International Study Group Of Pancreatic Surgery Research Articles

Clinical and Financial Validation of the International Study Group for Pancreatic Surgery (ISGPS) Definition of Post-Pancreatectomy Acute Pancreatitis (PPAP): International Multicenter Prospective Study.

To validate the ISGPS definition and grading system of PPAP after pancreatoduodenectomy (PD). In 2022, the International Study Group for Pancreatic Surgery (ISGPS) defined post-pancreatectomy acute pancreatitis (PPAP) and recommended a prospective validation of its diagnostic criteria and grading system. This was a prospective, international, multicenter study including patients undergoing PD at 17 referral pancreatic centers across Europe, Asia, Oceania, and the United States. PPAP diagnosis required the following three parameters: (1) postoperative serum hyperamylasemia /hyperlipasemia (POH) persisting on postoperative days 1 and 2, (2) radiologic alterations consistent with PPAP, and (3) a clinically relevant deterioration in the patient's condition. To validate the grading system, clinical and economic parameters were analyzed across all grades. Among 2902 patients undergoing PD, 7.5% (n=218) developed PPAP (6.3% grade B and 1.2% grade C). POH occurred in 24.1% of patients. Hospital stay was associated with PPAP grades (No POH/PPAP 10 days (IQR 7-17) days, grade B 22 days (IQR 15-34) days, and grade C 43 days (IQR 27-54) days; P<0.001), as well as intensive care unit admission (No POH/PPAP 5.4%, grade B 12.6%, grade C 82.9%; P<0.010), and hospital readmission rates (No POH/PPAP 7.3%, grade B 16.1%, grade C 18.5%; P<0.05). Costs of grade B and C PPAP were 2 and 11 times greater than uncomplicated clinical course, resp. (P<0.001). This first prospective, international validation study of the ISGPS definition and grading system for PPAP highlighted the relevant clinical and financial implications of this condition. These results stress the importance of routine screening for PPAP in patients undergoing PD.

Proposal of a revised 3-tier "2mm" risk classification model for postoperative pancreatic fistula in robotic pancreatoduodenectomy.

The recent International Study Group for Pancreatic Surgery (ISGPS) risk classification for postoperativepancreatic fistula (grade B/C) was developed based on data from open and mixed minimally invasive pancreatoduodenectomy. The ISGPS risk classification model has not been validated specifically for POPF after robotic pancreatoduodenectomy (RPD). We calculated the rate of POPF (ISGPS 2016 definition, grade B/C) by analyzing consecutive patients after RPD by surgeons after their learning curves (80 RPDs per surgeon). The validation of the ISGPS 4-tier and the simplified 3-tier risk classification was conducted using the area under the receiver operating curve (AUC). From 2019 to 2023, 187 patients after RPD were included. Neither the ISGPS 4-tier nor the simplified 3-tier classification model showed robust discrimination (AUC: 0.696 and 0.685, respectively). Moreover, both risk classifications failed to differentiate the rates of POPF and major complications among subgroups. Multivariate analysis suggested that soft pancreatic texture and pancreatic duct ≤ 2mm were independent risk factors for POPF after RPD. After adjusting the duct size's cutoff from 3 to 2mm, the revised 4-tier "2mm" classification model showed no significant difference between risk categories B and C (6.7% vs. 9.4%, P = 0.063). The revised 3-tier "2mm" classification model stratified patients into A (n = 54), B (n = 68), and C (n = 65) groups, with corresponding POPF rates of 0.0%, 8.8%, and 23.1% (P < 0.001), and major complication rates of 5.6, 14.7, and 24.6% (P = 0.014), respectively. Compared to the simplified 3-tier classification model, the revised 3-tier "2mm" classification model showed improved discrimination (AUC: 0.753 vs. 0.685, P = 0.034) and clinical utility. The current ISGPS 4-tier and the simplified 3-tier classification models lacked sufficient discrimination in patients after RPD. We propose a revised 3-tier "2mm" risk classification model for RPD with a robust discrimination, which requires further international validation with prospectively obtained data.

Delayed Gastric Emptying and Other Adverse Outcomes in Patients Undergoing Classic Whipple Versus Pylorus-Sparing Pancreatoduodenectomy.

