Randomized Clinical Trial of Visualization Versus Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerves During Thoracoscopic Esophagectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of the recurrent laryngeal nerve injury
研究概览
简要总结
The clinical value of intraoperative nerve monitoring (IONM) in thoracoscopic esophagectomy remains uncertain. The aim of this randomized clinical trial was to compare the impact of RLN visualization versus IONM on their morbidity following thoracoscopic esophagectomy.
详细描述
Recurrent laryngeal nerves (RLN) lymph nodes are the most common metastatic areas in esophageal squamous carcinoma. It is a clinical challenge to reduce high incidence of RLN injury rate result from routine dissection of RLN lymph nodes. Thoracoscopic approach may provide a clear operative field and potentially less invasive surgery. But there are still high RLN injury rate only depending on visualization of thoracoscopy. The use of intraoperative nerve monitoring (IONM) was shown very helpful to identify the RLN and associated with a reduction of RLN injury rate in thyroidectomy. However, there is no solid clinical evidence about the effectiveness of utility of IONM in thoracoscopic esophagectomy. Thus, the aim of this randomized clinical trial was to compare the impact of RLN visualization versus IONM on their morbidity following thoracoscopic esophagectomy.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Histologically proven primary intrathoracic middle and lower esophageal squamous cell carcinoma and will undergo McKeown MIE and bilateral RLN lymph ndoe dissection.
- •No superclavicular lymph node metastasis after preoperative examination.
- •No contraindication for esophagectomy.
- •Expected surgical R0 resection.
排除标准
- •Pre-existed vocal cord dysfunction.
- •Thorax pleural adhesion rendering minimal invasive approach unfeasible.
- •Gastric tube cannot be used for reconstruction.
- •Combined with hemorrhagic disease.
- •Psychiatric patients.
- •Inability to undergo curative resection and/or follow-up.
结局指标
主要结局
Incidence of the recurrent laryngeal nerve injury
时间窗: Till 6 months postoperatively
The vocal cord function will be assessed by an experienced otolaryngologist using a laryngoscope on 1st postoperative day.RLN palsy will be classified according to the following variables: site (unilateral versus bilateral); duration (temporary \[i.e., recovering within 6 months\] versus permanent \[i.e. not recovering within 6 months\])postoperatively.
次要结局
- Number of nodes removed along the right and left RLN(The pathological analysis will be finished within 2 weeks.)
- Post esophagectomy pneumonia rate(Duration of hospital stay, an expected average of 2~3 weeks.)
- Value of IONM during operation(1 Day of surgery)
- Operation time (thoracic phase)(Intraoperative)