| Background and ObjectivePancreaticoduodenectomy(PD)is the preferred curative treatment for malignant and non-malignant neoplasms of the pancreatic head and periampullary region.With the development of surgical technique and perioperative management,mortality after PD has been reduced to rates below 5% in referral centers,but the incidence of morbidity is still as high as 20%-60%.The most hazardous complication is the development of a post-operative pancreatic fistula(POPF),with incidence up to 20%-25%.The occurrence of POPF leads to risk of postpancreatectomy haemorrhage(PPH),delayed gastric emptying(DGE)and Intra-abdominal infection(IAI)with prolonged hospitalization,raised the cost and increased morbidity and increased mortality.In addition,the occurrence of POPF may also delay the time of adjuvant therapy and reduce the overall survival of patients with malignant tumors.This will put enormous pressure on social medical resources.The International Study Group on Pancreatic Surgery(ISGPS)defined and further refinement the diagnosis and classification of POPF in 2005 and 2016,this aroused scholars’ interest in the prediction,prevention and management of POPF,which resulted in significant reduction in the incidence of POPF after PD.However,relative to the low incidence of pancreatic and periampullary tumors and the high risk of POPF,the control of POPF is still not satisfactory.Along with research going deep,researchers have a more clear understanding of the causes and risk factors of POPF.So far,the risk factors of POPF can be summarized into three aspects: the patient characteristics,intrinsic features of the pancreas and the iatrogenic injury.In addition,various centers proposed different pancreatic fistula prediction models or scoring systems,but the universality of these models has not been proved,and the practical application and clinical guidance have not reached the expected results.The current prediction of POPF is mainly based on the patient characteristics and the intrinsic features of the pancreas,and there is no doubt about the independent risk of POPF occurrence.However,with the innovation of pancreatic surgery techniques and the development of the concept of injury control,the influence of intraoperative injury on the occurrence of POPF has gradually emerged,and the risk has a tendency to exceed the patient characteristics and intrinsic features of the pancreas.At present,some international centers have begun to directly or indirectly explore the influence of intraoperative injury on postoperative complications of pancreas,but no consensus has been reached.Based on the above considerations,there is no clinical study in China with a large sample size to evaluate the influence of intraoperative injury on the occurrence of POPF after PD surgery.The purpose of this study is to understand the degree of correlation between intraoperative injury and POPF,explore quantifying indexes of intraoperative injury,and establish a novel POPF prediction model,so as to improve the accuracy of POPF prediction after PD,and provide guidance and reference for the subsequent clinical practice and the proposal of related injury control concepts.MethodsBetween January 2016 and December 2020,patients who underwent PD were retrospectively enrolled into the testing cohort.Patient characteristics,perioperative clinical variables,and postoperative blood biochemistry data were included in analyses to identify proxies for intraoperative iatrogenic injury.A nomogram was constructed based on significant factors and evaluated using a calibration curve.Patients underwent PD from January 2019 to December 2020 were randomly selected for validation cohort.ResultsPart Ⅰ: A total of 596 patients were included in the study cohort based on the database.Univariate analysis identified the following risk factors for POPF after PD:Body Mass Index(BMI),pancreatic texture,main pancreatic duct diameter(MPD diameter),intraoperative blood transfusion,pathology type,the level of drain fluid amylase on Postoperative day one(DFA on POD1),the level of lactate on Postoperative day one(Lac on POD1)and the level of white blood cell level on postoperative day one.Multivariate logistic regression analysis revealed that MPD diameter,DFA on Day1 and Lac on Day1 were independent predictors of POPF after PD.Part Ⅱ: According to the results of Part I,level of DFA on POD1 was divided into three groups by two cut-off values(<325 U/L;≥325,<3109,and ≥3109 U/L),calculated using the minimum P-value approach,and we determined that 2.0 mmol/L was the optimal cut-off value of lactate on POD1 using the same approach.A novel nomogram for predicting POPF was constructed according to the variable screened.The C-index value was 0.867 in the design cohort and 0.916 in the internal validation cohort.ConclusionPOPF can be accurately predicted during surgery with our model using pancreatic duct diameter,POD1 Lac levels,and POD1 drain amylase.The diameter of the main pancreatic duct is a response to the intrinsic features of the pancreas.The level of drain fluid amylase on postoperative day one and the level of lactate on postoperative day one after PD can reflect the condition of anastomosis and the degree of intraoperative injury,respectively.The novel prediction model can more effectively identify patients who can safely be eligible for accelerated recovery and guide the determination of individualized postoperative treatment plan. |
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