Robotic radical antegrade modular pancreatosplenectomy(RAMPS) versus standard retrograde pancreatosplenectomy (SRPS):study protocol for a randomized controlled trial

Abstract

Background There has been data from meta-analysis suggesting that RAMPS is a safe and effective procedure for adenocarcinoma in the body or tail of the pancreas and is oncologically superior to SRPS. However, previous studies on RAMPS were conducted under the open and laparoscopic surgery. Robotic surgery, on the other hand, plays a role in ergonomics and offers several advantages, including less fatigue, tremor filtering, 7° of wrist-like motion, motion scaling, and three-dimensional vision. At present, there is still a lack of clinical studies to observe the safety and clinical efficacy of Robotic RAMPS in the world. Hence,prospective randomized controlled trials (RCTs) comparing Robotic RAMPS and SRPS are required. We begin a RCT trial to compare short-term surgical and oncological outcomes of Robotic RAMPS and SRPS for patients with distal pancreatectomy.Methods This is a randomized, single-center clinical trial. All included adults are patients with primary carcinoma of the distal pancreatectomy. A total of 246 patients will be randomly allocated to Robotic RAMPS or SRPS. The primary endpoints are oncological outcomes(R0 rate, number of Lymph node). Secondary endpoints are the perioperative complications, Perioperative indicators(operative time,blood loss,blood transfusion volume,costs).Discussion To evaluate the surgical and oncological outcomes of Robotic RAMPS, we therefore undertake a prospective RCT. This procedure may become a standard approach to robotic pancreatosplenectomy.