

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.

Conditions

Lymphedema; Lymphedema Arm; Breast Cancer Lymphedema; Lymphedema, Secondary; Lymphedema; Surgical; Lymphedema of Upper Limb; Lymphedema, Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lymphovenous anastomosis (LVA)

Intervention with lymphovenous anastomosis (LVA) surgery of the affected arm.

Group Type: EXPERIMENTAL

Lymphovenous anastomosis (LVA)

Intervention Type: PROCEDURE

Surgical procedure with supermicrosurgical anastomosis between distal lymph vessel and proximal venule.

Interventions

Lymphovenous anastomosis (LVA)

Surgical procedure with supermicrosurgical anastomosis between distal lymph vessel and proximal venule.

Intervention Type: PROCEDURE

Other Intervention Names

Lymphovenous bypass; Lymphaticovenular anastomosis

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Vejle Hospital

OTHER

Sponsor Role: collaborator

Zealand University Hospital

OTHER

Sponsor Role: collaborator

Herlev and Gentofte Hospital

OTHER

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Caroline Lilja

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Caroline Lilja, MD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

Department of Plastic Surgery, Odense University Hospital

Odense, Region Syddanmark, Denmark

Countries

Denmark

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

23/54225

Identifier Type: -

Identifier Source: org_study_id