Objective: The aim of this study was to develop a classification system for pancreas-associated risk factors in pancreatoduodenectomy (PD). Summary Background Data: Postoperative pancreatic fistula (POPF) is the most relevant PD-associated complication. A simple standardized surgical reporting system based on pancreas-associated risk factors is lacking. Methods: A systematic literature search was conducted to identify studies investigating clinically relevant (CR) POPF (CR-POPF) and pancreas-associated risk factors after PD. A meta-analysis of CR-POPF rate for texture of the pancreas (soft vs not-soft) and main pancreatic duct (MPD) diameter was performed using the Mantel-Haenszel method. Based on the results, the International Study Group of Pancreatic Surgery (ISGPS) proposes the following classification: A, not-soft (hard) texture and MPD >3 mm; B, not-soft (hard) texture and MPD ≤3 mm; C, soft texture and MPD >3 mm; D, soft texture and MPD ≤3 mm. The classification was evaluated in a multi-institutional, international cohort. Results: Of the 2917 articles identified, 108 studies were included in the analyses. Soft pancreatic texture was significantly associated with the development of CR-POPF [odds ratio (OR) 4.24, 95% confidence interval (CI) 3.67-4.89, P < 0.01) following PD. Similarly, MPD diameter ≤3 mm significantly increased CR-POPF risk compared with >3 mm diameter MPDs (OR 3.66, 95% CI 2.62–5.12, P < 0.01). The proposed 4-stage system was confirmed in an independent cohort of 5533 patients with CR-POPF rates of 3.5%, 6.2%, 16.6%, and 23.2% for type A-D, respectively (P < 0.001). Conclusion: For future pancreatic surgical outcomes studies, the ISGPS recommends reporting these risk factors according to the proposed classification system for better comparability of results.

IntroductionIn recent years, minimally invasive distal pancreatectomy (MIDP) has been used with increasing frequency to accelerate patient recovery. Distal pancreatectomy has an overall morbidity rate of 30%–40%. The known advantages of minimally invasive techniques must be rigorously compared with those of open surgery before they can be completely implemented into clinical practice.Methods and analysisDISPACT-2 is a multicentre randomised controlled trial comparing minimally invasive (conventional laparoscopic or robotic assisted) with open distal pancreatic resection in patients undergoing elective surgery for benign as well as malign diseases of the pancreatic body and tail. After screening for eligibility and obtaining informed consent, a total of 294 adult patients will be preoperatively randomised in a 1:1 ratio. The primary hypothesis is that MIDP is non-inferior to open distal pancreatectomy in terms of postoperative mortality and morbidity expressed as the Comprehensive Complication Index (CCI) within 3 months after index operation, with a non-inferiority margin of 7.5 CCI points. Secondary endpoints include pancreas-specific complications, oncological safety and patient reported outcomes. Follow-up for each individual patient will be 2 years.Ethics and disseminationThe DISPACT-2 trial has been approved by the Ethics Committee of the medical faculty of Heidelberg University (S-693/2017). Results of the primary endpoint will be available in 2024 and will be published at national and international meetings. Full results will be made available in an open access, peer-reviewed journal. The website www.dispact.de contains up-to-date information regarding the trial.Trial registration numberDRKS00014011

IntroductionPartial 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 analysisAll 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 disseminationPARIS 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 numberDRKS00017184.