Evaluation of robotic versus open partial pancreatoduodenectomy—study protocol for a randomised controlled pilot trial (EUROPA, DRKS00020407)

Background Partial pancreatoduodenectomy (PD) is the indicated surgical procedure for a wide range of benign and malignant diseases of the pancreatic head and distal bile duct and offers the only potential cure for pancreatic head cancer. The current gold standard, open PD (OPD) performed via laparotomy, is associated with morbidity in around 40% of cases, even at specialised centres. Robotic PD (RPD) might offer a viable alternative to OPD and has been shown to be feasible. Encouraging perioperative results have been reported for RPD in a number of small, non-randomised studies. However, since those studies showed a considerable risk of bias, a thorough comparison of RPD with OPD is warranted. Methods The EUROPA (EvalUation of RObotic partial PAncreatoduodenectomy) trial is designed as a randomised controlled unblinded exploratory surgical trial with two parallel study groups. A total of 80 patients scheduled for elective PD will be randomised after giving written informed consent. Patients with borderline or non-resectable carcinoma of the pancreatic head as defined by the National Comprehensive Cancer Network guidelines, distant metastases or an American Society of Anaesthesiologists (ASA) score > III will be excluded. The experimental intervention, RPD, will be compared with the control intervention, OPD. An intraoperative dropout of approximately eight patients per group is expected because they may receive another type of surgical procedure than planned. Overall, 64 patients need to be analysed. The primary endpoint of the trial is overall postoperative morbidity within 90 days after index operation, measured using the Comprehensive Complication Index (CCI). The secondary endpoints include the feasibility of recruitment and assessment of clinical, oncological and safety parameters and quality of life and cost-effectiveness. Discussion The EUROPA trial is the first randomised controlled trial comparing RPD with OPD. Differences in postoperative morbidity will be evaluated to design a future multicentre confirmatory efficacy trial. Trial registration German Clinical Trial Register DRKS00020407. Registered on 9 March 2020

A Redo of Duct-To-Mucosa Pancreaticojejunostomy for Recurrent Acute Pancreatitis Due to Intra-Pancreatic Lithiasis and Anastomotic Stricture: Is This a Reasonable Strategy?

Few studies have examined the postoperative long-term complications after partial pancreatoduodenectomy and there are mainly focused in the presence of biliary strictures. The occurrence of intra-pancreatic lithiasis secondary to the presence of late stenosis of the duct-to-mucosa pancreaticojejunostomy is an extremely rare condition. We observed that the late occurrence of a pancreaticojejunostomy stricture could be a potential cause for acute pancreatitis in long-term survivors following partial pancreatoduodenectomy. The importance of this report is to emphasize that the strategy of a redo of this difficult anastomosis is a very challenging abdominal operation but provides excellent early and long-term results