Robot-assisted Thoraco-laparoscopic Esophagectomy Versus Open Transthoracic Esophagectomy
Conditions
Esophageal Carcinoma - Esophageal Cancer
Conditions: official terms
Esophageal Neoplasms
Conditions: Keywords
Esophageal carcinoma, Esophageal cancer, Robotic surgery, Esophagectomy, Minimally invasive
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Esophagectomy
Type: Procedure
Overall Status
Recruiting
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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)
Location
UMC Utrecht
Utrecht, Netherlands
Status: Recruiting
Contact: Richard van Hillegersberg, MD, PhD - +3188-7558074 - r.vanhillegersberg@umcutrecht.nl
Start Date
January 2012
Completion Date
January 2021
Sponsors
UMC Utrecht
Source
UMC Utrecht
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page