Background and objective Pancreatoduodenectomy (PD), or the Whipple procedure, has many variants. There is a lack of data in the literature in terms of comparing various types of this procedure. This study aimed to comparethe classic Whipple procedure with the pylorus-sparing Transverso-Longmire technique, focusing on postoperative complications and delayed gastric emptying (DGE). Methodology We conducted a retrospective observational study including 97 adult patients who underwent either the classic Whipple procedure or the pylorus-sparing technique at Hospital Médica Sur from 2016 to 2021. Data on patient demographics, comorbidities, type of surgery, clinical presentation, and postoperative complications were collected. DGE was defined according to the International Study Group of Pancreatic Surgery(ISGPS) criteria. Results Among the 97 patients, 50.5% were men, and the median age of the cohort was 65 years. Almost all patients underwent surgery for malignancy (96.9%). The classic Whipple group had fewer cases of DGE (9.8% vs. 30.6%, p=0.01), shorter hospital stays (7 vs. 11 days, p=0.001), and lower readmission rates (13.1% vs. 33.3%, p=0.017). The pylorus-sparing PD was associated with a lower incidence of bile leak [odds ratio (OR)=0.62, 95% confidence interval (CI): 0.53-0.73]. However, this technique was associated with a higher incidence of DGE (OR=4, 95% CI: 1.34-12.1), overall hospital admission rates (OR=3.3, 95% CI: 1.2-9.2), and admissions that resulted in a surgical event (OR=1.9, 95% CI: 1.21-2.96). DGE was associated with the need for a second surgery (OR=10.5, 95% CI: 2.8-39.5) and hospital readmission (OR=10, 95% CI: 3.1-32.3). Conclusions While the pylorus-sparing technique is associated with reduced bile leaks, it results in a higher incidence of DGE, prolonged hospital stays, and increased readmissions. Clinicians opting for the pylorus-sparing technique should ensure careful patient selection and rigorous postoperative monitoring.

Validation and Optimisation of the ISGPS Risk Classification for Postoperative Pancreatic Fistula after Pancreatoduodenectomy for Periampullary Tumours.

To externally validate the International Study Group of Pancreatic Surgery (ISGPS) classification and test its performance for predicting clinically relevant pancreatic fistula (CRPF) for periampullary tumours (P-amps). The ISGPS is a simple two-factor, four-tier classification of pancreas-related risk for CRPF after a pancreatoduodenectomy (PD). External validation and performance of the classification specific to P-amps are lacking. P-amps have different disease biology, lesser need for neoadjuvant therapy, softer pancreas, and a higher rate of CRPF, underscoring the importance of site-specific prediction. Validation was performed in a cohort of 1422 patients, with CRPF as the primary outcome. Model performance was tested by plotting the receiver operating curve and calibration plots. After analysing the factors predicting CRPF, the model was optimised for P-amps. CRPF rate was 22.2% (315/1422), for P-amps being 25.8%. The ISGPS model performed moderately (AUC=0.632, 95% CI 0.598-0.666, P<0.001), with worse performance for P-amps (AUC=0.605, 95% CI 0.566-0.645, P<0.001). On multivariate analysis, soft pancreas (OR 1.689, 95% CI 1.136-2.512, P=0.010), body mass index ≥23kg/m2 (OR 2.112, 95% CI 1.464-3.046, P<0.001) and pancreatic duct ≤3mm (OR 2.113 95% CI 1.457-3.064, P<0.001), emerged as independent predictors and the model was optimised. The adjusted ISGPS for P-amps showed improved discrimination (AUC=0.672, P<0.001, 95% CI 0.637-0.707), with adequate performance on internal validation. The adjusted ISPGS performs better than the original ISGPS in predicting CRPF for P-amps. Large-scale multicenter data is needed to generate and validate site-specific predictive models.

Prospective Validation of the Pancreatic Fistula Risk Classification by the International Study Group for Pancreatic Surgery (PARIS trial).

The aim of this study was a prospective validation of the recently established ISGPS pancreas classification as a parenchymal risk classification system for pancreatic fistula after pancreatoduodenectomy. Postoperative pancreatic fistula (POPF) is the major driver for complications after partial pancreatoduodenectomy (PD). Recently, the International Study Group for Pancreatic Surgery (ISGPS) published a pancreas classification containing the parameters main pancreatic duct diameter (MPD) and pancreatic texture to help assess the risk of POPF development following pancreatoduodenectomy. From January 2020 to July 2021, 271 patients receiving elective PD were included after informed consent. The postoperative course was documented prospectively up to postoperative day 30. Among the pancreas characteristics, MPD and pancreatic texture were assessed intraoperatively at the pancreatic resection margin and the pancreatic glands were assigned to one of the four pancreas classes according to the ISGPS (A to D). The primary endpoint was POPF according to the updated ISGPS definition. Secondary endpoints comprised other post-PD morbidity and mortality. Of 271 patients, 264 had available data according to the ISGPS pancreas classification. Of those, 78 were assigned to class A (30%), 53 to class B (20%), 50 to class C (19%) and 83 to class D (31%). POPF occurred in 54 of 271 patients (19.9%). The 30-day mortality was 7/271 (2.6%), with 6/7 having developed POPF (86%). POPF rates within the classes A, B, C and D were 9.0%, 11.3%, 20.0% and 37.4%, respectively (P<0.001). In the univariable regression analysis, only patients in pancreas class D demonstrated a significantly higher risk for POPF when compared to class A (OR 6.05, 95%-CI: 2.6-15.9, P<0.001). In the multivariable regression model, patients in class D had a significantly higher risk for POPF compared to class A (OR 3.45, 95%-CI: 1.15-11.3, P=0.032). The model comprised Body Mass Index, surgery duration, microscopic fibrosis and the ISGPS pancreas classification, demonstrating an AUC-value of approximately 0.82 when tested on the PARIS dataset. This prospective trial shows that the ISGPS pancreas classification is valid. Patients in risk class D are prone to POPF independently of other factors. Therefore, all future publications on pancreatic surgery should report the risk class according to the ISGPS pancreas classification to allow for a better comparison of reported cohorts.

