Postoperative Vocal Cord Palsy Between Double-lumen Endobronchial Tube and Bronchial Blocker for Robot-assisted Esophagectomy

May 14, 2025 updated by: Hyun Joo Ahn, Samsung Medical Center

Incidence of Postoperative Vocal Cord Palsy Between Double-lumen Endobronchial Tube and Bronchial Blocker for Robot-assisted Esophagectomy: a Multicenter Randomized Controlled Trial

The goal of this clinical trial is to investigate whether the use of bronchial blocker could reduce the incidence of postoperative vocal cord palsy than the use of double-lumen endobronchial tube in robot-assisted esophagectomy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Esophagectomy is a challenging surgery that usually requires one lung ventilation, and double-lumen endobronchial tubes and bronchial blockers are commonly used for one lung ventilation.

Successful resection of recurrent laryngeal nerve lymph nodes during esophagectomy is important to survival and prevention of cancer recurrence, but there is a risk of postoperative vocal cord palsy due to the recurrent laryngeal nerve injury during the resection.

Compared to a double-lumen endobronchial tube, the use of a bronchial blocker is expected to reduce the incidence of recurrent laryngeal nerve injury; however, few clinical studies compare the two devices in terms of the incidence of postoperative vocal cord palsy in robot-assisted esophagectomy.

Therefore, the researchers aimed to investigate whether the use of bronchial blocker could reduce the incidence of postoperative vocal cord palsy than the use of double-lumen endobronchial tube in robot-assisted esophagectomy.

Study Type

Interventional

Enrollment (Estimated)

202

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
        • Contact:
        • Principal Investigator:
          • Hyun Joo Ahn, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 19 or older
  • American Society of Anesthesiologists physical status I - III
  • Elective robot-assisted esophagectomy
  • Any clinical stage of esophageal cancer
  • Patients who need recurrent laryngeal nerve lymph nodes resection

Exclusion Criteria:

  • Patients who diagnosed vocal cord palsy or damage before surgery
  • Patients who need specific airway device due to airway problem
  • History of thoracic surgery
  • Emergency surgery
  • Combined surgery with other department
  • Pregnant or nursing women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: double-lumen endobronchial tube group
Device: double-lumen endobronchial tube
Lung isolation for robot-assisted esophagectomy will be performed using double-lumen endobronchial tube in this group.
Experimental: bronchial blocker group
Device: bronchial blocker
Lung isolation for robot-assisted esophagectomy will be performed using bronchial blocker in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative vocal cord palsy
Time Frame: On postoperative day 7 after robot-assisted esophagectomy
On postoperative day 7, ENT doctor will performed the laryngoscopy exam to check the presence of vocal cord palsy.
On postoperative day 7 after robot-assisted esophagectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of resected recurrent laryngeal nerve lymph nodes
Time Frame: At the end of surgery
Number of successfully resected recurrent laryngeal nerve lymph nodes will be counted at the end of surgery
At the end of surgery
Quality of one lung ventilation
Time Frame: during one lung ventilation
during one lung ventilation, anesthesiologists will evaluate the degree (excellent, fair, poor) of lung collapse.
during one lung ventilation
Surgical difficulty reported by surgeon
Time Frame: At the end of surgery
Surgeon will report the surgical difficulty (easy, moderate, difficult).
At the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Hyun Joo Ahn, MD PhD, Samsung Medical Center, Sungkyunkwan University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

March 27, 2025

Study Record Updates

Last Update Posted (Actual)

May 18, 2025

Last Update Submitted That Met QC Criteria

May 14, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC 2024-12-120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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