Comparing Robotic and Open Surgery for Pancreatoduodenectomy in Pancreatic Cancer Across Multiple Spanish Hospitals

What this Trial Is About

Pancreatoduodenectomy PD, also known as the Whipple procedure, is a complex surgery often required for pancreatic and other periampullary cancers. This national, multicenter study in Spain compares robotic-assisted PD to traditional open PD surgery. The aim is to evaluate which surgical approach results in fewer complications within 90 days after surgery. The study uses a prospective, randomized design and involves multiple hospitals with experienced surgeons. Participants will be randomly assigned to either robotic or open PD surgery. The robotic approach uses the da Vinci system for the pancreatic and biliary connections, while the open approach follows standard laparotomy procedures. The study lasts two years, and patients will be followed for three years to assess long-term outcomes. Both techniques will be monitored for complications, blood loss, operative time, conversion rates, and oncological outcomes among cancer patients. During the study, participants will undergo surgery according to their assigned group. Data on complications, quality of life, hospital stay duration, surgical costs, and recovery will be collected using standardized scales and questionnaires up to 90 days and beyond. Follow-up includes monitoring for readmissions, need for reoperations, and long-term tumor outcomes. Safety and economic data will also be recorded, with confidentiality maintained through coded patient data. The total participation may last several years to capture extended outcomes.

Robotic vs Open Pancreatoduodenectomy