Interobserver Variability in the International Study Group for Pancreatic Surgery (ISGPS)-Defined Complications After Pancreatoduodenectomy: An International Cross-Sectional Multicenter Study.

To determine the interobserver variability for complications of pancreatoduodenectomy as defined by the International Study Group for Pancreatic Surgery (ISGPS) and others. Good interobserver variability for the definitions of surgical complications is of major importance in comparing surgical outcomes between and within centers. However, data on interobserver variability for pancreatoduodenectomy-specific complications are lacking. International cross-sectional multicenter study including 52 raters from 13 high-volume pancreatic centers in 8 countries on 3 continents. Per center, 4 experienced raters scored 30 randomly selected patients after pancreatoduodenectomy. In addition, all raters scored 6 standardized case vignettes. This variability and the "within centers" variability were calculated for 2-fold scoring (no complication/grade A vs grade B/C) and 3-fold scoring (no complication/grade A vs grade B vs grade C) of postoperative pancreatic fistula, postpancreatoduodenectomy hemorrhage, chyle leak, bile leak, and delayed gastric emptying. Interobserver variability is presented with Gwet AC-1 measure for agreement. Overall, 390 patients after pancreatoduodenectomy were included. The overall agreement rate for the standardized cases vignettes for 2-fold scoring was 68% (95% CI: 55%-81%, AC1 score: moderate agreement), and for 3-fold scoring 55% (49%-62%, AC1 score: fair agreement). The mean "within centers" agreement for 2-fold scoring was 84% (80%-87%, AC1 score; substantial agreement). The interobserver variability for the ISGPS-defined complications of pancreatoduodenectomy was too high even though the "within centers" agreement was acceptable. Since these findings will decrease the quality and validity of clinical studies, ISGPS has started efforts aimed at reducing the interobserver variability.

Extracellular volume fraction derived from dual-energy CT: a potential predictor for acute pancreatitis after pancreatoduodenectomy.

To investigate the value of extracellular volume (ECV) fraction and fat fraction (FF) derived from dual- energy CT (DECT) for predicting postpancreatectomy acute pancreatitis (PPAP) after pancreatoduodenectomy (PD). This retrospective study included patients who underwent DECT and PD between April 2022 and September 2022. PPAP was determined according to the International Study Group for Pancreatic Surgery (ISGPS) definition. Iodine concentration (IC) and FF of the pancreatic parenchyma were measured on preoperative DECT. The ECV fraction was calculated from iodine map images of the equilibrium phase. The independent predictors for PPAP were assessed by univariate and multivariable logistic regression analysisand receiver operating characteristic (ROC) curve analysis. Sixty-nine patients were retrospectively enrolled (median age, 60 years; interquartile range, 55-70 years; 47 men). Of these, nine patients (13.0%) developed PPAP. These patients had lower portal venous phase IC, equilibrium phase IC, FF, and ECV fraction, and higher pancreatic parenchymal-to-portal venous phase IC ratio and pancreatic parenchymal-to-equilibrium phase IC ratio, compared with patients without PPAP. After multivariable analysis, ECV fraction was independently associated with PPAP (odd ratio [OR], 0.87; 95% confidence interval [CI]: 0.79, 0.96; p < 0.001), with an area under the curve (AUC) of 0.839 (sensitivity 100.0%, specificity 58.3%). A lower ECV fraction is independently associated with the occurrence of PPAP after PD. ECV fraction may serve as a potential predictor for PPAP after PD. DECT-derived ECV fraction of pancreatic parenchyma is a promising biomarker for surgeons to preoperatively identify patients with higher risk for postpancreatectomy acute pancreatitis after PD and offer selective perioperative management. PPAP is a complication of pancreatic surgery, early identification of higher-risk patients allows for risk mitigation. Lower DECT-derived ECV fraction was independently associated with the occurrence of PPAP after PD. DECT aids in preoperative PAPP risk stratification, allowing for appropriate treatment to minimize complications.

