Clinical trial · Interventional
Visualization Versus Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerves During Thoracoscopic Esophagectomy
Randomized Clinical Trial of Visualization Versus Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerves During Thoracoscopic Esophagectomy
NCT05199168CI-TRIAL-00058828unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intraoperative nerve monitoring | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Thoracoscopic esophagectomy without IONM
- type
- EXPERIMENTAL
- label
- Thoracoscopic esophagectomy with IONM
- description
- Intraoperative bilateral recurrent laryngeal nerve monitoring was utilized during dissection of right and left recurrent laryngeal nerve lymph nodes.
- interventionNames
- Procedure: intraoperative nerve monitoring
Primary outcomes (1)
- measure
- Incidence of the recurrent laryngeal nerve injury
- timeFrame
- Till 6 months postoperatively
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.