Robotic vs Thoracolaparoscopic Esophagectomy for Esophageal Cancer: A Randomized Clinical Trial.

IMPORTANCE

The optimal surgical approach for oncological thoracoabdominal esophagectomy for adenocarcinoma is unclear. Robot-assisted minimally invasive esophagectomy (RAMIE) may facilitate a more extensive lymphadenectomy compared with conventional minimally invasive esophagectomy (MIE), which is crucial to achieve a favorable oncological outcome.

OBJECTIVE

To determine whether RAMIE results in a higher yield of resected lymph nodes compared with conventional MIE in patients undergoing surgery for esophageal or esophagogastric junction adenocarcinoma.

DESIGN, SETTING, AND

PARTICIPANTS

This was a phase 3 randomized clinical trial conducted between January 2021 and March 2025 at 4 high-volume tertiary referral centers in Mainz, Germany; Amsterdam, the Netherlands; Zurich, Switzerland; and Cologne, Germany. Patients with resectable adenocarcinoma of the esophagus or esophagogastric junction staged as cT1-4a, cN0-3, and cM0 were included. Both primary surgery and multimodal treatment settings were eligible. A total of 218 patients were initially randomized, 202 of whom completed the study and underwent transthoracic esophagectomy with follow-up up to 5 years.

INTERVENTIONS: Participants were randomly assigned (1:1) to RAMIE or conventional MIE.

MAIN OUTCOMES AND MEASURES: The primary end point was the number of resected lymph nodes, planned a priori and analyzed on a modified intention-to-treat basis. Secondary measures included luminal R0 resection rates, postoperative complication rates, 90-day mortality, and 1-year survival.

RESULTS

Between 2021 and 2025, 218 patients were included in the study, 202 of whom (mean [SD] age, 64.8 [10.1] years; 181 [89.6%] male) underwent transthoracic esophagectomy (101 RAMIE and 101 MIE). The median number of resected lymph nodes was significantly higher in RAMIE compared to MIE (36 vs 32; P = .005). Luminal R0 resection was 99.0% with RAMIE and 97.0% with MIE. Rates of postoperative complications were similar between groups; 90-day mortality was 1.0% in the RAMIE group and 3.0% in the MIE group (P = .62). There was no difference in survival after 1 year.

CONCLUSIONS AND RELEVANCE: In this study, robotic esophagectomy provided a more radical lymphadenectomy compared to conventional minimally invasive esophagectomy with equal results for surgical safety. These results support the use of robotic esophagectomy as a standard approach for adenocarcinoma of the esophagus or esophagogastric junction.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04306458.