Characterization of Pancreatic Fistula after Post-pancreatectomy Acute Pancreatitis.

This study aimed to investigate the clinical significance and risk factors of postoperative pancreatic fistula (POPF) after post-pancreatectomy acute pancreatitis (PPAP) in patients who underwent pancreaticoduodenectomy (PD). PPAP has been recognized as a critical factor in the pathophysiology of POPF after PD. A total of 817 consecutive patients who underwent elective PD between January 2020 and June 2022 were included. PPAP and POPF were defined in accordance with the International Study Group for Pancreatic Surgery (ISGPS) definitions. Multivariate logistic analyses were performed to investigate the risk factors for POPF. Comparisons between PPAP-associated POPF and non-PPAP-associated POPF were made to further characterize this intriguing complication. Overall, 159 (19.5%) patients developed POPF after PD, of which 73 (45.9%) occurred following PPAP, and the remaining 86 (54.1%) had non-PPAP-associated POPF. Patients with PPAP-associated POPF experienced significantly higher morbidity than patients without POPF. Multivariate analyses revealed distinct risk factors for each POPF type. For PPAP-associated POPF, independent risk factors included estimated blood loss >200mL (OR 1.93), MPD ≤3cm (OR 2.88), and soft pancreatic texture (OR 2.01), largely overlapping with FRS (Fistula Risk Score) elements. On the other hand, non-PPAP-associated POPF was associated with age >65 years (OR 1.95), male (OR 2.10), and MPD ≤3cm (OR 2.57). Notably, among patients with PPAP, the incidence of POPF consistently hovered around 50% regardless of the FRS stratification. PPAP-associated POPF presents as a distinct pathophysiology in the development of POPF after PD, potentially opening doors for future prevention strategies targeting the early postoperative period.

Post-pancreatectomy acute pancreatitis after pancreatoduodenectomy: Analysis of a clinically-relevant complication in a single-center retrospective study

Background/Objectives: This study aimed to evaluate the frequency, clinical impact, and risk factors of post-pancreatectomy acute pancreatitis (PPAP) after pancreatoduodenectomy (PD) according to the definition proposed by the International Study Group for Pancreatic Surgery (ISGPS). Methodspatients undergoing PD between 2010 and 2021 were retrospectively analyzed. PPAP was defined according to the ISGPS criteria, including elevated serum amylase for 48 h and concurring pancreatitis alterations on a CT scan. Results272 patients were finally included in the study. PPAP occurred in 40 (14.7 %) patients, and it was significantly related to higher rates of clinically-relevant postoperative pancreatic fistula (CR-POPF) (p < 0.001), post-pancreatectomy hemorrhage (PPH) (p < 0.001) and major complications (Clavien-Dindo ≥ 3a) (p < 0.001). Moreover, PPAP in the absence of CR-POPF (n = 18) was significantly related to longer hospital stay (p < 0.001), PPH (p < 0.001), major complications (Clavien-Dindo≥ 3a, p = 0.001) and higher intensive care unit costs (p = 0.029) compared to patients not developing PPAP. In the univariable and multivariable analysis, the duct size (p = 0.004) and high-risk pathologies (p = 0.004) but not intraoperative bleeding (p = 0.066) represented independent risk factors for PPAP. In the same analysis, patients receiving a bridging therapy with low molecular-weight heparin showed significantly lower rates of PPAP (p = 0.045). ConclusionsPPAP represents a relevant complication after PD. Its risk factors are similar to those for CR-POPF, while anticoagulants could represent a possible prevention strategy.

HPB P30 The role of interventional radiology in managing post-pancreatectomy hemorrhage at a major hepatobiliary centre in the UK

