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

作者：Pieter Christiaan van der Sluis, Jelle P. H. Ruurda, Sylvia van der Horst, Roy J.J. Verhage, Marc G. Besselink, M.J.D. Prins, Leonie Haverkamp, Carlo Schippers, Inne HM Borel Rinkes, Hans C. A. Joore, Fiebo J. ten Kate, Hendrik Koffijberg, Christiaan Kroese, Maarten Simon van Leeuwen, Martijn P. Lolkema, Onne Reerink, Marguerite E I Schipper, Elles Steenhagen, Frank P. Vleggaar, Emile E. Voest, Peter Derk Siersema, Richard van Hillegersberg · 发表于：Trials · 年份：2012 · DOI：10.1186/1745-6215-13-230 · 被引用次数：181 · 研究领域：Esophageal Cancer Research and Treatment、Gastrointestinal Tumor Research and Treatment、Colorectal and Anal Carcinomas

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 obtainin...