Robot-assisted Thoraco-laparoscopic Esophagectomy Versus Open Transthoracic Esophagectomy
Condition: Esophageal Carcinoma; Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      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).
    

Detailed description: 
      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
    

Intervention name(s): Esophagectomy
Intervention type(s): Procedure
Intervention description(s): In this monocenter prospective randomized controlled trial, we compare robot-assisted minimally invasive esophagectomy with conventional open transthoracic esophagectomy.
Other intervention name(s): robot-assisted minimally invasive esophagectomy; robot-assisted thoraco-laparoscopic esophagectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Esophageal carcinoma; Esophageal cancer; Robotic surgery; Esophagectomy; Minimally invasive