Journal of thoracic disease · 2025
Feasibility and safety of outside the cage subcostal robotic anatomical lung resections: results of a phase I clinical trial.
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Bulgarelli Maqueda Luciano, Guimarães Rocha Lima Pedro, Abu-Reida Feras, Alashgar Omniyah, Têtu Maxime, Nasir Basil, Ferraro Pasquale, Liberman Moishe
Аннотация
BACKGROUND: The utilization of robotic-assisted thoracic surgery (RATS) for lung resections is increasing worldwide due to its minimally invasive footprint and relative ease compared to other approaches. However, current standard approaches to lobectomy using multiport robotic platforms involve trocar placement through the intercostal space(s), with resulting postoperative pain-related complications and the potential for chronic pain. In order to avoid instrumentation between the ribs and potential damage to the intercostal nerve bundle(s), we developed a non-intercostal, outside the thoracic cage (OTC) approach for RATS anatomical pulmonary resections. In this study we evaluated the safety, feasibility and postoperative outcomes associated with this technique.
METHODS: The study consisted of a prospective phase 1 clinical trial (NCT05832112) to evaluate safety and feasibility of the OTC technique. Patients planned to undergo minimally invasive lobectomy for resectable lung cancer were prospectively enrolled. Conversion rate and 30-day mortality were the primary outcome measures.
RESULTS: A total of 20 cases were analyzed. There were no conversions. There was no mortality at 30 days which represent respectively, the feasibility and safety primary outcome measures in this study. The median age of the patients was 63 [33-79] years, with a mean body mass index (BMI) of 28.6 [21.16-44.12] kg/m2 and a median American Society of Anesthesiologists (ASA) score of III [II-IV]. The clinical stage of 18 of the patients was stage I and two patients were clinical stage IIIA having undergone neoadjuvant chemo-immunotherapy (NACT/IO) induction prior to surgery. The mean operative time (OT) was 109 [70-149] minutes. Blood loss was minimal (<50 mL) in 80% of the cases, overall mean blood loss was 56 [45-200] mL. The median length of hospital stay (LOS) was 2 days with a median duration of chest tube (DCT) of 1 day and no readmissions following discharge. Perioperative complications were observed in 25% of the patients (n=5). There were 4 cases of prolonged air leak (PAL) requiring extended LOS or discharge with chest tube with 1 of these patients presenting with a pneumothorax after chest tube removal which required pigtail insertion (Clavien-Dindo ≥III). The remaining patient experiencing a complication presented with a wound infection that did not require reintervention. In the vast majority of the cases (n=17, 85%) the quality of recovery (QOR) 48 hours after the procedure was reported as moderate, good or excellent. Only 15% (n=3) of the patients described severe pain and a poor QOR at 48 hours post-op.
CONCLUSIONS: The RATS OTC technique for anatomic pulmonary resection was feasible and safe for patients with resectable non-small cell lung cancer (NSCLC) planned to undergo minimally invasive surgery (MIS) lobectomy in our center. Comparative and multi-center studies are needed to further assess the benefits, generalizability, and actual clinical relevance of this novel surgical approach.
METHODS: The study consisted of a prospective phase 1 clinical trial (NCT05832112) to evaluate safety and feasibility of the OTC technique. Patients planned to undergo minimally invasive lobectomy for resectable lung cancer were prospectively enrolled. Conversion rate and 30-day mortality were the primary outcome measures.
RESULTS: A total of 20 cases were analyzed. There were no conversions. There was no mortality at 30 days which represent respectively, the feasibility and safety primary outcome measures in this study. The median age of the patients was 63 [33-79] years, with a mean body mass index (BMI) of 28.6 [21.16-44.12] kg/m2 and a median American Society of Anesthesiologists (ASA) score of III [II-IV]. The clinical stage of 18 of the patients was stage I and two patients were clinical stage IIIA having undergone neoadjuvant chemo-immunotherapy (NACT/IO) induction prior to surgery. The mean operative time (OT) was 109 [70-149] minutes. Blood loss was minimal (<50 mL) in 80% of the cases, overall mean blood loss was 56 [45-200] mL. The median length of hospital stay (LOS) was 2 days with a median duration of chest tube (DCT) of 1 day and no readmissions following discharge. Perioperative complications were observed in 25% of the patients (n=5). There were 4 cases of prolonged air leak (PAL) requiring extended LOS or discharge with chest tube with 1 of these patients presenting with a pneumothorax after chest tube removal which required pigtail insertion (Clavien-Dindo ≥III). The remaining patient experiencing a complication presented with a wound infection that did not require reintervention. In the vast majority of the cases (n=17, 85%) the quality of recovery (QOR) 48 hours after the procedure was reported as moderate, good or excellent. Only 15% (n=3) of the patients described severe pain and a poor QOR at 48 hours post-op.
CONCLUSIONS: The RATS OTC technique for anatomic pulmonary resection was feasible and safe for patients with resectable non-small cell lung cancer (NSCLC) planned to undergo minimally invasive surgery (MIS) lobectomy in our center. Comparative and multi-center studies are needed to further assess the benefits, generalizability, and actual clinical relevance of this novel surgical approach.