Effectiveness and Cost-effectiveness of Lymphaticovenous Anastomosis for Cancer Patients Who Suffer From Chronic Peripheral Lymphedema: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 3
- 主要终点
- Change from Baseline in the Lymph-ICF Score at 12 and 24 months
研究概览
简要总结
The goal of this randomized controlled trial is to compare the effectiveness and cost-effectiveness of lymphaticovenous anastomosis (LVA) with sham surgery for patients suffering from unilateral cancer-related lymphedema in either the upper or lower extremity. It aims to answer whether LVA is more effective than sham surgery in terms of improvement in Lymph-ICF score.
A total of 110 participants will be allocated randomly into two groups at a 1:1 ratio. The first group will receive lymphaticovenous anastomosis (LVA), while the second group will undergo sham surgery.
详细描述
One of the most debilitating side effects of cancer treatment is cancer-related lymphedema (CRL), with an overall incidence of 15.5%. To date, there is no definite cure for lymphedema. Conservative therapy, namely complex decongestive therapy is the golden standard for the treatment. Lymphaticovenous anastomosis (LVA) might be a promising treatment modality for patients with CRL, but available studies are small and the quality is lacking. No large-scale prospective or randomized studies have been published on the efficacy of LVA.
The main objective of this randomized controlled trial is to assess whether LVA is more effective than sham surgery in terms of improvement in Lymph-ICF score, volume reduction, reduction of complex decongestive therapy, and cost-effectiveness.
The study will take place in three centers in the Netherlands: Maastricht University Medical Center, Radboud University Medical Center, and Erasmus University Medical Center.
The patients will be randomly distributed into two groups: the LVA group or the Sham group. Both procedures are performed under local anesthesia. Patients in both groups are subject to minor surgical complications (wound infection, bleeding, wound dehiscence). Special care will be taken to prevent damage to lymphatic vessels in the Sham group, to allow a future LVA operation once the study ends. The follow-up moments will be at 3, 6, 12, 18, and 24 months. Additionally, a subset of patients will partake in an annual extended follow-up, ongoing until the start of the analysis. Each follow-up moment will last 45 minutes in total. The patient also receives two digital questionnaires at each follow-up moment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The researcher, research nurse and patients will be blinded. The blinded researcher and research nurse will perform the measurements during follow-up, as well as the assessment of the outcomes. Due to the nature of the study, the surgeon performing both procedures cannot be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treated for cancer and underwent treatment of either axillary or inguinal lymph nodes or radiotherapy;
- •Early stage lymphedema (ISL I-II) in the upper or lower extremity, and diagnosed by lymphoscintigraphy for the lower extremity;
- •Unilateral lymphedema;
- •Viable lymphatic vessels as determined by indocyanine green (ICG)Lymphography (stage II-III);
- •Refractory lymphedema that underwent at least three months of conservative treatment;
- •Informed consent.
排除标准
- •History of lymphatic reconstruction in the past 10 years;
- •Late-stage lymphedema of the extremity (ISL classification ≥ II lymphedema) with evident fat deposition and/or fibrosis;
- •Patients with active distant metastases, treated with palliative intent;
- •Patients with the active treatment of primary cancer, i.e. surgery, radiotherapy, and/or chemotherapy. Note: patients receiving adjuvant targeted and/or endocrine treatment are eligible;
- •Edema due to venous insufficiency, evaluated by venous duplex ultrasound of the deep and superficial venous system;
- •Active infection in the lymphedematous extremity;
- •Bilateral lymphedema;
- •Lymphedema present in genital or breast area only;
- •Primary lymphedema;
- •Non-viable lymphatic system as determined by ICG Lymphography (stages IV and V).
结局指标
主要结局
Change from Baseline in the Lymph-ICF Score at 12 and 24 months
时间窗: Baseline, 3, 6, 12, 18 and 24 months post-operatively and afterwards annualy during the extended follow-up, lasting up to the start of the first analysis (maximally 3 years extra or 3 additional visits).