Abstract Background Pancreatoduodenectomy (PD) is a common surgery performed by hepatobiliary surgeons. Mortality is 5% and morbidity is 30-40%. An important cause is post-pancreatectomy hemorrhage (PPH). As per the International Study Group for Pancreatic Surgery (ISGPS), grade C PPH represents most cases of hemorrhage post-PD and always requires intervention. They tend to be arterial in origin and CT angiogram of the celiac axis and superior mesenteric artery is recommended. Historically, the treatment for PPH was a re-look laparotomy. With the development of interventional radiology (IR) techniques, morbidity and mortality has improved. Transcatheter arterial embolization is a well-established treatment for bleeding. Methods Southampton General Hospital is a tertiary centre for hepatobiliary surgery and interventional radiology. All patients who underwent PD between 2019 and 2023 were checked for complications. Patients who developed PPH were selected and their PACs was checked for what investigation they underwent. The findings of the angiogram and intervention done were recorded. Morbidity and mortality data was also collected including whether patients returned to theatre. Results Seven male patients aged 57 to 75 had type C PPH. Symptom onset including melaena and haematemesis was between 24 hours to 38 days. The time to CT from the request was between one to six hours. One patient was bleeding from the gastroduodenal artery stump. The other six patients had no obvious bleeding point identified. Of the seven patients, five had bleeding points identified on angiograms done by IR and underwent embolization. One patient returned-to-theatre for a re-look laparotomy. Two of seven patients died within one year of PPH. One had repeated PPH and had embolization multiple times. Conclusions Harnoss et al., (2014) reported that the rate of PPH post PD was 5.9%. The use of angiography with embolization is being adopted worldwide for arterial bleeding in hemodynamically stable patients due to its minimal invasiveness. Even if embolization fails, angiography can help identify the bleeding point and guide surgical management. The reported immediate mortality rate from PPH is 30% and at our centre it was 0% in our small sample size.

Treatment strategies to prevent or mitigate the outcome of post-pancreatectomy hemorrhage (PPH): a review of randomized trials.

Post-pancreatectomy hemorrhage (PPH) is a leading cause for surgical mortality after pancreatic surgery. Several strategies for the prevention and management of PPH have been studied in randomized controlled trials (RCTs) but a systematic review is lacking. We systematically reviewed RCTs regarding the impact of treatment strategies on the incidence and outcome of PPH. Eligible RCTs reporting on impact of treatment on the rate of PPH were identified through a systematic literature search using the Evidence Map of Pancreatic Surgery (2012-2022). Methodological quality was assessed using the Cochrane Risk of Bias 2 (RoB-2) tool for RCTs. Various definitions of PPH were accepted and outcome reported separately for the International Study Group for Pancreatic Surgery (ISGPS) definition. Overall, 99 RCTs fulfilled the eligibility criteria with a pooled 6.1% rate of PPH (range 1%-32%). The pooled rate of PPH defined as ISGPS grade B/C was 8.1% (range 0-24.9%). Five RCTs reported five strategies that significantly reduced the rate of PPH. Three concerned surgical technique: pancreatic anastomosis with small jejunal incision, falciform ligament wrap around the gastroduodenal artery stump, and pancreaticojejunostomy (vs pancreaticogastrostomy). Two concerned perioperative management: perioperative pasireotide administration, and algorithm-based postoperative patient management. No single RCT specifically focused on the treatment of patients with PPH. This systematic review of RCTs identified five strategies which reduce the rate of PPH; three concerning intraoperative surgical technique and two concerning peri-operative patient management. Future studies should focus on the treatment of patients with PPH as RCTs are currently lacking.

Early vs late drain removal after pancreatic resection-a systematic review and meta-analysis.

Reducing clinically relevant post-operative pancreatic fistula (CR-POPF) incidence after pancreatic resections has been a topic of great academic interest. Optimizing post-operative drain management is a potential strategy in reducing this major complication. Studies involving pancreatic resections, including both pancreaticoduodenectomy (PD) and distal pancreatic resections (DP), with intra-operative drain placement were screened. Early drain removal was defined as removal before or on the 3rd post-operative day (POD) while late drain removal was defined as after the 3rd POD. The primary outcome was CR-POPF, International Study Group of Pancreatic Surgery (ISGPS) Grade B and above. Secondary outcomes were all complications, severe complications, post-operative haemorrhage, intra-abdominal infections, delayed gastric emptying, reoperation, length of stay, readmission, and mortality. Nine studies met the inclusion criteria and were included for analysis. The studies had a total of 8574 patients, comprising 1946 in the early removal group and 6628 in the late removal group. Early drain removal was associated with a significantly lower risk of CR-POPF (OR: 0.24, p < 0.01). Significant reduction in risk of post-operative haemorrhage (OR: 0.55, p < 0.01), intra-abdominal infection (OR: 0.35, p < 0.01), re-admission (OR: 0.63, p < 0.01), re-operation (OR: 0.70, p = 0.03), presence of any complications (OR: 0.46, p < 0.01), and reduced length of stay (SMD: -0.75, p < 0.01) in the early removal group was also observed. Early drain removal is associated with significant reductions in incidence of CR-POPF and other post-operative complications. Further prospective randomised trials in this area are recommended to validate these findings.

