RAMIE Versus MIE for Resectable Esophageal Cancer, a Randomized Controlled Trial (ROBOT-2 Trial).

BACKGROUND: For patients with esophageal cancer, radical esophagectomy with 2-field lymphadenectomy is the cornerstone of the multimodality treatment with curative intent. Both, conventional minimally invasive esophagectomy (MIE) and robot assisted minimally invasive esophagectomy (RAMIE) were shown to be superior compared to open transthoracic esophagectomy considering postoperative complications. However, no randomized comparison was made until now to compare MIE to RAMIE OBJECTIVES: The objective is to evaluate the extent of lymph node dissection, efficacy, risks, quality of life and cost-effectiveness of RAMIE as an alternative to MIE as treatment for esophageal adenocarcinoma or adenocarcinoma of the gastroesophageal junction.. METHODS: This is an investigator-initiated and investigator-driven multicenter randomized controlled parallel-group, superiority trial. All adult patients (age ≥18 and ≤ 90 years) with histologically proven, surgically resectable (cT1-4a, N0-3, M0) adenocarcinoma of the intrathoracic esophagus or adenocarcinoma of the gastroesophageal junction with European Clinical Oncology Group performance status 0, 1 or 2 will be assessed for eligibility and included after obtaining informed consent. Patients (n=218) are randomized at the outpatient department to either RAMIE (n=109) or MIE (n=109). The primary outcome of this study is the total number of resected lymph nodes according to the TIGER classification for esophageal cancer lymphadenectomy. CONCLUSION: This is the first randomized controlled trial designed to compare RAMIE to MIE as surgical treatment for resectable adenocarcinoma of the intrathoracic esophagus or adenocarcinoma of the gastroesophageal junction in the Western World. If our hypothesis is proven correct, RAMIE will result in a better lymph node dissection compared to conventional MIE. The study started in September 2019. Follow up will be 5 years. Short term results will be analyzed and published after discharge of the last randomized patient.

Sex

All

Minimum age

18 Years

Maximum age

90 Years

Inclusion Criteria:

* Histologically proven adenocarcinoma of the intrathoracic esophagus and gastroesophageal junction (including Siewert I and II)
* Surgically resectable (T1-4a, N0-3, M0)
* Age ≥ 18 and ≤ 90 years
* European Clinical Oncology Group (ECOG) performance status 0,1 or 2
* Written informed consent

Exclusion Criteria:

* Esophageal squamous cell carcinoma
* Carcinoma of the cervical esophagus
* Carcinoma of the gastro-esophageal junction (GEJ) with the main part of the tumor in the gastric cardia (Siewert type III)
* Prior thoracic surgery at the right hemithorax or thoracic trauma

• DERIVEDGoense L, van der Sluis PC, van der Horst S, Tagkalos E, Grimminger PP, van Dijk W, Ruurda JP, van Hillegersberg R. Cost analysis of robot-assisted versus open transthoracic esophagectomy for resectable esophageal cancer. Results of the ROBOT randomized clinical trial. Eur J Surg Oncol. 2023 Oct;49(10):106968. doi: 10.1016/j.ejso.2023.06.020. Epub 2023 Jul 1. PMID 37423873
• DERIVEDTagkalos E, van der Sluis PC, Berlth F, Poplawski A, Hadzijusufovic E, Lang H, van Berge Henegouwen MI, Gisbertz SS, Muller-Stich BP, Ruurda JP, Schiesser M, Schneider PM, van Hillegersberg R, Grimminger PP. Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy versus minimally invasive esophagectomy for resectable esophageal adenocarcinoma, a randomized controlled trial (ROBOT-2 trial). BMC Cancer. 2021 Sep 26;21(1):1060. doi: 10.1186/s12885-021-08780-x. PMID 34565343