Clinical trial NCT06897501: Postoperative Vocal Cord Palsy Between Double-lumen Endobronchial Tube and Bronchial Blocker for Robot-assisted Esophagectomy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: One Lung Ventillation (OLV)
Keywords: robot-assisted esophagectomy
double-lumen endobronchial tube
bronchial blocker
vocal cord palsy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2025-03-27
Enrollment: 202
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Postoperative vocal cord palsy
timeFrame: On postoperative day 7 after robot-assisted esophagectomy
Secondary outcomes:
measure: Number of resected recurrent laryngeal nerve lymph nodes
timeFrame: At the end of surgery
measure: Quality of one lung ventilation
timeFrame: during one lung ventilation
measure: Surgical difficulty reported by surgeon
timeFrame: At the end of surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center, Sungkyunkwan University School of Medicine
name: Hyun Joo Ahn, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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 (RAMIE). J Thorac Dis. 2020 Dec;12(12):7387-7401. doi: 10.21037/jtd-20-1945. No abstract available.
citation: 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.