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

NCT ID: NCT03713749

Last Updated: 2021-07-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-22
• Study Completion Date: 2022-12-22

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.

Detailed Description

Radical lymph node dissection (LND) along the recurrent laryngeal nerve (RLN) is surgically demanding and can be associated with substantial postoperative morbidity. The question as to whether robot-assisted esophagectomy (RE) might be superior to video-assisted thoracoscopic esophagectomy (VATE) for performing LND along the RLN in patients with esophageal squamous cell carcinoma (ESCC) remains open.

The investigators will conduct a multicenter, open-label, randomized controlled trial (termed REVATE) enrolling patients with ESCC scheduled to undergo LND along the RLN. Patients will be randomly assigned to either RE or VATE. The primary outcome measure will be the rate of unsuccessful LND along the left RLN, which will be defined as 1) failure to remove lymph nodes along the left RLN or 2) occurrence of left RLN palsy following LND. Secondary outcomes will include the number of successfully removed RLN nodes, postoperative recovery, length of hospital stay, 30- and 90-day mortality, quality of life, and oncological outcomes.

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robot Esophagectomy (RE)

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

Group Type: EXPERIMENTAL

Robot esophagectomy (RE)

Intervention Type: DEVICE

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

Video-assisted thoracoscopic esophagectomy (VATE)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Robot esophagectomy (RE)

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age between 18~80

2. Histologically proven primary intrathoracic esophageal squamous cell carcinoma and will undergo McKeown MIE and bilateral RLN LND.

3. Patients should have a performance status 0, 1 or 2 according to the European Clinical Oncology Group.

4. Surgical resectable(cT1~4a, N0~3, M0)

5. Written informed consent

Exclusion Criteria

1. Previous major thoracic surgery rendering minimal invasive approach unfeasible

2. prognosis determining malignancy other than esophageal cancer, inability to undergo curative resection and/or follow-up

3. inability to provide oral or written informed consent.

4. pre-existed vocal cord dysfunction will also be excluded.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Chest Hospital

OTHER

Sponsor Role: collaborator

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chang Gung memorial hospital-Linkou

Taoyuan District, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Facility Contacts

Yin-Kai Chao

Role: primary

chaoyk@gmail.com

+886-3-3281200 ext. 3633

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Other Identifiers

201800322A3C601

Identifier Type: -

Identifier Source: org_study_id