Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06897501

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

Location status: Recruiting

Location contact

Heejoon Jeong, MD

CONTACT

[email protected]

+82-2-3410-0841

Hyun Joo Ahn, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bronchial blocker

Device

Lung isolation for robot-assisted esophagectomy will be performed using bronchial blocker in this group.

double-lumen endobronchial tube

Device

Lung isolation for robot-assisted esophagectomy will be performed using double-lumen endobronchial tube in this group.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. Surgical difficulty reported by surgeon

    Time frame: At the end of surgery

    Surgeon will report the surgical difficulty (easy, moderate, difficult).

Study contacts

Contact information is provided by the study sponsor or research team.

Heejoon Jeong, MD

CONTACT

[email protected]

+821087282414

Hyun Joo Ahn, MD PhD

CONTACT

[email protected]

+821099330784

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2025
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.