NCT06897501

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Apr 2025Dec 2026

First Submitted

Initial submission to the registry

March 25, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

April 14, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 18, 2025

Status Verified

May 1, 2025

Enrollment Period

1.6 years

First QC Date

March 25, 2025

Last Update Submit

May 14, 2025

Conditions

One Lung Ventillation (OLV)

Keywords

robot-assisted esophagectomydouble-lumen endobronchial tubebronchial blockervocal cord palsy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Number of resected recurrent laryngeal nerve lymph nodes

    At the end of surgery

  • Quality of one lung ventilation

    during one lung ventilation

  • Surgical difficulty reported by surgeon

    At the end of surgery

Study Arms (2)

double-lumen endobronchial tube group

ACTIVE COMPARATOR
Device: double-lumen endobronchial tube

bronchial blocker group

EXPERIMENTAL
Device: bronchial blocker

Interventions

bronchial blockerDEVICE

Lung isolation for robot-assisted esophagectomy will be performed using bronchial blocker in this group.

bronchial blocker group
double-lumen endobronchial tubeDEVICE

Lung isolation for robot-assisted esophagectomy will be performed using double-lumen endobronchial tube in this group.

double-lumen endobronchial tube group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Related Publications (3)

  • 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: 38960881BACKGROUND

  • 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.

    PMID: 33447428BACKGROUND

  • 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: 36902663BACKGROUND

MeSH Terms

Conditions

Vocal Cord Paralysis

Condition Hierarchy (Ancestors)

Laryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesVagus Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hyun Joo Ahn, MD PhD

    Samsung Medical Center, Sungkyunkwan University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun Joo Ahn, MD PhD

CONTACT

+821099330784hyunjooahn@skku.edu

Heejoon Jeong, MD

CONTACT

+821087282414heejoonjeong@skku.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Anesthesiologist

Study Record Dates

First Submitted

March 25, 2025

First Posted

March 27, 2025

Study Start

April 14, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 18, 2025

Record last verified: 2025-05

Locations

KR(1)