Feasibility and Safety of Minimally Invasive Inguinal Lymph Node Dissection in Patients With Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 88
- 试验地点
- 11
- 主要终点
- Proficiency score per surgery
研究概览
简要总结
The purpose of this this study is to determine if a structured educational training program is successful in teaching surgeons a new operative technique. It will then be determined if this new operative technique is safe.
详细描述
This study is a multi-center, Phase 1 clinical trial to determine the safety and feasibility of minimally invasive inguinal lymph node dissection for patients with melanoma. Licensed surgeons who have undergone special training, including a course at the Mayo Clinic Rochester in minimally invasive lymph node dissection (MILND) will perform the new procedure at their home institutions. The study will characterize the learning curve of MILND in the clinical setting, and evaluate the safety of the new operative technique.
The hypotheses for this study are: 1) minimally invasive groin dissection is a safe procedure. 2) a structured educational training program is a feasible and effective method to train practicing surgeons in this novel procedure and 3) pre-course generic laparoscopic technical skills correlate with minimally invasive superficial groin dissection performance in a clinical setting, including operative oncologic standards and safety metrics.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Malignant melanoma present in an inguinal nodal basin requiring superficial inguinal lymph node dissection.
- •Plan for superficial inguinal dissection alone or combined superficial inguinal and deep pelvic node dissection is acceptable.
- •Clinical or radiographic evidence of superficial inguinal lymph node disease or a prior positive single lymph node biopsy of the superficial inguinal basin as an indication for superficial inguinal lymph node disease is acceptable.
- •Patients must be Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 and be healthy enough to undergo a general anesthetic (no epidural or spinal anesthetics).
- •Female patients of child bearing age must have a negative pregnancy test, be surgically sterile or post-menopausal greater than 1 year.
- •Patients must be able to return to surgical facility for 30 and/or 90 day (+/- 20 days) for follow-up appointment.
排除标准
- •Prior ipsilateral superficial inguinal lymph node dissection
- •Invasion or ulceration of inguinal nodal disease into the overlying skin
- •Prior radiation therapy to the same regional nodal basin.
研究组 & 干预措施
Minimally invasive surgery
Minimally invasive inguinal lymph node dissection is a 10-step technique to provide novel inguinal lymph node staging and treatment.
干预措施: Minimally invasive inguinal lymph node dissection (Procedure)
结局指标
主要结局
Proficiency score per surgery
时间窗: Approximately 90 days following surgical procedure
The proficiency score is a function of the lymph nodes pathologically identified, the amount of blood transfused and the operative time. The range is 0 to 3, with higher proficiency in performing the procedure being 3.
次要结局
- Morbidity and percentage of patients converted to open surgical procedure(Approximately 90 days following surgical procedure)
研究者
James W. Jakub
Breast and Melanoma Surgery Section Head
Mayo Clinic