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Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy versus open transthoracic esophagectomy for resectable esophageal cancer, a randomized controlled trial (ROBOT trial)

Pieter C van der Sluis1*, Jelle P Ruurda1, Sylvia van der Horst1, Roy JJ Verhage1, Marc GH Besselink1, Margriet JD Prins1, Leonie Haverkamp1, Carlo Schippers1, Inne HM Borel Rinkes1, Hans CA Joore2, Fiebo JW ten Kate3, Hendrik Koffijberg4, Christiaan C Kroese5, Maarten S van Leeuwen6, Martijn PJK Lolkema7, Onne Reerink8, Marguerite EI Schipper3, Elles Steenhagen4, Frank P Vleggaar9, Emile E Voest7, Peter D Siersema9 and Richard van Hillegersberg1*

Author Affiliations

1 Department of Surgery, G04.228, University Medical Center Utrecht, Heidelberglaan 100, Utrecht, CX, 3584, the Netherlands

2 Department of Intensive Care Medicine, University Medical Center Utrecht, Heidelberglaan 100, Utrecht, CX, 3584, the Netherlands

3 Department of Pathology, University Medical Center Utrecht, Heidelberglaan 100, Utrecht, CX, 3584, the Netherlands

4 Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Heidelberglaan 100, Utrecht, CX, 3584, the Netherlands

5 Department of Anesthesiology, University Medical Center Utrecht, Heidelberglaan 100, Utrecht, CX, 3584, the Netherlands

6 Department of Radiology, University Medical Center Utrecht, Heidelberglaan 100, Utrecht, CX, 3584, the Netherlands

7 Department of Medical Oncology, University Medical Center Utrecht, Heidelberglaan 100, Utrecht, CX, 3584, the Netherlands

8 Department of Radiotherapy, University Medical Center Utrecht, Heidelberglaan 100, Utrecht, CX, 3584, the Netherlands

9 Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Heidelberglaan 100, Utrecht, CX, 3584, the Netherlands

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Trials 2012, 13:230  doi:10.1186/1745-6215-13-230

Published: 30 November 2012

Abstract

Background

For esophageal cancer patients, radical esophagolymphadenectomy is the cornerstone of multimodality treatment with curative intent. Transthoracic esophagectomy is the preferred surgical approach worldwide allowing for en-bloc resection of the tumor with the surrounding lymph nodes. However, the percentage of cardiopulmonary complications associated with the transthoracic approach is high (50 to 70%).

Recent studies have shown that robot-assisted minimally invasive thoraco-laparoscopic esophagectomy (RATE) is at least equivalent to the open transthoracic approach for esophageal cancer in terms of short-term oncological outcomes. RATE was accompanied with reduced blood loss, shorter ICU stay and improved lymph node retrieval compared with open esophagectomy, and the pulmonary complication rate, hospital stay and perioperative mortality were comparable. The objective is to evaluate the efficacy, risks, quality of life and cost-effectiveness of RATE as an alternative to open transthoracic esophagectomy for treatment of esophageal cancer.

Methods/design

This is an investigator-initiated and investigator-driven monocenter randomized controlled parallel-group, superiority trial. All adult patients (age ≥18 and ≤80 years) with histologically proven, surgically resectable (cT1-4a, N0-3, M0) esophageal carcinoma of the intrathoracic esophagus and with European Clinical Oncology Group performance status 0, 1 or 2 will be assessed for eligibility and included after obtaining informed consent. Patients (n = 112) with resectable esophageal cancer are randomized in the outpatient department to either RATE (n = 56) or open three-stage transthoracic esophageal resection (n = 56). 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.

Discussion

This is the first randomized controlled trial designed to compare RATE with open transthoracic esophagectomy as surgical treatment for resectable esophageal cancer. If our hypothesis is proven correct, RATE will result in a lower percentage of postoperative complications, lower blood loss, and shorter hospital stay, but with at least similar oncologic outcomes and better postoperative quality of life compared with open transthoracic esophagectomy. The study started in January 2012. Follow-up will be 5 years. Short-term results will be analyzed and published after discharge of the last randomized patient.

Trial registration

Dutch trial register: NTR3291 ClinicalTrial.gov: NCT01544790