Esophageal Cancer Clinical Trial
— ROBOTOfficial title:
Robot-assisted Minimally Invasive Thoraco-laparoscopic Esophagectomy Versus Open Transthoracic Esophagectomy for Resectable Esophageal Cancer. The ROBOT-trial: a Monocenter Randomized Controlled Trial.
Verified date | March 2020 |
Source | UMC Utrecht |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is the first randomized controlled trial designed to compare robot-assisted minimally
invasive thoraco-laparoscopic esophagectomy with open transthoracic esophagectomy as surgical
treatment for resectable esophageal cancer.
If our hypothesis is proved correct, robot-assisted minimally invasive thoraco-laparoscopic
esophagectomy will result in a lower percentage of postoperative complications, lower blood
loss, shorter hospital stay, but with at least similar oncologic outcomes and better
postoperative quality of life compared with the open transthoracic esophagectomy (current
standard).
Status | Completed |
Enrollment | 112 |
Est. completion date | August 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus. - Surgical resectable (T1-4a, N0-3, M0) - Age = 18 and = 75 years - European Clinical Oncology Group (ECOG) performance status 0,1 or 2 - Written informed consent Exclusion Criteria: - Carcinoma of the cervical esophagus - Carcinoma of the gastro-esophageal junction (GEJ) with major tumor in the gastric cardia (Siewert III) - Prior thoracic surgery at the right hemithorax or thorax trauma (rationale: these patients will undergo open resection) |
Country | Name | City | State |
---|---|---|---|
Netherlands | UMC Utrecht | Utrecht |
Lead Sponsor | Collaborator |
---|---|
UMC Utrecht |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative complications modified Clavien-Dindo classification (MCDC) grade 2 and higher | The primary outcome of this study is the percentage of overall complications (Grade 2 and higher) as stated by the modified Clavien-Dindo classification of surgical complications (MCDC) | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks | |
Secondary | Individual components of the primary endpoint (major and minor complications) | 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 (Vivonex®), gastric tube necrosis (proven by gastroscopy), pulmonary embolus, deep vein thrombosis, vocal cord palsy or paralysis. Minor complications (MCDC grade 1) Including: wound infections, pleural effusions, delayed gastric emptying |
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks | |
Secondary | (In hospital) Mortality within 30 and 60 days | (In hospital) mortality and mortality within 30 and 60 days will be reported. The cause of death and the results of the autopsy report will be noted. | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks and within 30 days or 60 days | |
Secondary | R0 resections (%) | The pathological analysis will be finished within 2 weeks. | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks | |
Secondary | Operation related events | Operation time is defined as time from incision until closure (minutes) for both the thoracic and the abdominal phase of the procedure. For the robotic procedure, set up time will be recorded separately. Unexpected events and complications occurring during the operation will be recorded (e.g. massive hemorrhage, perforation of other organs). Blood loss during operation (ml, per phase). In case of conversion to thoracotomy or laparotomy the reason for conversion has to be explained (absolute numbers/percentage). |
Day of surgery, up to 24 hours after surgery. | |
Secondary | Postoperative recovery | Pain: Type and dose of used analgesics will be noted during the hospital admission period. Visual Analogue Scale (VAS) for pain will be noted at following times: pre-operatively and the first 10 days after surgery and a fixed periods during follow up (6 weeks, 6 months and yearly post-operatively up to 5 years). Length of intensive care unit (ICU) - medium care unit (MCU) stay (days). Length of hospital stay (days). |
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks | |
Secondary | Oncologic outcomes | 2, 3 and 5 year disease free and overall survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months after surgery. | |
Secondary | Quality of life | Questionnaires will be required at following times: SF-36, EORTC QLQ-C30 (Dutch), EORTC OES18 (Dutch) and EQ-5D (Appendix 1 & 2) pre-operative < 5 days and 6 weeks, 6 months and yearly up to 5 years post-operatively. |
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months after surgery. | |
Secondary | Costs (euro) | Direct general costs, due to extra operating room time and extra instruments. Indirect costs, such as reduced ICU or hospital stay. | 5 years follow up |
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