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

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ClinicalTrials.gov Identifier: NCT03713749
Recruitment Status : Recruiting
First Posted : October 22, 2018
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Tracking Information
First Submitted Date  ICMJE October 11, 2018
First Posted Date  ICMJE October 22, 2018
Last Update Posted Date November 26, 2018
Actual Study Start Date  ICMJE October 22, 2018
Estimated Primary Completion Date April 22, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2018)
Rate of unsuccessful LND along the left RLN [ Time Frame: Till 6 months postoperatively ]
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)
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2018)
Rate of unsuccessful LND along the left RLN [ Time Frame: Till 6 months postoperatively ]
Regardless of the presence of hoarseness, vocal cord function will be assessed by an experienced otolaryngologist using a flexible 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)
Change History Complete list of historical versions of study NCT03713749 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2018)
  • The number of nodes removed along the right and left RLN [ Time Frame: The pathological analysis will be finished within 2 weeks. ]
    number of lymph node removed
  • Post esophagectomy pneumonia rate [ Time Frame: Duration of hospital stay, an expected average of 2~3 weeks ]
    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.
  • Rate of major postoperative complication [ Time Frame: Duration of hospital stay, an expected average of 2~3 weeks ]
    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
  • In hospital, 30 day and 90 day mortality [ 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 ]
    Death occurred during the same hospitalization , within 30 and 90 days after surgery
  • R0 resection rate [ Time Frame: The pathological analysis will be finished within 2 weeks. ]
    Microscopically negative proximal/distal and circumferential margin
  • Operation time(thoracic phase) [ Time Frame: Day of surgery ]
    thoracic phase operation time(minutes)
  • Operation time(abdominal) [ Time Frame: Day of surgery ]
    abdominal phase operation time(minutes)
  • Total operation time [ Time Frame: Day of surgery ]
    total surgical time (expressed in minutes)
  • Unexpected events and complications occurring during surgery [ Time Frame: Day of surgery, up to 24 hours after surgery. ]
    massive hemorrhage, perforation of other organs
  • Blood loss during surgery [ Time Frame: Day of surgery, up to 24 hours after surgery. ]
    blood loss during surgery (expressed in mL per phase)
  • Rate of thoracotomy conversion [ Time Frame: Day of surgery, up to 24 hours after surgery. ]
    Number of patients requiring conversion to thoracotomy and related reasons
  • Length of mechanical ventilator use after surgery [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks ]
    expressed in minutes
  • Length of intensive care unit stay after surgery [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks ]
    expressed in hours
  • Length of postoperative hospital stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks ]
    expressed in days , calculated from the date of surgery to date of discharge
  • Re-intubation rate [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks ]
    Need for re-intubation after extubation
  • Re-entry ICU rate [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks ]
    Need to transfer back from ward to ICU after surgery
  • Overall survival rate [ Time Frame: Assessed 24/36/60 months after surgery ]
    From date of surgery until the date of death from any cause
  • Disease free survival rate [ Time Frame: Assessed up to 24/36/60 months after surgery ]
    From date of surgery until the date of first documented recurrence
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: pre-operative < 5 days and 4 weeks, 3/6 months and yearly up to 5 years post-operatively. ]
    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.
  • European Organisation for Research and Treatment of Cancer(EORTC) QLQ-C30 , QLQ-OES18 [ Time Frame: pre-operative < 5 days and 4 weeks, 3/6 months and yearly up to 5 years post-operatively. ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2018)
  • The number of nodes removed along the right and left RLN [ Time Frame: The pathological analysis will be finished within 2 weeks. ]
    number of lymph node removed
  • Post esophagectomy pneumonia rate [ Time Frame: Duration of hospital stay, an expected average of 2~3 weeks ]
    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.
  • Rate of major postoperative complication [ Time Frame: Duration of hospital stay, an expected average of 2~3 weeks ]
    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
  • In hospital, 30 day and 90 day mortality [ 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 ]
    Death occurred during the same hospitalization , within 30 and 90 days after surgery
  • R0 resection rate [ Time Frame: The pathological analysis will be finished within 2 weeks. ]
    Microscopically negative proximal/distal and circumferential margin
  • Operation time(thoracic phase) [ Time Frame: Day of surgery ]
    thoracic phase operation time(minutes)
  • Operation time(abdominal) [ Time Frame: Day of surgery ]
    abdominal phase operation time(minutes)
  • Total operation time [ Time Frame: Day of surgery ]
    total surgical time (expressed in minutes)
  • Unexpected events and complications occurring during surgery [ Time Frame: Day of surgery, up to 24 hours after surgery. ]
    massive hemorrhage, perforation of other organs
  • Blood loss during surgery [ Time Frame: Day of surgery, up to 24 hours after surgery. ]
    blood loss during surgery (expressed in mL per phase)
  • Rate of thoracotomy conversion [ Time Frame: Day of surgery, up to 24 hours after surgery. ]
    Number of patients requiring conversion to thoracotomy and related reasons
  • Length of mechanical ventilator use after surgery [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks ]
    expressed in minutes
  • Length of intensive care unit stay after surgery [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks ]
    expressed in hours
  • Lengh of postoperative hospital stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks ]
    expressed in days , calcluated from the date of surgery to date of discharge
  • Re-intubation rate [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks ]
    Need for re-intubation after extubation
  • Re-entry ICU rate [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks ]
    Need to transfer back from ward to ICU after surgery
  • Overall survival rate [ Time Frame: Assessed 24/36/60 months after surgery ]
    From date of surgery until the date of death from any cause
  • Disease free survival rate [ Time Frame: Assessed up to 24/36/60 months after surgery ]
    From date of surgery until the date of first documented recurrence
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: pre-operative < 5 days and 4 weeks, 3/6 months and yearly up to 5 years post-operatively. ]
    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.
  • European Organisation for Research and Treatment of Cancer(EORTC) QLQ-C30 , QLQ-OES18 [ Time Frame: pre-operative < 5 days and 4 weeks, 3/6 months and yearly up to 5 years post-operatively. ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Robotic-assisted Esophagectomy vs. Video-Assisted Thoracoscopic Esophagectomy(REVATE) Trial
Official Title  ICMJE Robotic-assisted Esophagectomy vs. Video-Assisted Thoracoscopic Esophagectomy(REVATE) : a Multicenter Open-label Randomized Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Esophageal Squamous Cell Carcinoma
Intervention  ICMJE Device: Robot esophagectomy (RE)
Patients in RE group will receive Robotic-assisted surgery in thoracic phase.
Study Arms  ICMJE
  • Experimental: Robot Esophagectomy (RE)
    Patients in the RE group will receive robotic-assisted esophagectomy with standard total two-field lymphadenectomy.
    Intervention: Device: Robot esophagectomy (RE)
  • No Intervention: Video-assisted thoracoscopic esophagectomy (VATE)
    Patients in the VATE group will receive thoracoscopic esophagectomy with standard total two-field lymphadenectomy.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 17, 2018)
212
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 22, 2022
Estimated Primary Completion Date April 22, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03713749
Other Study ID Numbers  ICMJE 201800322A3C601
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Chang Gung Memorial Hospital
Study Sponsor  ICMJE Chang Gung Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chang Gung Memorial Hospital
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP