Staged introduction of a first-in-human concomitant robotic liver resection and cone-beam CT-guided percutaneous liver ablation in a hybrid operating room (HARMONY): an IDEAL stage 0/1 study

Objectives To perform the first-in-human concomitant robotic liver resection and cone-beam CT (CBCT)-guided ablation in a hybrid operating room (HARMONY). Design IDEAL stage 0/1 study outlining the preparatory steps and outcomes of the first-in-human HARMONY procedure. IDEAL stage 0 involved conceptualisation, team training and dry runs. The first HARMONY procedure was performed and the procedural technique is described in detail. Setting All procedures took place at a single academic medical centre. Participants Patients eligible for the HARMONY procedure are any adults eligible for combined ablation and resection of colorectal liver metastases. The HARMONY procedure was performed in a first patient. Outcomes of patients who underwent sequential robotic liver resection and CT hepatic arteriography-guided liver ablation in the preparatory phase are also reported. Intervention Concomitant robotic liver resection and CBCT-guided ablation in a hybrid operating room. Main outcome measures The primary outcome was technical feasibility of the HARMONY procedure defined as the technical success of both the robotic surgical resection and CBCT-guided ablation within the hybrid operating room. Results Between 2018 and 2024, 19 patients underwent sequential robotic liver resection and CT-guided ablation. Median interval between procedures was 4 days, with 36.8% treated during one admission. Intraoperative incidents occurred in three (15.8%) patients and two (10.5%) patients experienced severe complications requiring reintervention. The first-in-human HARMONY procedure was successfully completed without intraoperative complications. Conclusions The concomitant performance of robotic liver resection and CBCT-guided ablation is technically feasible in a hybrid operating room. Future studies should evaluate its reproducibility, safety and long-term outcomes. Trial registration number CCMO Research with human participants (NL-009169).