Clinical validation of the international study group of pancreatic surgery (ISGPS) definition for post-pancreatectomy acute pancreatitis

BackgroundThe diagnosis of postoperative or post-pancreatectomy acute pancreatitis (PPAP) is controversial. In 2021, the International Study Group of Pancreatic Surgery (ISGPS) published the first unifying definition and grading system for PPAP. This study sought to validate recent consensus criteria, using a cohort of patients undergoing pancreaticoduodenectomy (PD) in a high-volume pancreaticobiliary specialty unit. MethodsAll consecutive patients undergoing PD at a tertiary referral centre between January 2016 and December 2021 were retrospectively reviewed. Patients with serum amylase recorded within 48h from surgery were included for analysis. Postoperative data were extracted and evaluated against the ISGPS criteria, including the presence of postoperative hyperamylasaemia, radiologic features consistent with acute pancreatitis, and clinical deterioration. ResultsA total of 82 patients were evaluated. The overall incidence of PPAP was 32% (26/82) in this cohort, of which 3/26 demonstrated postoperative hyperamylasaemia and 23/26 had clinically relevant PPAP (Grade B or C) when correlated radiologic and clinical criteria. ConclusionsThis study is among the first to apply the recently published consensus criteria for PPAP diagnosis and grading to clinical data. While the results support their utility in establishing PPAP as a distinct post-pancreatectomy complication, there remains a need for future large-scale validation studies.

Acute pancreatitis after pancreatoduodenectomy: clinical outcomes and predictive factors analysis according to the International Study Group of Pancreatic Surgery definition

BackgroundPost-pancreatectomy acute pancreatitis (PPAP) is an increasingly described complication after pancreatic resection. No uniform definition criteria were present in the literature until the recent proposal of the International Study Group of Pancreatic Surgery (ISGPS). Aim of this study is to evaluate the clinical significance of the novel ISGPS definition of PPAP. MethodsPatients who underwent pancreatoduodenectomy (PD) between 2006 and 2022 were enrolled. PPAP was defined and graded according to the ISGPS criteria. ResultsAmong 520 PDs, 120 (23%)patients developed post-operative hyperamylasemia (POH), while PPAP occurred in 63(12.1%) cases. PPAP occurrence related to a higher rate of more severe complications (48–76.1%vs118–25.8%; p < 0.0001), delayed gastric emptying (DGE) (27–42.9%vd114–24.9%; p = 0.003) and post-operative pancreatic fistula (POPF) (57–90.5%vs186–40.8%; p < 0.0001). When stratified for PPAP severity, grade B and C patients more frequently developed major complications (p < 0.0001), POPF (p < 0.0001), DGE (p = 0.02) and post-operative hemorrhage (p < 0.0001) as compared to POH. At the multivariable analysis, soft pancreatic texture (p = 0.01)and a Wirsung diameter ≤3 mm (p = 0.01) were recognized as prognostic factors for PPAP onset, while a pancreatic duct ≤3 mm was the only feature significantly influencing a more severe course of PPAP (p = 0.01). ConclusionThe ISGPS classification is confirmed as a valuable method for a uniform definition and clinical course evaluation. Further studies in a prospective manner are still needed for a further confirmation.

Appraising pancreatic fistula in pancreas transplantation: A comprehensive complication index based analysis of postoperative outcomes and predictors of graft survival

BackgroundA definition of pancreatic fistula specifically addressing pancreas transplantation (PT) is lacking. This study sought to characterize pancreatic fistula in this setting and to define its clinical relevance on the postoperative course and long-term graft survival (GS). MethodsConsecutive simultaneous pancreas and kidney transplantations were analysed. The global postoperative course was assessed through the comprehensive complication index (CCI). PF was defined according to the original International Study Group for Pancreatic Surgery (ISGPS) definition. Predictors of poor postoperative course and GS were explored. ResultsSeventy-eight patients were analysed. Surgical morbidity was 48.7%, with severe complications occurring in 39.7%. Ninety-day mortality was 2.6%. PF occurred in 56.6% of patients, although its average clinical burden was low and did not correlate with either early or long-term outcomes. Peri-graft fluid collections, postoperative day (POD) 1 drain fluid amylase (DFA) ≥ 2200 U/L, and POD 5 DFA/serum amylase ratio ≥7.0 independently correlated with poor postoperative course. Perigraft fluid collections were associated with reduced GS. ConclusionConventionally defined pancreatic fistula is frequent following PT, although its clinical impact is negligible. To define clinically relevant PF, novel cut-offs for DFA might be pondered in a future series, while perigraft fluid collections should be strongly considered.

