The Influence of Intraoperative Blood Loss on Fistula Development Following Pancreatoduodenectomy.

OBJECTIVE: To investigate the role of intraoperative estimated blood loss (EBL) on development of clinically relevant postoperative pancreatic fistula (CR-POPF) after pancreatoduodenectomy (PD). BACKGROUND: Minimizing EBL has been shown to decrease transfusions and provide better perioperative outcomes in PD. EBL is also felt to be influential on CR-POPF development. METHODS: This study consists of 5534 PDs from a 17-institution collaborative (2003-2018). EBL was progressively categorized (≤150mL; 151-400mL; 401-1,000 mL; > 1,000 mL). Impact of additive EBL was assessed using 20 3- factor fistula risk score (FRS) scenarios reflective of endogenous CR-POPF risk. RESULTS: CR-POPF developed in 13.6% of patients (N = 753) and median EBL was 400 mL (interquartile range 250-600 mL). CR-POPF and Grade C POPF were associated with elevated EBL (median 350 vs 400 mL, P = 0.002; 372 vs 500 mL, P < 0.001, respectively). Progressive EBL cohorts displayed incremental CR-POPF rates (8.5%, 13.4%, 15.2%, 16.9%; P < 0.001). EBL >400mL was associated with increased CR-POPF occurrence in 13/20 endogenous risk scenarios. Moreover, 8 of 10 scenarios predicated on a soft gland demonstrated increased CR-POPF incidence. Hypothetical projections demonstrate significant reductions in CR-POPF can be obtained with 1-, 2-, and 3-point decreases in FRS points attributed to EBL risk (12.2%, 17.4%, and 20.0%; P < 0.001). This is especially pronounced in high-risk (FRS7-10) patients, who demonstrate up to a 31% reduction (P < 0.001). Surgeons in the lowest-quartile of median EBL demonstrated CR-POPF rates less than half those in the upper-quartile (7.9% vs 18.8%; P < 0.001). CONCLUSION: EBL independently contributes significant biological risk to CR-POPF. Substantial reductions in CR-POPF occurrence are projected and obtainable by minimizing EBL. Decreased individual surgeon EBL is associated with improvements in CR-POPF.

The Fistula Risk Score Catalog: Toward Precision Medicine for Pancreatic Fistula After Pancreatoduodenectomy.

OBJECTIVE: This study aims to present a full spectrum of individual patient presentations of pancreatic fistula risk, and to define the utility of mitigation strategies amongst some of the most prevalent, and vulnerable scenarios surgeons encounter. BACKGROUND: The FRS has been utilized to identify technical strategies associated with reduced CR-POPF incidence across various risk strata. However, risk-stratification using the FRS has never been investigated with greater granularity. By deriving all possible combinations of FRS elements, individualized risk assessment could be utilized for precision medicine purposes. METHODS: FRS profiles and outcomes of 5533 PDs were accrued from 17 international institutions (2003-2019). The FRS was used to derive 80 unique combinations of patient "scenarios." Risk-matched analyses were conducted using a Bonferroni adjustment to identify scenarios with increased vulnerability for CR-POPF occurrence. Subsequently, these scenarios were analyzed using multivariable regression to explore optimal mitigation approaches. RESULTS: The overall CR-POPF rate was 13.6%. All 80 possible scenarios were encountered, with the most frequent being scenario #1 (8.1%) - the only negligible-risk scenario (CR-POPF rate = 0.7%). The moderate-risk zone had the most scenarios (50), patients (N = 3246), CR-POPFs (65.2%), and greatest non-zero discrepancy in CR-POPF rates between scenarios (18-fold). In the risk-matched analysis, 2 scenarios (#59 and 60) displayed increased vulnerability for CR-POPF relative to the moderate-risk zone (both P < 0.001). Multivariable analysis revealed factors associated with CR-POPF in these scenarios: pancreaticogastrostomy reconstruction [odds ratio (OR) 4.67], omission of drain placement (OR 5.51), and prophylactic octreotide (OR 3.09). When comparing the utilization of best practice strategies to patients who did not have these conjointly utilized, there was a significant decrease in CR-POPF (10.7% vs 35.5%, P < 0.001; OR 0.20, 95% confidence interval 0.12-0.33). CONCLUSION: Through this data, a comprehensive fistula risk catalog has been created and the most clinically-impactful scenarios have been discerned. Focusing on individual scenarios provides a practical way to approach precision medicine, allowing for more directed and efficient management of CR-POPF.

Validation of the Orlando Protocol for endoscopic management of pancreatic fluid collections in the era of lumen-apposing metal stents.

