Clinical trial NCT03713749: Robotic-assisted Esophagectomy vs. Video-Assisted Thoracoscopic Esophagectomy(REVATE) Trial
Official title: Robotic-assisted Esophagectomy vs. Video-Assisted Thoracoscopic Esophagectomy(REVATE) : a Multicenter Open-label Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: Robotic esophagectomy
Video-assisted thoracoscopic esophagectomy
Recurrent laryngeal nerve lymh node
Esophageal squamous cell carcinoma
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Chest Hospital
name: Tianjin Medical University Cancer Institute and Hospital
First posted: 2018-10-22
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Rate of unsuccessful LND along the left RLN
timeFrame: Till 6 months postoperatively
Secondary outcomes:
measure: The number of nodes removed along the right and left RLN
timeFrame: The pathological analysis will be finished within 2 weeks.
measure: Post esophagectomy pneumonia rate
timeFrame: Duration of hospital stay, an expected average of 2~3 weeks
measure: Rate of major postoperative complication
timeFrame: Duration of hospital stay, an expected average of 2~3 weeks
measure: In hospital, 30 day and 90 day mortality
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks and within 30 days or 90 days
measure: R0 resection rate
timeFrame: The pathological analysis will be finished within 2 weeks.
measure: Operation time(thoracic phase)
timeFrame: Day of surgery
measure: Operation time(abdominal)
timeFrame: Day of surgery
measure: Total operation time
timeFrame: Day of surgery
measure: Unexpected events and complications occurring during surgery
timeFrame: Day of surgery, up to 24 hours after surgery.
measure: Blood loss during surgery
timeFrame: Day of surgery, up to 24 hours after surgery.
measure: Rate of thoracotomy conversion
timeFrame: Day of surgery, up to 24 hours after surgery.
measure: Length of mechanical ventilator use after surgery
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks
measure: Length of intensive care unit stay after surgery
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks
measure: Length of postoperative hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks
measure: Re-intubation rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks
measure: Re-entry ICU rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks
measure: Overall survival rate
timeFrame: Assessed 24/36/60 months after surgery
measure: Disease free survival rate
timeFrame: Assessed up to 24/36/60 months after surgery
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: pre-operative < 5 days and 4 weeks, 3/6 months and yearly up to 5 years post-operatively.
measure: European Organisation for Research and Treatment of Cancer(EORTC) QLQ-C30 , QLQ-OES18
timeFrame: pre-operative < 5 days and 4 weeks, 3/6 months and yearly up to 5 years post-operatively.
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung memorial hospital-Linkou
Study officials:
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