Comparing bronchial blockers and double-lumen tubes in esophagectomy
Incidence of Postoperative Vocal Cord Palsy Between Double-lumen Endobronchial Tube and Bronchial Blocker for Robot-assisted Esophagectomy: a Multicenter Randomized Controlled Trial
This study is testing if using a bronchial blocker instead of a double-lumen tube during esophagus surgery can help prevent voice problems in adults who need lymph node removal near their vocal cords.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 202 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06897501 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether using a bronchial blocker instead of a double-lumen endobronchial tube can reduce the incidence of postoperative vocal cord palsy in patients undergoing robot-assisted esophagectomy. The study focuses on adults who require resection of recurrent laryngeal nerve lymph nodes during surgery, a procedure that poses risks of nerve injury. By comparing these two ventilation methods, the researchers aim to determine which approach better protects against vocal cord damage post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 or older with esophageal cancer who are scheduled for elective robot-assisted esophagectomy.
Not a fit: Patients with pre-existing vocal cord palsy or those requiring specific airway devices due to airway problems may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing esophagectomy.
How similar studies have performed: While few studies have directly compared these two devices, the approach of minimizing nerve injury during esophagectomy is supported by existing literature.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Hyun Joo Ahn, MD PhD — Samsung Medical Center
- Study coordinator: Hyun Joo Ahn, MD PhD
- Email: hyunjooahn@skku.edu
- Phone: +821099330784
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.