OBJECTIVES: Although lumen-apposing metal stents (LAMS) are being increasingly used in lieu of plastic stents, the clinical approach to endoscopic management of pancreatic fluid collections (PFCs) is poorly standardized. We compared outcomes of approaches over two time intervals, initially using plastic stents and later integrating LAMS. METHODS: This was a retrospective, observational, before-after study of prospectively collected data on consecutive patients with symptomatic PFCs managed over two time periods. In the initial period (January 2010-January 2015) endoscopic treatment was undertaken with plastic stents and in the later period (February 2015-August 2020) by integration of LAMS with selective use of plastic stents. The treatment strategy in both periods were tailored to size, extent, type of PFC and stepwise response to intervention. The main outcome was treatment success, defined as resolution of PFC and presenting symptoms at 6-month follow-up. RESULTS: A total of 160 patients were treated with plastic stents and 227 patients were treated using an integrated LAMS approach. Treatment success was significantly higher for the integrated approach compared to using only plastic stents (95.6 vs. 89.4%; P = 0.018), which was confirmed to be predictive of treatment success on multivariable logistic regression analysis (odds ratio 2.7, 95% confidence interval 1.1-6.4; P = 0.028). CONCLUSIONS: A structured approach integrating LAMS with selective use of plastic stents improved treatment success in patients with PFCs compared to an approach using only plastic stents.

Risk Factors and Mitigation Strategies for Pancreatic Fistula After Distal Pancreatectomy: Analysis of 2026 Resections From the International, Multi-institutional Distal Pancreatectomy Study Group.

OBJECTIVE: To identify a clinical fistula risk score following distal pancreatectomy. BACKGROUND: Clinically relevant pancreatic fistula (CR-POPF) following distal pancreatectomy (DP) is a dominant contributor to procedural morbidity, yet risk factors attributable to CR-POPF and effective practices to reduce its occurrence remain elusive. METHODS: This multinational, retrospective study of 2026 DPs involved 52 surgeons at 10 institutions (2001-2016). CR-POPFs were defined by 2016 International Study Group criteria, and risk models generated using stepwise logistic regression analysis were evaluated by c-statistic. Mitigation strategies were assessed by regression modeling while controlling for identified risk factors and treating institution. RESULTS: CR-POPF occurred following 306 (15.1%) DPs. Risk factors independently associated with CR-POPF included: age (<60 yrs: OR 1.42, 95% CI 1.05-1.82), obesity (OR 1.54, 95% CI 1.19-2.12), hypoalbuminenia (OR 1.63, 95% CI 1.06-2.51), the absence of epidural anesthesia (OR 1.59, 95% CI 1.17-2.16), neuroendocrine or nonmalignant pathology (OR 1.56, 95% CI 1.18-2.06), concomitant splenectomy (OR 1.99, 95% CI 1.25-3.17), and vascular resection (OR 2.29, 95% CI 1.25-3.17). After adjusting for inherent risk between cases by multivariable regression, the following were not independently associated with CR-POPF: method of transection, suture ligation of the pancreatic duct, staple size, the use of staple line reinforcement, tissue patches, biologic sealants, or prophylactic octreotide. Intraoperative drainage was associated with a greater fistula rate (OR 2.09, 95% CI 1.51-3.78) but reduced fistula severity (P < 0.001). CONCLUSIONS: From this large analysis of pancreatic fistula following DP, CR-POPF occurrence cannot be reliably predicted. Opportunities for developing a risk score model are limited for performing risk-adjusted analyses of mitigation strategies and surgeon performance.

A prospective, multi-institution assessment of irreversible electroporation for treatment of locally advanced pancreatic adenocarcinoma: initial outcomes from the AHPBA pancreatic registry.

BACKGROUND: The optimal treatment and management of locally advanced pancreatic cancer (LAPC) remains unclear and controversial. This study aimed to report the initial outcomes of the AHPBA Registry and evaluate the reproducibility of existing evidence that the addition of Irreversible Electroporation (IRE), a nonthermal ablative treatment, confers survival benefits beyond standard therapeutic options for patients with LAPC. METHODS: From December 2015 to October 2017, patients with LAPC were treated with open-technique IRE following the AHPBA Registry Protocols. Patient demographics, long-term outcomes, and adverse events were recorded. Survival analyses were performed using Kaplan-Meier (KM) curves for overall survival (OS), progression free survival (PFS) and time to progression (TTP). RESULTS: A total of 152 patients underwent successful IRE. Morbidity and mortality were 18% and 2% respectively, with 19 (13%) patients experiencing severe adverse events. Nine (6%) patients presented with local recurrence. Median TTP, PFS, and OS from diagnosis were 27.3 months, 22.8 months, and 30.7 months respectively. CONCLUSION: The combination of IRE with established multiagent therapy is safe and demonstrates encouraging survival among patients with LAPC. IRE is associated with a low rate of serious adverse events and has been optimized for more widespread adoption through the standardized protocols available through the AHPBA registry.

