NCT05199168

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

June 1, 2022

Status Verified

January 1, 2022

Enrollment Period

1.9 years

First QC Date

January 5, 2022

Last Update Submit

May 30, 2022

Conditions

Esophageal Cancer

Keywords

Esophageal CancerMinimally invasive surgeryRecurrent laryngeal nervesIntraoperative nerve monitoring

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Number of nodes removed along the right and left RLN

    The pathological analysis will be finished within 2 weeks.

  • Value of IONM during operation

    1 Day of surgery

  • Post esophagectomy pneumonia rate

    Duration of hospital stay, an expected average of 2~3 weeks.

  • Operation time (thoracic phase)

    Intraoperative

Study Arms (2)

Thoracoscopic esophagectomy without IONM

NO INTERVENTION

Thoracoscopic esophagectomy with IONM

EXPERIMENTAL

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

Procedure: intraoperative nerve monitoring

Interventions

intraoperative nerve monitoringPROCEDURE

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

Thoracoscopic esophagectomy with IONM

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Intraoperative Neurophysiological Monitoring

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Monitoring, IntraoperativeMonitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosisNeurophysiological MonitoringSurgical Procedures, Operative

Study Officials

  • Hongjing Jiang, MD. Ph.D.

    Tianjin Medical University Cancer Institute and Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongjing Jiang, MD. Ph.D.

CONTACT

02223340123jianghongjing@tmu.edu.cn

Zhao Ma, MD. Ph.D.

CONTACT

15620610559mazhao2015@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2022

First Posted

January 20, 2022

Study Start

March 1, 2022

Primary Completion

February 1, 2024

Study Completion

July 1, 2024

Last Updated

June 1, 2022

Record last verified: 2022-01

Locations

CN(1)