A Prospective, Single-Center Investigation of the da Vinci SP Surgical System in Hepatopancreaticobiliary and Foregut Operations for Benign and Malignant Disease

What this Trial Is About

Researchers are evaluating the safety and performance of the da Vinci SP Surgical System, Instruments, and Accessories in hepatopancreaticobiliary (HPB) and foregut surgeries. These operations include cholecystectomy, fundoplication, gastrectomy, distal pancreatectomy, pancreaticoduodenectomy, esophagectomy, and hepatectomy for both benign and malignant diseases. The study aims to collect data on the system's use in these complex surgical procedures at a single center. The study is divided into four stages based on the participant's diagnosis and the type of operation. Each participant will undergo one operation using the da Vinci SP-assisted Single Port Robot. Stage One involves cholecystectomy and hiatal hernia repair with fundoplication. Stage Two includes gastrectomy and distal pancreatectomy. Stage Three covers pancreaticoduodenectomy and esophagectomy. Stage Four involves hepatectomy. The da Vinci SP system uses a minimally invasive single-port approach with a surgeon console, vision cart, patient cart, camera, instruments, and accessories. During the study, participants will be monitored for completion of surgery using the planned robotic system, intraoperative and postoperative adverse events, positive resection margins, and lymph node yield over periods up to 24 months. Additional assessments include physical status, comorbidity scores, operative time, blood loss, complications, mortality, discharge date, survival, disease recurrence, and readmission rates. Follow-up extends annually through five years to evaluate long-term outcomes and safety. Participants will be observed closely to collect comprehensive surgical and recovery data.

A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Hepatopancreaticobiliary and Foregut Operations for Benign and Malignant Disease