Esophageal Cancer Clinical Trial
Official title:
Robot-assisted Minimally Invasive Thoraco-laparoscopic Esophagectomy Versus Open Transthoracic Esophagectomy for Resectable Esophageal Cancer. The ROBOT-trial: a Monocenter Randomized Controlled Trial.
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).
Rationale: As stated in the 2010 revised Dutch esophageal carcinoma guidelines, the golden
standard for surgical treatment of esophageal carcinoma is open transthoracic esophagectomy.
Recent evidence suggests that robot-assisted thoraco-laparoscopic esophagectomy using the Da
Vinci ® robot can provide an extensive resection, with possibly better or at least equal
radical (R0) resection rates and an equal number of dissected lymph nodes. This is
accompanied with markedly reduced blood loss and reduction of overall complications with
shorter intensive care unit (ICU) and hospital stay. Therefore, the robot-assisted
thoraco-laparoscopic esophagectomy is now at a stage that it should be compared to the
current standard of care in a randomized controlled trial.
Objective: Evaluate the benefits, risks and costs of robot-assisted thoraco-laparoscopic
esophagectomy as an alternative to open transthoracic esophagectomy as treatment for
esophageal cancer.
Study design: Randomized controlled parallel-group superiority trial Study population:
Patients (age ≥ 18 and ≤ 75 jaar) with histologically proven surgically resectable (cT1-4a,
N0-3, M0) squamous cell carcinoma, adenocarcinoma or undifferentiated esophageal carcinoma of
the intrathoracic esophagus with European Clinical Oncology Group (ECOG) status 0, 1 or 2.
Intervention: 112 patients will be randomly allocated to either A) robot-assisted
thoraco-laparoscopic esophagectomy (n=56) or B) open transthoracic esophagectomy (n=56).
Patients will receive the following interventions:
Group A. Robot-assisted thoraco-laparoscopic esophagectomy, with gastric conduit formation.
Group B. Open transthoracic esophagectomy, with gastric conduit formation.
Main study parameters/endpoints: Primary outcome is the percentage of overall complications
(Grade 2 and higher) as stated by the modified Clavien-Dindo classification (MCDC).
Secondary outcomes are individual components of the primary endpoint (major and minor
complications), (in hospital) mortality within 30 and 60 days, R0 resections, operation
related events, postoperative recovery, oncologic outcomes, cost-effectiveness and quality of
life.
Follow-up: 60 months after randomization
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