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临床试验/NCT04246034
NCT04246034撤回不适用

Evaluation of Outcomes of Microvascular Breast Reconstruction With Lymph Node Transfer for Postmastectomy Lymphedema Patients

Assiut University0 个研究点开始时间: 2021年1月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Change in upper limb volume

研究概览

简要总结

this study aims to evaluate the outcomes of simultaneous free abdominal flap & vascularized lymph node transfer for both breast reconstruction and postmastectomy lymphedema

详细描述

Microvascular breast reconstruction allows for the transfer of donor tissue that is an excellent match for native breast tissue, both in terms of the subcutaneous tissue that reconstitutes the breast mound and the simultaneous transfer of skin. In addition, it offers a wide range of options for women who may have been previously not considered for autologous tissue transfer. From the these various options, the deep inferior epigastric artery perforator (DIEP) flap and the muscle-sparing transverse rectus abdominis myocutaneous (MS-TRAM) flap are the most recognized free flap options for breast reconstruction today

Besides the needs for breast reconstruction after mastectomy & axillary lymph node dissection, upper limb lymphedema is also a major concern for postmastectomy patients which is estimated to occur in 21.4% of women treated for breast cancer. It represents a diagnostic and therapeutic challenge for clinicians due to the heterogeneity in presentation as well as multitude of treatment options available. In addition, with a lack of evidence-based guidelines

. According to the International Society of Lymphology Consensus, the clinical staging of lymphedema includes; Stage 0 (Subclinical) when lymphatic vessels have been injured but have no measurable swelling or edema. Stage I lymphedema occurs with the onset of measurable swelling and pitting of the skin which can be regressed on conservative treatments. Stage II considered when there is edema partially regressing with treatments and negative pitting test. Stage III encompasses lymphostatic elephantiasis with trophic skin changes and recurrent infections.

In recent years, lymphatic microsurgery procedures have increased in popularity, bringing in a new wave of physiologic surgical options for the management of lymphedema. The two most common microsurgical options include lymphovenous anastomosis (LVA) and vascularized lymph node transfer (VLNT). Each treatment option has the potential to bypass areas of damaged lymphatics by rerouting the lymph into the venous system or by replacing the lost lymph nodes and, or lymphatic ducts.

Recent studies have evaluated the positive effects of VLNT in the setting of lymphedema and have shown significantly better results for the patients in which the native lymphatic ducts are no longer available when compared to conservative treatments or LVA.

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
20 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients of 20-65 years old
  • Patients seeking autologous breast reconstruction and complain of clinically diagnosed arm lymphedema
  • Deficient lymphatic drainage on lymphoscintigraphy
  • Stage II and III Lymphedema
  • no active cellulitis
  • more than 12 months of follow-up

排除标准

  • Females < 20 or >65 years old
  • distant metastasis
  • brachial plexus neuritis.
  • Patients with unhealthy and obstructed recipient veins or congestive heart disease with limited venous return may not be a suitable candidate for the procedure.

结局指标

主要结局

Change in upper limb volume

时间窗: 6-12 months

Assessment of volume reduction by measuring limb circumference of affected and non affected upper limbs at fixed points from shoulder, elbow \& wrist joints

Change in lymphatic flow

时间窗: 6-12 months

lymphoscintigraphy will be used to trace radiological signs of Lymphatic flow improvement such as reduced dermal backflow, appearance of new lymph drainage channels, reduced stasis and increased rate of radiolabeled tracer clearance

次要结局

  • Quality of life measure for breast(6-12 months)
  • Quality of life measure for limb lymphedema (LYMQOL)(6-12 months)

研究者

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

Ahmed ElSayed Sharaf Ahmed

Assistant Lecturer

Assiut University

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