One Lung Ventillation (OLV)NCT06897501
Postoperative Vocal Cord Palsy Between Double-lumen Endobronchial Tube and Bronchial Blocker for Robot-assisted Esophagectomy
A study testing bronchial blocker and double-lumen endobronchial tube in people with One Lung Ventillation (OLV), run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- One Lung Ventillation (OLV)
- What is being tested?
- bronchial blocker and double-lumen endobronchial tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Apr 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Heejoon Jeong, MD, +82-2-3410-0841, heejoonjeong@skku.edu
Hyun Joo Ahn, MD, PhD
About this study
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
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.
Read the 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.
- Conditions
- One Lung Ventillation (OLV)
- Being tested
- bronchial blocker, double-lumen endobronchial tube
- Keywords
- robot-assisted esophagectomy, double-lumen endobronchial tube, bronchial blocker, vocal cord palsy
- Medical subject headings
- Vocal Cord Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchial blockerDevice
Lung isolation for robot-assisted esophagectomy will be performed using bronchial blocker in this group.
double-lumen endobronchial tubeDevice
Lung isolation for robot-assisted esophagectomy will be performed using double-lumen endobronchial tube in this group.
| Study group | Role | What they receive |
|---|---|---|
| double-lumen endobronchial tube group | Active comparator | Not described Receives: Device: double-lumen endobronchial tube |
| bronchial blocker group | Experimental | Not described Receives: Device: bronchial blocker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative vocal cord palsy
On postoperative day 7, ENT doctor will performed the laryngoscopy exam to check the presence of vocal cord palsy.
Measured: On postoperative day 7 after robot-assisted esophagectomy
Secondary outcomes (3)
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
Measured: 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.
Measured: during one lung ventilation
Surgical difficulty reported by surgeon
Surgeon will report the surgical difficulty (easy, moderate, difficult).
Measured: At the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start14 Apr 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for One Lung Ventillation (OLV)Studies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun Joo Ahn, Samsung Medical Center
- Investigators
- Hyun Joo Ahn, MD PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897501
- Sponsor's protocol ID
- SMC 2024-12-120
- Status last verified
- May 2025
- First submitted
- 25 Mar 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 38960881Li 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.
PubMed 33447428Palaczynski 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.
PubMed 36902663
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06897501
- Acronym / sponsor ID
- SMC 2024-12-120
- Conditions
- One Lung Ventillation (OLV)
- Keywords
- robot-assisted esophagectomy, double-lumen endobronchial tube, bronchial blocker, vocal cord palsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| double-lumen endobronchial tube group | Active comparator | Device: double-lumen endobronchial tube |
| bronchial blocker group | Experimental | Device: bronchial blocker |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bronchial blockerLung isolation for robot-assisted esophagectomy will be performed using bronchial blocker in this group. | Device | bronchial blocker group |
| double-lumen endobronchial tubeLung isolation for robot-assisted esophagectomy will be performed using double-lumen endobronchial tube in this group. | Device | double-lumen endobronchial tube group |
Primary outcome
Postoperative vocal cord palsy
Time frame: On postoperative day 7 after robot-assisted esophagectomy
On postoperative day 7, ENT doctor will performed the laryngoscopy exam to check the presence of vocal cord palsy.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Results publication: PubMed 38960881Chao 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.
- Results publication: PubMed 33447428Li 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.
- Results publication: PubMed 36902663Palaczynski 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hyun Joo Ahn, MD PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bronchial blocker and double-lumen endobronchial tube in people with One Lung Ventillation (OLV), run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hyun Joo Ahn, MD PhD (+821099330784, hyunjooahn@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative vocal cord palsy (time frame: On postoperative day 7 after robot-assisted esophagectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06897501, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.