Robotic-assisted Esophagectomy vs. Video-Assisted Thoracoscopic Esophagectomy(REVATE) Trial

NCT03713749 | Unknown

• 1 other identifier: 201800322A3C601
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will assess the adequacy of nodal dissection along the recurrent laryngeal nerve performed with robot-assisted versus video-assisted thoracoscopic esophagectomy in patients with esophageal squamous cell carcinoma through a prospective multicentre randomized study design.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Robotic esophagectomy; Video-assisted thoracoscopic esophagectomy; Recurrent laryngeal nerve lymh node; Esophageal squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Rate of unsuccessful LND along the left RLN

  Regardless of the presence of hoarseness, vocal cord function will be assessed by an experienced otolaryngologist using a nexile laryngoscope within one week of surgery. RLN palsy will be classified according to the following variables: site (unilateral versus bilateral); duration (temporary \[i.e., recovering within 6 months\] versus permanent \[i.e. not recovering within 6 months\]); and type of treatment required (type I: no therapy required; type II: injury requiring an elective surgical procedure; type III: injury requiring an urgent surgical procedure)

  Till 6 months postoperatively

Secondary Outcomes (20)

• The number of nodes removed along the right and left RLN

  The pathological analysis will be finished within 2 weeks.

• Post esophagectomy pneumonia rate

  Duration of hospital stay, an expected average of 2~3 weeks

• Rate of major postoperative complication

  Duration of hospital stay, an expected average of 2~3 weeks

• In hospital, 30 day and 90 day mortality

  Participants will be followed for the duration of hospital stay, an expected average of 2 weeks and within 30 days or 90 days

• R0 resection rate

  The pathological analysis will be finished within 2 weeks.

Study Arms (2)

Robot Esophagectomy (RE)

EXPERIMENTAL

Patients in the RE group will receive robotic-assisted esophagectomy with standard total two-field lymphadenectomy.

Device: Robot esophagectomy (RE)

Video-assisted thoracoscopic esophagectomy (VATE)

NO INTERVENTION

Patients in the VATE group will receive thoracoscopic esophagectomy with standard total two-field lymphadenectomy.

Interventions

Robot esophagectomy (RE) DEVICE

Patients in RE group will receive Robotic-assisted surgery in thoracic phase.

Robot Esophagectomy (RE)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18\~80
• Histologically proven primary intrathoracic esophageal squamous cell carcinoma and will undergo McKeown MIE and bilateral RLN LND.
• Patients should have a performance status 0, 1 or 2 according to the European Clinical Oncology Group.
• Surgical resectable(cT1\~4a, N0\~3, M0)
• Written informed consent

You may not qualify if:

• Previous major thoracic surgery rendering minimal invasive approach unfeasible
• prognosis determining malignancy other than esophageal cancer, inability to undergo curative resection and/or follow-up
• inability to provide oral or written informed consent.
• pre-existed vocal cord dysfunction will also be excluded.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Shanghai Chest Hospital: collaborator
• Tianjin Medical University Cancer Institute and Hospital: collaborator

Study Sites (1)

Chang Gung memorial hospital-Linkou

Taoyuan District, 333, Taiwan

RECRUITING

Related Publications (28)

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• 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 DERIVED

• Chao YK, Li ZG, Wen YW, Kim DJ, Park SY, Chang YL, van der Sluis PC, Ruurda JP, van Hillegersberg R. Robotic-assisted Esophagectomy vs Video-Assisted Thoracoscopic Esophagectomy (REVATE): study protocol for a randomized controlled trial. Trials. 2019 Jun 10;20(1):346. doi: 10.1186/s13063-019-3441-1.

  PMID: 31182150 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 22, 2018
• Study Start: October 22, 2018
• Primary Completion: April 22, 2022
• Study Completion: December 22, 2022
• Last Updated: July 1, 2021

Record last verified: 2021-03

Locations

TW (1)