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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
212
Patients in RE group will receive Robotic-assisted surgery in thoracic phase.
Chang Gung memorial hospital-Linkou
Taoyuan District, Taiwan
RECRUITINGRate 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)
Time frame: Till 6 months postoperatively
The number of nodes removed along the right and left RLN
number of lymph node removed
Time frame: The pathological analysis will be finished within 2 weeks.
Post esophagectomy pneumonia rate
Post esophagectomy pneumonia is defined according to the Revised Uniform Pneumonia Score which includes temperature\[°C\](Range ≥ 36.1 and ≤ 38.4 =0, ≤ 36.0 and ≥ 38.5=1); leukocyte count \[×1000/uL\](≥ 4.0 and ≤ 11.0=0, \<4.0 or \>11.0=1); and pulmonary radiography(Range No infiltrate=0, Diffused or patchy infiltrate=1, Well-circumscribed infiltrate=2). A sum score of 2 points or higher, of which at least 1 point is assigned because of infiltrative findings on pulmonary radiography, indicates the presence of pneumonia.
Time frame: Duration of hospital stay, an expected average of 2~3 weeks
Rate of major postoperative complication
Complication grade: modified Clavien-Dindo classification (MCDC) grade 2-4 Major complications (MCDC grade 2-4) Including: myocardial infarction, anastomotic leakage (clinical or radiologic diagnosis), anastomotic stenosis, chylothorax (chylous leakage, presence of chylous in chest tubes or indication start medium chain triglycerides containing tube feeding, gastric tube necrosis (proven by gastroscopy), pulmonary embolus, deep vein thrombosis. Minor complications (MCDC grade 1) Including: wound infections, pleural effusions, delayed gastric emptying
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Time frame: Duration of hospital stay, an expected average of 2~3 weeks
In hospital, 30 day and 90 day mortality
Death occurred during the same hospitalization , within 30 and 90 days after surgery
Time frame: 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
Microscopically negative proximal/distal and circumferential margin
Time frame: The pathological analysis will be finished within 2 weeks.
Operation time(thoracic phase)
thoracic phase operation time(minutes)
Time frame: Day of surgery
Operation time(abdominal)
abdominal phase operation time(minutes)
Time frame: Day of surgery
Total operation time
total surgical time (expressed in minutes)
Time frame: Day of surgery
Unexpected events and complications occurring during surgery
massive hemorrhage, perforation of other organs
Time frame: Day of surgery, up to 24 hours after surgery.
Blood loss during surgery
blood loss during surgery (expressed in mL per phase)
Time frame: Day of surgery, up to 24 hours after surgery.
Rate of thoracotomy conversion
Number of patients requiring conversion to thoracotomy and related reasons
Time frame: Day of surgery, up to 24 hours after surgery.
Length of mechanical ventilator use after surgery
expressed in minutes
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks
Length of intensive care unit stay after surgery
expressed in hours
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks
Length of postoperative hospital stay
expressed in days , calculated from the date of surgery to date of discharge
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks
Re-intubation rate
Need for re-intubation after extubation
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks
Re-entry ICU rate
Need to transfer back from ward to ICU after surgery
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks
Overall survival rate
From date of surgery until the date of death from any cause
Time frame: Assessed 24/36/60 months after surgery
Disease free survival rate
From date of surgery until the date of first documented recurrence
Time frame: Assessed up to 24/36/60 months after surgery
Hospital Anxiety and Depression Scale (HADS)
The HADS aims to measure symptoms of anxiety and depression and consists of 14 items,seven items for the anxiety subscale and seven for the depression subscale. The questionnaire responses were analysed in the light of the results of this estimation of the severity of both anxiety and of depression. This enabled a reduction of the number of items in the questionnaire to just seven reflecting anxiety and seven reflecting depression.(Of the seven depression items five reflected aspects of reduction in pleasure response). Each item had been answered by the patient on a four point (0-3) response category so the possible scores ranged from 0 to 21 for anxiety and 0 to 21 for depression. a score of 0 to 7 for either subscale could be regarded as being in the normal range, a score of 11 or higher indicating probable presence ('caseness') of the mood disorder and a score of 8 to 10 being just suggestive of the presence of the respective state.
Time frame: pre-operative < 5 days and 4 weeks, 3/6 months and yearly up to 5 years post-operatively.
European Organisation for Research and Treatment of Cancer(EORTC) QLQ-C30 , QLQ-OES18
The EORTC QLQ-C30 incorporates a range of QOL issues in five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea/vomiting), a global health/QOL scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The EORTC QLQ-OES18 contains four symptom scales (dysphagia, eating disorders, reflux, and pain) and six single items (difficulty swallowing saliva, choking, dry mouth, taste disorder, cough, and speech-related issues). Each question has four response choices ranging from 1 (not at all) to 4 (very much), except for the global QOL scale, which has seven response options ranging from 1 (very poor) to 7 (excellent). All questionnaire responses are linearly transformed to scores from 0 to 100.
Time frame: pre-operative < 5 days and 4 weeks, 3/6 months and yearly up to 5 years post-operatively.