The Dutch version of the 'Lymphedema Functioning, Disability, and Health" (Lymph-ICF) questionnaire is used. There are two versions of the Lymph-ICF; one for the upper extremity and one for the lower extremity. The questionnaires assess the impairments in function, activity limitations, and participation restrictions of patients with lymphedema. It is a validated, disease-specific questionnaire, consisting of items across 5 domains. Each item is scored on a VAS, ranging from 0 to 100.
Change from baseline in the Lymph-ICF Score at 12 and 24 months
时间窗: Baseline, 3, 6, 12, 18 and 24 months post-operatively and afterwards annually during the extended follow-up, lasting up to the start of the first analysis (maximally 3 years extra or 3 additional visits).
The Dutch version of the 'Lymphedema Functioning, Disability, and Health" (Lymph-ICF) questionnaire is used. There are two versions of the Lymph-ICF; one for the upper extremity and one for the lower extremity. The questionnaires assess the impairments in function, activity limitations, and participation restrictions of patients with lymphedema. It is a validated, disease-specific questionnaire, consisting of items across 5 domains. Each item is scored on a VAS, ranging from 0 to 100.
次要结局
- Change from baseline in excess limb volume(Baseline, 3, 6, 12, 18 and 24 months post-operatively and afterwards annualy during the extended follow-up, lasting up to the start of the first analysis (maximally 3 years extra or 3 additional visits).)
- Change from baseline in extremity circumference measured by the Upper and Lower Extremity Lymphedema (UEL and LEL) indices(Baseline, 3, 6, 12, 18 and 24 months post-operatively and afterwards annualy during the extended follow-up, lasting up to the start of the first analysis (maximally 3 years extra or 3 additional visits).)
- Change from baseline in the use of conservative treatment(Baseline, 3, 6, 12, 18 and 24 months post-operatively and afterwards annualy during the extended follow-up, lasting up to the start of the first analysis (maximally 3 years extra or 3 additional visits).)
- Postoperative complications(Baseline, 3, 6, 12, 18 and 24 months post-operatively and afterwards annualy during the extended follow-up, lasting up to the start of the first analysis (maximally 3 years extra or 3 additional visits).)
- Patency of the LVA(12 and 24 months post-operatively and afterwards annualy during the extended follow-up, lasting up to the start of the first analysis (maximally 3 years extra or 3 additional visits).)
- Patient costs, QALYs, and incremental cost-effectiveness(, lasting up to the start of the first analysis (maximally 3 years extra or 3 additional visits).)
- Change from baseline in excess limb volume(Baseline, 3, 6, 12, 18 and 24 months post-operatively and afterwards annually during the extended follow-up, lasting up to the start of the first analysis (maximally 3 years extra or 3 additional visits).)
- Change from baseline in extremity circumference measured by the Upper and Lower Extremity Lymphedema (UEL and LEL) indices(Baseline, 3, 6, 12, 18 and 24 months post-operatively and afterwards annually during the extended follow-up, lasting up to the start of the first analysis (maximally 3 years extra or 3 additional visits).)
- Change from baseline in the use of conservative treatment(Baseline, 3, 6, 12, 18 and 24 months post-operatively and afterwards annually during the extended follow-up, lasting up to the start of the first analysis (maximally 3 years extra or 3 additional visits).)
- Postoperative complications(Baseline, 3, 6, 12, 18 and 24 months post-operatively and afterwards annually during the extended follow-up, lasting up to the start of the first analysis (maximally 3 years extra or 3 additional visits).)
- Patency of the LVA(12 and 24 months post-operatively and afterwards annually during the extended follow-up, lasting up to the start of the first analysis (maximally 3 years extra or 3 additional visits).)
- Patient costs, QALYs, and incremental cost-effectiveness(Baseline, 3, 6, 12, 18 and 24 months post-operatively and afterwards annually during the extended follow-up, lasting up to the start of the first analysis (maximally 3 years extra or 3 additional visits).)