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

Not Applicable

• Conditions: Esophageal Cancer
• Interventions: Procedure: intraoperative nerve monitoring

• Registration Number: NCT05199168
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief 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.

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-01-14
• Study First Posted: 2022-01-20
• Study Start: 2022-03-01
• Last Update Submitted: 2022-05-30
• Last Update Posted: 2022-06-01
• Primary Completion: 2024-02-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thoracoscopic esophagectomy with IONM	intraoperative nerve monitoring	Intraoperative bilateral recurrent laryngeal nerve monitoring was utilized during dissection of right and left recurrent laryngeal nerve lymph nodes.

Primary Outcome Measures

Name	Time	Method
Incidence of the recurrent laryngeal nerve injury	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.

Secondary Outcome Measures

Name	Time	Method
Number of nodes removed along the right and left RLN	The pathological analysis will be finished within 2 weeks.	number of lymph node removed
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

Trial Locations

Locations (1)

Department of minimally invasive esophageal surgery, Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China