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

Primary Purpose

Esophageal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
intraoperative nerve monitoring
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophageal Cancer, Minimally invasive surgery, Recurrent laryngeal nerves, Intraoperative nerve monitoring

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Department of minimally invasive esophageal surgery, Tianjin Medical University Cancer Institute and HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Thoracoscopic esophagectomy without IONM

Thoracoscopic esophagectomy with IONM

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of nodes removed along the right and left RLN
number of lymph node removed
Value of IONM during operation
Post esophagectomy pneumonia rate
Operation time (thoracic phase)

Full Information

First Posted
January 5, 2022
Last Updated
May 30, 2022
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05199168
Brief Title
Visualization Versus Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerves During Thoracoscopic Esophagectomy
Official Title
Randomized Clinical Trial of Visualization Versus Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerves During Thoracoscopic Esophagectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
Esophageal Cancer, Minimally invasive surgery, Recurrent laryngeal nerves, Intraoperative nerve monitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thoracoscopic esophagectomy without IONM
Arm Type
No Intervention
Arm Title
Thoracoscopic esophagectomy with IONM
Arm Type
Experimental
Arm Description
Intraoperative bilateral recurrent laryngeal nerve monitoring was utilized during dissection of right and left recurrent laryngeal nerve lymph nodes.
Intervention Type
Procedure
Intervention Name(s)
intraoperative nerve monitoring
Intervention Description
Intraoperative bilateral recurrent laryngeal nerve monitoring was utilized during dissection of right and left recurrent laryngeal nerve lymph nodes.
Primary Outcome Measure Information:
Title
Incidence of the recurrent laryngeal nerve injury
Description
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.
Time Frame
Till 6 months postoperatively
Secondary Outcome Measure Information:
Title
Number of nodes removed along the right and left RLN
Description
number of lymph node removed
Time Frame
The pathological analysis will be finished within 2 weeks.
Title
Value of IONM during operation
Time Frame
1 Day of surgery
Title
Post esophagectomy pneumonia rate
Time Frame
Duration of hospital stay, an expected average of 2~3 weeks.
Title
Operation time (thoracic phase)
Time Frame
Intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Histologically proven primary intrathoracic middle and lower esophageal squamous cell carcinoma and will undergo McKeown MIE and bilateral RLN lymph ndoe dissection. No superclavicular lymph node metastasis after preoperative examination. No contraindication for esophagectomy. Expected surgical R0 resection. Exclusion Criteria: Pre-existed vocal cord dysfunction. Thorax pleural adhesion rendering minimal invasive approach unfeasible. Gastric tube cannot be used for reconstruction. Combined with hemorrhagic disease. Psychiatric patients. Inability to undergo curative resection and/or follow-up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongjing Jiang, MD. Ph.D.
Phone
02223340123
Email
jianghongjing@tmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zhao Ma, MD. Ph.D.
Phone
15620610559
Email
mazhao2015@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongjing Jiang, MD. Ph.D.
Organizational Affiliation
Tianjin Medical University Cancer Institute and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of minimally invasive esophageal surgery, Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongjing Jiang, MD,PhD
Phone
18622221069
Email
jianghongjing@tmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Zhao Ma, MD,PhD
Phone
15620610559
Email
mazhao2015@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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