The effect of Braun enteroenterostomy on the postoperative outcome after pyloruspreserving pancreaticoduodenectomy - A randomized controlled multicentric phase III trial (RECOPS)

• Applicant: Professor Dr. Daniel Reim
• Subject Area: General and Visceral Surgery
• Term: since 2020
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 416055422

Pancreatic head resection is the only therapeutic modality for the curative treatment of malignant tumors. Pancreatic head resections are also performed for benign diseases, particularly in the context of chronic pancreatitis, to control the disease. A specific and particularly serious complication of this operation is the formation of a so-called pancreatic fistula. This occurs in 20-30% of cases and increases postoperative mortality by up to 20%. Therefore, a reduction in the fistula rate is directly associated with an improvement in postoperative mortality. The aim of the RECOPS study is to reduce the fistula rate through the technically simple creation of an additional so-called Braun anastomosis. Patients are randomised into an intervention or control group at the end of the operation. Postoperatively, the pancreatic fistula rate is monitored and recorded within 30 days. Secondary endpoints in the same period are the rate of gastric emptying disorders, the overall complication rate, the postoperative haemorrhage rate, mortality, incidence of reinterventions and reoperations, length of hospital stay, quality of life, readmission rate and so-called patient reported otcomes. A total of 606 patients in 18 centres will be included in the study. A reduction in the post-operative fistula rate would not only lead to a considerable reduction in costs due to the lower overall complication rate, but also to an improvement in patient quality of life and a reduction in surgery-related mortality. An interim analysis of the first 50% of patients included showed that the study cannot/must not be terminated prematurely and that the entire planned cohort will be recruited. At the time of the follow-up application, 500 patients had already been randomised.

• DFG Programme: Clinical Trials
• Co-Investigators: Professor Dr. Ihsan Ekin Demir; Professor Dr. Helmut Friess; Dr. Stephan Schorn