Prophylactic abdominal drainage or no drainage after distal pancreatectomy (PANDORINA): a study protocol of a binational multicenter randomized controlled trial

BackgroundProphylactic abdominal drainage is current standard practice after distal pancreatectomy (DP), with the aim to divert pancreatic fluid in case of a postoperative pancreatic fistula (POPF) aimed to prevent further complications as bleeding. Whereas POPF after pancreatoduodenectomy, by definition, involves infection due to anastomotic dehiscence, a POPF after DP is essentially sterile since the bowel is not opened and no anastomoses are created. Routine drainage after DP could potentially be omitted and this could even be beneficial because of the hypothetical prevention of drain-induced infections (Fisher, 2018). Abdominal drainage, moreover, should only be performed if it provides additional safety or comfort to the patient. In clinical practice, drains cause clear discomfort. One multicenter randomized controlled trial confirmed the safety of omitting abdominal drainage but did not stratify patients according to their risk of POPF and did not describe a standardized strategy for pancreatic transection. Therefore, a large pragmatic multicenter randomized controlled trial is required, with prespecified POPF risk groups and a homogeneous method of stump closure.The objective of the PANDORINA trial is to evaluate the non-inferiority of omitting routine intra-abdominal drainage after DP on postoperative morbidity (Clavien-Dindo score ≥ 3), and, secondarily, POPF grade B/C.Methods/designBinational multicenter randomized controlled non-inferiority trial, stratifying patients to high and low risk for POPF grade B/C and incorporating a standardized strategy for pancreatic transection. Two groups of 141 patients (282 in total) undergoing elective DP (either open or minimally invasive, with or without splenectomy). Primary outcome is postoperative rate of morbidity (Clavien-Dindo score ≥ 3), and the most relevant secondary outcome is grade B/C POPF. Other secondary outcomes include surgical reintervention, percutaneous catheter drainage, endoscopic catheter drainage, abdominal collections (not requiring drainage), wound infection, delayed gastric emptying, postpancreatectomy hemorrhage as defined by the international study group for pancreatic surgery (ISGPS) (Wente et al., 2007), length of stay (LOS), readmission within 90 days, in-hospital mortality, and 90-day mortality.DiscussionPANDORINA is the first binational, multicenter, randomized controlled non-inferiority trial with the primary objective to evaluate the hypothesis that omitting prophylactic abdominal drainage after DP does not worsen the risk of postoperative severe complications (Wente et al., 2007; Bassi et al., 2017). Most of the published studies on drain placement after pancreatectomy focus on both pancreatoduodenectomy and DP, but these two entities present are associated with different complications and therefore deserve separate evaluation (McMillan et al., 2016; Pratt et al., 2006). The PANDORINA trial is innovative since it takes the preoperative risk on POPF into account based on the D-FRS and it warrants homogenous stump closing by using the same graded compression technique and same stapling device (de Pastena et al., 2022; Asbun and Stauffer, 2011).

Postpancreatectomy Acute Pancreatitis After Pancreaticoduodenectomy: A Distinct Clinical Entity.

This study aimed to characterize postpancreatectomy acute pancreatitis (PPAP) after pancreaticoduodenectomy (PD) in a high-volume center. The International Study Group for Pancreatic Surgery (ISGPS) has recently proposed a new definition and grading scale of PPAP, but specific studies are lacking. Patients who underwent PD from 2020 to 2021 were retrospectively reviewed. PPAP was defined based on the International Study Group for Pancreatic Surgery definition: sustained elevation of serum amylase levels for least the first 48 hours postoperatively and radiologic alterations consistent with PPAP. Among a total of 716 patients who were finally analyzed, PPAP occurred in 152 (21.2%) patients. Patients with PPAP were associated with significantly higher incidences of postoperative pancreatic fistula (POPF) (40.8% vs 11.7%, P <0.001), major complications (13.8% vs 6.6%, P =0.004), and biliary leak (11.8% vs 4.6%, P =0.001). Among them, 8 patients developed grade C PPAP leading to organ failure, reoperation, or death. Patients developing PPAP alone also demonstrated a statistically significantly increased rate of major complications than those without PPAP or POPF. In contrast, no differences were found in postoperative outcomes in patients with POPF in terms of whether they were associated with PPAP. PPAP is a distinct complication after PD with distinctive clinical outcomes. A part of PPAP presents as an inflammatory process in the early postoperative period but sometimes could lead to necrotizing pancreatitis or other severe clinical scenarios, and another part of PPAP would lead to anastomotic failure that accounts for a great proportion of POPF occurrence.

Portal Vein Resection in Pancreatic Cancer Surgery: Risk of Thrombosis and Radicality Determine Survival.

