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

Tianjin Medical University

Status: Enrolling

Conditions: Esophageal Cancer

Treatments: Procedure: intraoperative nerve monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT05199168

E20210023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Histologically proven primary intrathoracic middle and lower esophageal squamous cell carcinoma and will undergo McKeown MIE and bilateral RLN lymph ndoe dissection.
2. No superclavicular lymph node metastasis after preoperative examination.
3. No contraindication for esophagectomy.
4. Expected surgical R0 resection.

Exclusion criteria

1. Pre-existed vocal cord dysfunction.
2. Thorax pleural adhesion rendering minimal invasive approach unfeasible.
3. Gastric tube cannot be used for reconstruction.
4. Combined with hemorrhagic disease.
5. Psychiatric patients.
6. Inability to undergo curative resection and/or follow-up.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Thoracoscopic esophagectomy without IONM

No Intervention group

Thoracoscopic esophagectomy with IONM

Experimental group

Description:

Intraoperative bilateral recurrent laryngeal nerve monitoring was utilized during dissection of right and left recurrent laryngeal nerve lymph nodes.

Treatment:

Procedure: intraoperative nerve monitoring