An interventional study of bronchial blocker and double-lumen endobronchial tube in One Lung Ventillation (OLV), sponsored by Samsung Medical Center. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-05-18.
Sponsored by Samsung Medical Center · Not applicable, Interventional, and Prevention
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.
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.
55 studies on the registry are indexed under Vocal Cord Paralysis; 14 are open to participants now.
This study's planned enrollment of 202 is above the median of 39 across 38 interventional studies indexed under Vocal Cord Paralysis.
Browse Vocal Cord Paralysis studies →Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: double-lumen endobronchial tube
Device: bronchial blocker
Lung isolation for robot-assisted esophagectomy will be performed using bronchial blocker in this group.
Lung isolation for robot-assisted esophagectomy will be performed using double-lumen endobronchial tube in this group.
Postoperative vocal cord palsy
On postoperative day 7, ENT doctor will performed the laryngoscopy exam to check the presence of vocal cord palsy.
Time frame: On postoperative day 7 after robot-assisted esophagectomy
Number of resected recurrent laryngeal nerve lymph nodes
Number of successfully resected recurrent laryngeal nerve lymph nodes will be counted at the end of surgery
Time frame: At the end of surgery
Quality of one lung ventilation
during one lung ventilation, anesthesiologists will evaluate the degree (excellent, fair, poor) of lung collapse.
Time frame: during one lung ventilation
Surgical difficulty reported by surgeon
Surgeon will report the surgical difficulty (easy, moderate, difficult).
Time frame: At the end of surgery
Plan to share: Undecided
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