Protocol of a prospective study investigating the association of PAncreatic parenchymal RISk factors with postoperative pancreatic fistula after partial pancreaticoduodenectomy (PARIS trial)

INTRODUCTION: Partial pancreatoduodenectomy (PD) is the treatment of choice for many malignant and benign diseases of the pancreatic head. Postoperative complication rates of up to 40% are regularly reported. One of the most common and potentially life-threatening complication is the postoperative pancreatic fistula (POPF). Parenchymal risk factors like main pancreatic duct diameter or texture of the pancreatic gland have already been identified in retrospective studies. The aim of this study is to evaluate the diagnostic value of parenchymal risk factors on POPF in a prospective manner. METHODS AND ANALYSIS: All patients scheduled for elective PD at the Department of General, Visceral and Transplantation Surgery of the University of Heidelberg will be screened for eligibility. As diagnostic factors, diameter and texture of the pancreatic gland as well as radiological and histopathological features will be recorded. Furthermore, the new four class risk classification system by the International Study Group of Pancreatic Surgery (ISGPS) will be recorded. The postoperative course will be monitored prospectively. The primary endpoint will be the association of the main pancreatic duct size and the texture of the pancreatic gland on POPF according to the updated ISGPS definition. The diagnostic value of the above-mentioned factors for POPF will be evaluated in a univariable and multivariable analysis. ETHICS AND DISSEMINATION: PARIS is a monocentric, prospective, diagnostic study to evaluate the association of parenchymal risk factors and the development of POPF approved by the Ethics Committee of the medical faculty of Heidelberg University (S-344/2019). Results will be available in 2022 and will be published at national and international meetings. With this knowledge, the intraoperative and perioperative decision-making process could be eased and improve the individual outcome of patient. TRIAL REGISTRATION NUMBER: DRKS00017184.