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临床试验/NCT05441943
NCT05441943进行中(未招募)不适用

Lymphaticovenous Anastomosis as a Surgical Treatment for Breast Cancer-Related Lymphedema

Odense University Hospital2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年5月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
10
试验地点
2
主要终点
Number of vessels planned for surgery surgery

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Iatrogenic lymphedema following treatment for breast cancer in upper extremity
  • Possible to obtain informed consent

排除标准

  • Duration of disease over 24 months
  • Untreated or uncontrolled primary cancer
  • No applicable lymphatic vessels identified, using ICG lymphangiography
  • No applicable venous vessels identified using ultra high frequency ultrasound

研究组 & 干预措施

Lymphovenous anastomosis surgery

Experimental

Lymphovenous anastomosis surgery with pre-operative planning using ICG lymphography and ultra high frequency ultrasound.

干预措施: Lymphovenous anastomosis (Procedure)

结局指标

主要结局

Number of vessels planned for surgery surgery

时间窗: Preoperative

The number of mapped lymphatics vessels and venoles.

Number of vessels found during surgery

时间窗: Perioprative

The number of vessels found during surgery. This number will be compared to the number of vessels planned for surgery.

次要结局

  • Changes of fat mass (kg) relative to weight (kg), measured in percentage.(Baseline and 3 months follow-up)
  • Changes in L-Dex score(Baseline and 3 months follow-up)
  • Changes of arm volume(Baseline and 3 months follow-up)
  • Change of extracellular fluid (liters) relative to total body water (liters), measured in percentage.(Baseline and 3 months follow-up)
  • Changes of intracellular fluid (liters) relative to total body water (liters), measured in percentage.(Baseline and 3 months follow-up)
  • Changes of total body water (liters) relative to weight (kg), measured in percentage.(Baseline and 3 months follow-up)
  • Changes of proteins and minerals (kg) relative to weight (kg), measured in percentage.(Baseline and 3 months follow-up)
  • Changes in health-related quality-of-life measured by the LYMPH-Q questionnaire(Baseline and 3 months follow-up)
  • Changes in active tissue mass (kg) relative to weight (kg), measured in percentage.(Baseline and 3 months follow-up)
  • Changes of skeletal muscle mass (kg) relative to weight (kg), measured in percentage.(Baseline and 3 months follow-up)
  • Changes of lymphatic flow pattern before and after surgery by ICG lymphangiography(Baseline and 3 months follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Caroline Lilja

Principal Investigator

Odense University Hospital

研究点 (2)

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