Impact of Disconnected Pancreatic Duct Syndrome on the Endoscopic Management of Pancreatic Fluid Collections.

OBJECTIVE: To study the effect of disconnected pancreatic duct syndrome (DPDS) on endoscopic management of pancreatic fluid collections (PFCs). BACKGROUND: Data on the impact of DPDS in patients undergoing endoscopic treatment of PFCs are limited. METHODS: Retrospective study of patients undergoing endoscopic drainage of PFCs from 2003 to 2015. If treatment response was suboptimal following initial endoscopic or endoscopic ultrasound-guided transmural drainage, hybrid interventions (endoscopic ultrasound-guided multigate/dual modality technique, endoscopic/percutaneous sinus tract necrosectomy) were performed. Transmural stents were left permanently in situ in DPDS patients from 2008 onwards. Main outcome measures were to evaluate the effect of DPDS on need for hybrid treatment, reinterventions, rescue surgery, length of stay, and overall treatment success. RESULTS: Of 361 patients, 34 (9.4%) were acute collections, 178 (49.3%) pseudocysts, and 149 (41.3%) walled-off necrosis (WON). DPDS was present in 167 (46.3%) patients, absent in 124 (34.3%), unknown in 70 (19.4%), and occurred more frequently in WON compared to other PFCs (68.3% vs 31.7%; P < 0.001). Although there was no difference in treatment success, more patients with DPDS required hybrid treatment (31.1% vs 4.8%, P < 0.001), reinterventions (30% vs 18.5%, P = 0.03), rescue-surgery (13.2% vs 4.8%, P = 0.02), and longer length of stay [median (interquartile range) days, 3 (2-10) vs 2 (1-4), P = 0.003]. PFC recurrence was lower in patients with DPDS with permanent transmural stents (17.4% vs 1.7%, P < 0.001). On multivariate logistic regression, DPDS [odds ratio (OR) 2.99], WON (OR 3.37), PFC size of 100 mm or more (OR 2.66), and multiple PFCs (OR 10.6) were associated with need for hybrid treatment. CONCLUSIONS: DPDS has a significant effect on endoscopic management of PFCs as more patients required hybrid treatment, reinterventions, and rescue surgery for achieving optimal clinical outcomes.

Characterization and Optimal Management of High-risk Pancreatic Anastomoses During Pancreatoduodenectomy.

OBJECTIVE: The aim of this study was to identify the optimal fistula mitigation strategy following pancreaticoduodenectomy. BACKGROUND: The utility of technical strategies to prevent clinically relevant postoperative pancreatic fistula (CR-POPF) following pancreatoduodenectomy (PD) may vary by the circumstances of the anastomosis. The Fistula Risk Score (FRS) identifies a distinct high-risk cohort (FRS 7 to 10) that demonstrates substantially worse clinical outcomes. The value of various fistula mitigation strategies in these particular high-stakes cases has not been previously explored. METHODS: This multinational study included 5323 PDs performed by 62 surgeons at 17 institutions. Mitigation strategies, including both technique related (ie, pancreatogastrostomy reconstruction; dunking; tissue patches) and the use of adjuvant strategies (ie, intraperitoneal drains; anastomotic stents; prophylactic octreotide; tissue sealants), were evaluated using multivariable regression analysis and propensity score matching. RESULTS: A total of 522 (9.8%) PDs met high-risk FRS criteria, with an observed CR-POPF rate of 29.1%. Pancreatogastrostomy, prophylactic octreotide, and omission of externalized stents were each associated with an increased rate of CR-POPF (all P < 0.001). In a multivariable model accounting for patient, surgeon, and institutional characteristics, the use of external stents [odds ratio (OR) 0.45, 95% confidence interval (95% CI) 0.25-0.81] and the omission of prophylactic octreotide (OR 0.49, 95% CI 0.30-0.78) were independently associated with decreased CR-POPF occurrence. In the propensity score matched cohort, an "optimal" mitigation strategy (ie, externalized stent and no prophylactic octreotide) was associated with a reduced rate of CR-POPF (13.2% vs 33.5%, P < 0.001). CONCLUSIONS: The scenarios identified by the high-risk FRS zone represent challenging anastomoses associated with markedly elevated rates of fistula. Externalized stents and omission of prophylactic octreotide, in the setting of intraperitoneal drainage and pancreaticojejunostomy reconstruction, provides optimal outcomes.

