Abstract
BackgroundData from meta-analysis suggest that robotic radical antegrade modular pancreatosplenectomy (RAMPS) is a safe and effective procedure for treating adenocarcinoma in the body or tail of the pancreas, and is oncologically superior to standard retrograde pancreatosplenectomy (SRPS). RAMPS is an operation that actively expands the scope of resection, and achieves a higher R0 resection rate and lymph nodes acquisition through expanded resection. However, previous studies on RAMPS were conducted under 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 world-wide lack of clinical studies to observe the safety and clinical efficacy of robotic RAMPS. Hence, prospective randomized controlled trials (RCTs) comparing robotic RAMPS and SRPS are required. We begin an RCT to compare short-term surgical and oncological outcomes of robotic RAMPS and SRPS in patients undergoing distal pancreatectomy.MethodsThis is a randomized, single-center clinical trial. All participants are adult patients with primary pancreatic cancer, who are undergoing RAMPS or SRPS. The primary endpoints are R0 rate (resection margins are classified by a margin to tumor distance ≥ 1 mm). The secondary endpoints are the number of harvested lymph nodes, perioperative complications and perioperative indicators (duration of surgery, blood loss, blood transfusion volume, costs).DiscussionWe are undertaking a prospective RCT to evaluate the surgical and oncological outcomes of robotic RAMPS. This procedure may become a standard approach to robotic pancreatosplenectomy.Trial registrationChinese Clinical Trial Registry: ChiCTR1900020833, Registered on 20 January 2019.
Highlights
Background and rationale {6a} Early diagnosis of pancreatic cancer is difficult, and the patient’s prognosis is extremely poor, with a 5-year survival rate of about 5% only [1]
The positive rate of the peritoneal resection margin is high after standard retrograde pancreatosplenectomy (SRPS), which is an important cause of tumor metastasis and recurrence
By analyzing the perioperative data from the first 100 cases of robotic pancreaticoduodenectomy performed by a single surgeon in our center, we found that the surgeon's learning cure was completed after performing 40 such operations
Summary
Background and rationale {6a} Early diagnosis of pancreatic cancer is difficult, and the patient’s prognosis is extremely poor, with a 5-year survival rate of about 5% only [1]. Complete surgical resection is the only possible cure for pancreatic cancer, and microscopically margin-negative (R0) resection is the most important factor affecting postoperative survival in these patients [2,3,4]. The positive rate of the peritoneal resection margin is high after SRPS, which is an important cause of tumor metastasis and recurrence. With progress in the concept of tumor treatment, surgical methods in the treatment of cancer in the pancreatic body and tail have improved. Data from meta-analysis suggest that robotic radical antegrade modular pancreatosplenectomy (RAMPS) is a safe and effective procedure for treating adenocarcinoma in the body or tail of the pancreas, and is oncologically superior to standard retrograde pancreatosplenectomy (SRPS). We begin an RCT to compare short-term surgical and oncological outcomes of robotic RAMPS and SRPS in patients undergoing distal pancreatectomy
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