NCT05199168

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
PROCEDURE	intraoperative nerve monitoring	Intraoperative bilateral recurrent laryngeal nerve monitoring was utilized during dissection of right and left recurrent laryngeal nerve lymph nodes.

Timeline

• Start date: 2022-03-01
• Primary completion: 2024-02-01
• Completion: 2024-07-01
• First posted: 2022-01-20
• Last updated: 2022-06-01

Locations

1 site across 1 country: China