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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| double-lumen endobronchial tube group | Active Comparator |
| |
| bronchial blocker group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bronchial blocker | Device | Lung isolation for robot-assisted esophagectomy will be performed using bronchial blocker in this group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative vocal cord palsy | On postoperative day 7, ENT doctor will performed the laryngoscopy exam to check the presence of vocal cord palsy. | On postoperative day 7 after robot-assisted esophagectomy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At the end of surgery |
| Quality of one lung ventilation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyun Joo Ahn, MD PhD | Contact | +821099330784 | hyunjooahn@skku.edu | |
| Heejoon Jeong, MD | Contact | +821087282414 | heejoonjeong@skku.edu |
| Name | Affiliation | Role |
|---|---|---|
| Hyun Joo Ahn, MD PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38960881 | Result | 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. | |
| 33447428 | Result |
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| double-lumen endobronchial tube | Device | Lung isolation for robot-assisted esophagectomy will be performed using double-lumen endobronchial tube in this group. |
|
during one lung ventilation, anesthesiologists will evaluate the degree (excellent, fair, poor) of lung collapse.
| during one lung ventilation |
| Surgical difficulty reported by surgeon | Surgeon will report the surgical difficulty (easy, moderate, difficult). | At the end of surgery |
| 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. |
| 36902663 | Result | 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. |
| ID | Term |
|---|---|
| D014826 | Vocal Cord Paralysis |
| ID | Term |
|---|---|
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D020421 | Vagus Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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