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Robot-assisted Ivor-lewis Esophagectomy: A Single-center, Single-arm, Phase 2 Clinical Study (raile Trial)
Yuqin Cao, Yajie Zhang, Dong Dong, Yu Han, Chengqiang Li, Hecheng Li.
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
BACKGROUND: Minimally invasive esophagectomy (MIE) has emerged as an alternative to open esophagectomy (OE) for the recent decade. Nowadays, robot-assisted procedures are utilized more and more frequently for the treatment of esophageal cancer. However, the safety and oncological outcomes of robot-assisted Ivor-Lewis esophagectomy (RAILE) has not been prospectively assessed.
METHODS: RAILE trial was designed as a prospective, single-center, single-arm, open label clinical trial to evaluate the safety and survival outcomes of RAILE for esophageal cancer (ClinicalTrials.gov identifier: NCT03140189). The primary outcome is the morbidity of major complications after surgery (Clavien-Dindo Class ≥ III). The secondary endpoints included perioperative outcomes (morbidity of overall, minor, and specific complications, rate of reoperations, 30- and 90-day mortality, and rate of readmission within 30 day), and long-term survival data (3-year overall and disease-free survival).
RESULTS: Between May 2017 and July 2019, a total of 51 patients with esophageal squamous cell carcinoma were enrolled. Operative time was 282±45.2 min, with estimated blood loss of 199.2±110.8 ml. Only 1 (2.0%) patient underwent conversion. Rate of major and overall complications were 11.8% and 37.3%, respectively. No mortality occurred within 30 days and 1 (2.0%) death within 90 days. Four (7.8%) patients underwent readmission within 30 days. A total of 50 (98.0%) patients achieved R0 resection. The 3-year overall and disease-free survival rate were 69.9% and 65.9%, respectively.
CONCLUSIONS: RAILE is safe and feasible for the treatment of esophageal cancer, along with an acceptable morbidity of major complications and long-term survival.
LEGEND: Long-term survival of 51 patients in RAILE trial. (A) 3-year overall survival: (B) 3-year disease-free survival.
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