Clinical trial NCT05199168: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Cancer
Keywords: Esophageal Cancer
Minimally invasive surgery
Recurrent laryngeal nerves
Intraoperative nerve monitoring
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of the recurrent laryngeal nerve injury
timeFrame: Till 6 months postoperatively
Secondary outcomes:
measure: Number of nodes removed along the right and left RLN
timeFrame: The pathological analysis will be finished within 2 weeks.
measure: Value of IONM during operation
timeFrame: 1 Day of surgery
measure: Post esophagectomy pneumonia rate
timeFrame: Duration of hospital stay, an expected average of 2~3 weeks.
measure: Operation time (thoracic phase)
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Department of minimally invasive esophageal surgery, Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Hongjing Jiang, MD. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: