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

Samsung Medical Center

Status: Enrolling

Conditions: One Lung Ventillation (OLV)

Treatments: Device: double-lumen endobronchial tube; Device: bronchial blocker

Study type: Interventional

Funder types: Other

Identifiers

NCT06897501

SMC 2024-12-120

Details and patient eligibility

About

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.

Full 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.

Enrollment: 202 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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202 participants in 2 patient groups

double-lumen endobronchial tube group

Active Comparator group

Treatment:

Device: double-lumen endobronchial tube

bronchial blocker group

Experimental group

Treatment:

Device: bronchial blocker