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

Chang Gung Medical Foundation

Status: Unknown

Conditions: Esophageal Squamous Cell Carcinoma

Treatments: Device: Robot esophagectomy (RE)

Study type: Interventional

Funder types: Other

Identifiers

NCT03713749

201800322A3C601

Details and patient eligibility

About

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.

Full 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.

Enrollment: 212 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 are

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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212 participants in 2 patient groups

Robot Esophagectomy (RE)

Experimental group

Description:

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

Treatment:

Device: Robot esophagectomy (RE)

Video-assisted thoracoscopic esophagectomy (VATE)

No Intervention group

Description:

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