Postoperative Vocal Cord Palsy Between Double-lumen Endobronchial Tube and Bronchial Blocker for Robot-assisted Esophagectomy
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: bronchial blocker, double-lumen endobronchial tube.
- Who it may be relevant to
- Registry conditions: One Lung Ventillation (OLV). Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Incidence of Postoperative Vocal Cord Palsy Between Double-lumen Endobronchial Tube and Bronchial Blocker for Robot-assisted Esophagectomy: a Multicenter Randomized Controlled Trial
Overview
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.
Interventions
- Device bronchial blocker
Lung isolation for robot-assisted esophagectomy will be performed using bronchial blocker in this group. - Device double-lumen endobronchial tube
Lung isolation for robot-assisted esophagectomy will be performed using double-lumen endobronchial tube in this group.
Primary outcome measures
- Postoperative vocal cord palsy [Time frame: On postoperative day 7 after robot-assisted esophagectomy]
Secondary outcome measures (3)
- Number of resected recurrent laryngeal nerve lymph nodes [Time frame: At the end of surgery]
- Quality of one lung ventilation [Time frame: during one lung ventilation]
- Surgical difficulty reported by surgeon [Time frame: At the end of surgery]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
South Korea · 1 center
- Samsung Medical Center — Seoul
Publications
- Chao YK, Li Z, Jiang H, Wen YW, Chiu CH, Li B, Shang X, Fang TJ, Yang Y, Yue J, Zhang X, Zhang C, Liu YH. Multicentre randomized clinical trial on robot-assisted versus video-assisted thoracoscopic oesophagectomy (REVATE trial). Br J Surg. 2024 Jul 2;111(7):znae143. doi: 10.1093/bjs/znae143. PMID 38960881
- Li B, Yang Y, Toker A, Yu B, Kang CH, Abbas G, Soukiasian HJ, Li H, Daiko H, Jiang H, Fu J, Yi J, Kernstine K, Migliore M, Bouvet M, Ricciardi S, Chao YK, Kim YH, Wang Y, Yu Z, Abbas AE, Sarkaria IS, Li Z; Cooperative Group of International Expert Consensus on Robot-assisted Esophagectomy for Esophageal Cancer. International consensus statement on robot-assisted minimally invasive esophagectomy (R PMID 33447428
- Palaczynski P, Misiolek H, Szarpak L, Smereka J, Pruc M, Rydel M, Czyzewski D, Bialka S. Systematic Review and Meta-Analysis of Efficiency and Safety of Double-Lumen Tube and Bronchial Blocker for One-Lung Ventilation. J Clin Med. 2023 Feb 27;12(5):1877. doi: 10.3390/jcm12051877. PMID 36902663
Identifiers
NCT: NCT06897501 · SMC 2024-12-120