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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05199168
• Other study ID #: E20210023
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: January 2022
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Hongjing Jiang, MD. Ph.D.
• Phone: 02223340123
• Email: jianghongjing[@]tmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Department of minimally invasive esophageal surgery, Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

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