Incorporation of Procedure-specific Risk Into the ACS-NSQIP Surgical Risk Calculator Improves the Prediction of Morbidity and Mortality After Pancreatoduodenectomy.

OBJECTIVE: This multicenter study sought to evaluate the accuracy of the American College of Surgeons National Surgical Quality Improvement Program's (ACS-NSQIP) surgical risk calculator for predicting outcomes after pancreatoduodenectomy (PD) and to determine whether incorporating other factors improves its predictive capacity. BACKGROUND: The ACS-NSQIP surgical risk calculator has been proposed as a decision-support tool to predict complication risk after various operations. Although it considers 21 preoperative factors, it does not include procedure-specific variables, which have demonstrated a strong predictive capacity for the most common and morbid complication after PD - clinically relevant pancreatic fistula (CR-POPF). The validated Fistula Risk Score (FRS) intraoperatively predicts the occurrence of CR-POPF and serious complications after PD. METHODS: This study of 1480 PDs involved 47 surgeons at 17 high-volume institutions. Patient complication risk was calculated using both the universal calculator and a procedure-specific model that incorporated the FRS and surgeon/institutional factors. The performance of each model was compared using the c-statistic and Brier score. RESULTS: The FRS was significantly associated with 30-day mortality, 90-day mortality, serious complications, and reoperation (all P < 0.0001). The procedure-specific model outperformed the universal calculator for 30-day mortality (c-statistic: 0.79 vs 0.68; Brier score: 0.020 vs 0.021), 90-day mortality, serious complications, and reoperation. Neither surgeon experience nor institutional volume significantly predicted mortality; however, surgeons with a career PD volume >450 were less likely to have serious complications (P < 0.001) or perform reoperations (P < 0.001). CONCLUSIONS: Procedure-specific complication risk influences outcomes after pancreatoduodenectomy; therefore, risk adjustment for performance assessment and comparative research should consider these preoperative and intraoperative factors along with conventional ACS-NSQIP preoperative variables.

Pancreas fistula risk prediction: implications for hospital costs and payments.

BACKGROUND: As payment models evolve, disease-specific risk stratification may impact patient selection and financial outcomes. This study sought to determine whether a validated clinical risk score for post-operative pancreatic fistula (POPF) could predict hospital costs, payments, and profit margins. METHODS: A multi-institutional cohort of 1193 patients undergoing pancreaticoduodenectomy (PD) were matched to an independent hospital where cost, in US$, and payment data existed. An analytic model detailed POPF risk and post-operative sequelae, and their relationship with hospital cost and payment. RESULTS: Per-patient hospital cost for negligible-risk patients was $37,855. Low-, moderate-, and high- risk patients had incrementally higher hospital costs of $38,125 ($270; 0.7% above negligible-risk), $41,128 ($3273; +8.6%), and $41,983 ($3858; +10.9%), respectively. Similarly, hospital payment for negligible-risk patients was $42,685/patient, with incrementally higher payments for low-risk ($43,265; +1.4%), moderate-risk ($45,439; +6.5%) and high-risk ($46,564; +9.1%) patients. The lowest 30-day readmission rates - with highest net profit - were found for negligible/low-risk patients (10.5%/11.1%), respectively, compared with readmission rates of moderate/high-risk patients (15%/15.7%). CONCLUSION: Financial outcomes following PD can be predicted using the FRS. Such prediction may help hospitals and payers plan for resource allocation and payment matched to patient risk, while providing a benchmark for quality improvement initiatives.

Risk-adjusted Outcomes of Clinically Relevant Pancreatic Fistula Following Pancreatoduodenectomy: A Model for Performance Evaluation.

OBJECTIVE: To evaluate surgical performance in pancreatoduodenectomy using clinically relevant postoperative pancreatic fistula (CR-POPF) occurrence as a quality indicator. BACKGROUND: Accurate assessment of surgeon and institutional performance requires (1) standardized definitions for the outcome of interest and (2) a comprehensive risk-adjustment process to control for differences in patient risk. METHODS: This multinational, retrospective study of 4301 pancreatoduodenectomies involved 55 surgeons at 15 institutions. Risk for CR-POPF was assessed using the previously validated Fistula Risk Score, and pancreatic fistulas were stratified by International Study Group criteria. CR-POPF variability was evaluated and hierarchical regression analysis assessed individual surgeon and institutional performance. RESULTS: There was considerable variability in both CR-POPF risk and occurrence. Factors increasing the risk for CR-POPF development included increasing Fistula Risk Score (odds ratio 1.49 per point, P < 0.00001) and octreotide (odds ratio 3.30, P < 0.00001). When adjusting for risk, performance outliers were identified at the surgeon and institutional levels. Of the top 10 surgeons (≥15 cases) for nonrisk-adjusted performance, only 6 remained in this high-performing category following risk adjustment. CONCLUSIONS: This analysis of pancreatic fistulas following pancreatoduodenectomy demonstrates considerable variability in both the risk and occurrence of CR-POPF among surgeons and institutions. Disparities in patient risk between providers reinforce the need for comprehensive, risk-adjusted modeling when assessing performance based on procedure-specific complications. Furthermore, beyond inherent patient risk factors, surgical decision-making influences fistula outcomes.

