Visualization Versus Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerves During Thoracoscopic Esophagectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Clinical Trial of Visualization Versus Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerves During Thoracoscopic Esophagectomy

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Procedure: intraoperative nerve monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Thoracoscopic esophagectomy without IONM<br> | |
| Experimental: Thoracoscopic esophagectomy with IONM<br>Intraoperative bilateral recurrent laryngeal nerve monitoring was utilized during dissection of right and left recurrent laryngeal nerve lymph nodes. | Procedure: intraoperative nerve monitoring<br>* Intraoperative bilateral recurrent laryngeal nerve monitoring was utilized during dissection of right and left recurrent laryngeal nerve lymph nodes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of the recurrent laryngeal nerve injury | 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. | Till 6 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of nodes removed along the right and left RLN | number of lymph node removed | The pathological analysis will be finished within 2 weeks. | 
| Value of IONM during operation |  | 1 Day of surgery | 
| Post esophagectomy pneumonia rate |  | Duration of hospital stay, an expected average of 2 3 weeks. | 
| Operation time (thoracic phase) |  | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal Cancer, Minimally invasive surgery, Recurrent laryngeal nerves, Intraoperative nerve monitoring