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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
212

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 22, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 22, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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