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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thoracoscopic esophagectomy without IONM | No Intervention | ||
| Thoracoscopic esophagectomy with IONM | Experimental | Intraoperative bilateral recurrent laryngeal nerve monitoring was utilized during dissection of right and left recurrent laryngeal nerve lymph nodes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intraoperative nerve monitoring | Procedure | Intraoperative bilateral recurrent laryngeal nerve monitoring was utilized during dissection of right and left recurrent laryngeal nerve lymph nodes. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongjing Jiang, MD. Ph.D. | Contact | 02223340123 | jianghongjing@tmu.edu.cn | |
| Zhao Ma, MD. Ph.D. | Contact | 15620610559 | mazhao2015@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongjing Jiang, MD. Ph.D. | Tianjin Medical University Cancer Institute and Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of minimally invasive esophageal surgery, Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D064795 | Intraoperative Neurophysiological Monitoring |
| ID | Term |
|---|---|
| D016343 | Monitoring, Intraoperative |
| D008991 | Monitoring, Physiologic |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Post esophagectomy pneumonia rate | Duration of hospital stay, an expected average of 2~3 weeks. |
| Operation time (thoracic phase) | Intraoperative |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D064926 | Neurophysiological Monitoring |
| D013514 | Surgical Procedures, Operative |