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

June 28, 2021 updated by: Chang Gung Memorial Hospital

Robotic-assisted Esophagectomy vs. Video-Assisted Thoracoscopic Esophagectomy(REVATE) : a Multicenter Open-label Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

212

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital-Linkou
        • Contact:
        • Principal Investigator:
          • Yin Kai Chao, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robot Esophagectomy (RE)
Patients in the RE group will receive robotic-assisted esophagectomy with standard total two-field lymphadenectomy.
Device: Robot esophagectomy (RE)
Patients in RE group will receive Robotic-assisted surgery in thoracic phase.
No Intervention: Video-assisted thoracoscopic esophagectomy (VATE)
Patients in the VATE group will receive thoracoscopic esophagectomy with standard total two-field lymphadenectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Till 6 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The pathological analysis will be finished within 2 weeks.
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.
Duration of hospital stay, an expected average of 2~3 weeks
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
Duration of hospital stay, an expected average of 2~3 weeks
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
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
Time Frame: The pathological analysis will be finished within 2 weeks.
Microscopically negative proximal/distal and circumferential margin
The pathological analysis will be finished within 2 weeks.
Operation time(thoracic phase)
Time Frame: Day of surgery
thoracic phase operation time(minutes)
Day of surgery
Operation time(abdominal)
Time Frame: Day of surgery
abdominal phase operation time(minutes)
Day of surgery
Total operation time
Time Frame: Day of surgery
total surgical time (expressed in minutes)
Day of surgery
Unexpected events and complications occurring during surgery
Time Frame: Day of surgery, up to 24 hours after surgery.
massive hemorrhage, perforation of other organs
Day of surgery, up to 24 hours after surgery.
Blood loss during surgery
Time Frame: Day of surgery, up to 24 hours after surgery.
blood loss during surgery (expressed in mL per phase)
Day of surgery, up to 24 hours after surgery.
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
Day of surgery, up to 24 hours after surgery.
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
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
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks
expressed in hours
Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks
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
Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks
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
Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks
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
Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks
Overall survival rate
Time Frame: Assessed 24/36/60 months after surgery
From date of surgery until the date of death from any cause
Assessed 24/36/60 months after surgery
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
Assessed up to 24/36/60 months after surgery
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.
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
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.
pre-operative < 5 days and 4 weeks, 3/6 months and yearly up to 5 years post-operatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Collaborators

Tianjin Medical University Cancer Institute and Hospital
Shanghai Chest Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2018

Primary Completion (Anticipated)

April 22, 2022

Study Completion (Anticipated)

December 22, 2022

Study Registration Dates

First Submitted

October 11, 2018

First Submitted That Met QC Criteria

October 17, 2018

First Posted (Actual)

October 22, 2018

Study Record Updates

Last Update Posted (Actual)

July 1, 2021

Last Update Submitted That Met QC Criteria

June 28, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201800322A3C601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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