To evaluate the outcomes of pancreatic cancer [pancreatic ductal adenocarcinoma (PDAC)] surgery with concomitant portal vein resection (PVR), focusing on the PVR type according to the International Study Group of Pancreatic Surgery (ISGPS). Surgery offers the only chance for cure in PDAC. PVR is often performed for borderline or locally advanced tumors. Consecutive patients with PDAC operated between January 2006 and January 2018 were included. Clinicopathologic characteristics and outcomes were analyzed and tested for survival prediction. Of 2265 PDAC resections, 1571 (69.4%) were standard resections and 694 (30.6%) were resections with PVR, including 149 (21.5%) tangential resections with venorrhaphy (ISGPS type 1), 21 (3.0%) resections with patch reconstruction (type 2), 491 (70.7%) end-to-end anastomoses (type 3), and 33 (4.8%) resections with graft interposition (type 4). The 90-day mortality rate was 2.6% after standard resection and 6.3% after resection with PVR ( P <0.0001). Postoperative portal vein thrombosis and pancreas-specific surgical complications most frequently occurred after PVR with graft interposition (21.2% and 48.5%, respectively). In multivariable analysis, age 70 years and above, ASA stages 3/4, increased preoperative serum carbohydrate antigen 19-9, neoadjuvant treatment, total pancreatectomy, PVR, higher UICC stage, and R+ resections were significant negative prognostic factors for overall survival. Radical R0 (>1mm) resection resulted in 23.3 months of median survival. This is the largest single-center, comparative cohort study of PVR in PDAC surgery, showing that postoperative morbidity correlates with the reconstruction type. When radical resection is achieved, thrombosis risk is outweighed by beneficial overall survival times of nearly 2 years.

Delayed gastric emptying after classical Whipple or pylorus-preserving pancreatoduodenectomy: a randomized clinical trial (QUANUPAD)

PurposePylorus-preserving pancreatoduodenectomy (PPPD) has been the gold standard for pancreatic head lesion resection for several years. Some studies have noted that it involves more delayed gastric emptying (DGE) than classical Whipple (i.e., pancreatoduodenectomy with antrectomy). Our working hypothesis was that the classical Whipple has a lower incidence of DGE. We aimed to compare the incidence of DGE among pancreatoduodenectomy techniques.MethodsThis pragmatic, randomized, open-label, single-center clinical trial involved patients who underwent classical Whipple (study group) or PPPD (control group). Gastric emptying was clinically evaluated using scintigraphy. DGE was defined according to the International Study Group of Pancreatic Surgery (ISGPS) criteria. The secondary endpoints were postoperative morbidity, length of hospital stay, anthropometric measurements, and nutritional status.ResultsA total of 84 patients were randomized (42 per group). DGE incidence was 50% (20/40, 95% confidence interval (95% CI): 35–65%) in the study group and 62% (24/39, 95% CI: 46–75%) in the control group (p = 0.260). No differences were observed between both groups regarding postoperative morbidity or length of hospital stay. Anthropometric measurements at 6 months post-surgery: triceps fold measurements were 12 mm and 16 mm (p = 0.021). At 5 weeks post-surgery, triceps fold measurements were 13 mm and 16 mm (p = 0.020) and upper arm circumferences were 26 cm and 28 cm (p = 0.030). No significant differences were observed in nutritional status.ConclusionDGE incidence and severity did not differ between classical Whipple and PPPD. Some anthropometric measurements may indicate a better recovery with PPPD.Trial registrationClinicalTrials.gov Identifier: NCT03984734.

A systematic review of post-pancreatectomy haemorrhage management stratified according to ISGPS grading.

Morbidity and mortality from post-pancreatectomy haemorrhage (PPH) remains high. The International Study Group of Pancreatic Surgery (ISGPS) published guidelines to standardise definitions of PPH severity, management and reporting. This study aimed to i) identify the number of studies reporting PPH using ISGPS guidelines (Grade A, B or C) and ii) describe treatment modality success by grade. A systematic literature review was performed, identifying studies reporting PPH by ISGPS Grade and their subsequent management. Of 62 studies reporting on PPH management, 17 (27.4%) stratified by ISGPS guidelines and included 608 incidences of PPH: 48 Grade A, 274 Grade B (62 early, 166 late, 46 unspecified) and 286 Grade C. 96% of Grade A PPH were treated conservatively. Of 62 early Grade B, 54.8% were managed conservatively and 37.1% surgically. Late Grade B were managed non-operatively in 25.3% (42/166), with successful endoscopy in 90.9% (10/11) and angiography in 90.3% (28/31). In Grade C, endoscopic treatment was successful in 64.4% (29/45) and angiography in 90.8% (108/119). Surgical intervention was required in 43.5% early Grade B, 7.8% late Grade B and 33.2% Grade C. PPH grading is underreported and despite guidelines, inconsistencies remain when using definitions and reporting of outcomes.