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

Not Applicable

Recruiting

• Conditions: One Lung Ventillation (OLV)

• Registration Number: NCT06897501
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

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 Timeline

• Study First Submitted: 2025-03-25
• Study First Submitted QC: 2025-03-25
• Study First Posted: 2025-03-27
• Study Start: 2025-04-14
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 202

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative vocal cord palsy	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 Outcome Measures

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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of