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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05199168
Other study ID # E20210023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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