Establishing a quantitative benchmark for morbidity in pancreatoduodenectomy using ACS-NSQIP, the Accordion Severity Grading System, and the Postoperative Morbidity Index.

OBJECTIVE: The study aim was to quantify the burden of complications of pancreatoduodenectomy (PD). BACKGROUND: The Postoperative Morbidity Index (PMI) is a quantitative measure of the average burden of complications of a procedure. It is based on highly validated systems--ACS-NSQIP and the Modified Accordion Severity Grading System. METHODS: Nine centers contributed ACS-NSQIP complication data for 1589 patients undergoing PD from 2005 to 2011. Each complication was assigned a severity weight ranging from 0.11 for the least severe complication to 1.00 for postoperative death, and PMI was derived. Contribution to total burden by each complication grade was used to generate a severity profile ("spectrogram") for PD. Associations with PMI were determined by regression analysis. RESULTS: ACS-NSQIP complications occurred in 528 cases (33.2%). The non-risk-adjusted PMI was 0.115 (SD = 0.023) for all centers and 0.113 (SD = 0.005) for the 7 centers that contributed at least 100 cases. Grade 2 complications were predominant in frequency, and the most common complication was postoperative bleeding/transfusion. Frequency and burden of complications differed markedly. For instance, severe complications (grades 4/5/6) accounted for only about 20% of complications but for more than 40% of the burden of complications. Organ space infection had the highest burden of any complication. The average burden in cases in which a complication actually occurred was 0.346. CONCLUSIONS: This study develops a quantitative non-risk-adjusted benchmark for postoperative morbidity of PD. The method quantifies the burden of types and grades of postoperative complications and should prove useful in identifying areas that require quality improvement.

Equal efficacy of endoscopic and surgical cystogastrostomy for pancreatic pseudocyst drainage in a randomized trial.

BACKGROUND & AIMS: Although surgery is the standard technique for drainage of pancreatic pseudocysts, use of endoscopic methods is increasing. We performed a single-center, open-label, randomized trial to compare endoscopic and surgical cystogastrostomy for pancreatic pseudocyst drainage. METHODS: Patients with pancreatic pseudocysts underwent endoscopic (n = 20) or surgical cystogastrostomy (n = 20). The primary end point was pseudocyst recurrence after a 24-month follow-up period. Secondary end points were treatment success or failure, complications, re-interventions, length of hospital stay, physical and mental health scores, and total costs. RESULTS: At the end of the follow-up period, none of the patients who received endoscopic therapy had a pseudocyst recurrence, compared with 1 patient treated surgically. There were no differences in treatment successes, complications, or re-interventions between the groups. However, the length of hospital stay was shorter for patients who underwent endoscopic cystogastrostomy (median, 2 days, vs 6 days in the surgery group; P < .001). Although there were no differences in physical component scores and mental health component scores (MCS) between groups at baseline on the Medical Outcomes Study 36-Item Short-Form General Survey questionnaire, longitudinal analysis showed significantly better physical component scores (P = .019) and mental health component scores (P = .025) for the endoscopy treatment group. The total mean cost was lower for patients managed by endoscopy than surgery ($7011 vs $15,052; P = .003). CONCLUSIONS: In a randomized trial comparing endoscopic and surgical cystogastrostomy for pancreatic pseudocyst drainage, none of the patients in the endoscopy group had pseudocyst recurrence during the follow-up period, therefore there is no evidence that surgical cystogastrostomy is superior. However, endoscopic treatment was associated with shorter hospital stays, better physical and mental health of patients, and lower cost. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00826501.

Pancreatic adenocarcinoma: a pilot study of quantitative perfusion and diffusion-weighted breath-hold magnetic resonance imaging.

PURPOSE: To confirm the feasibility of breath-hold DCE-MRI and DWI at 3T to obtain the intra-abdominal quantitative physiologic parameters, K(trans), k ep, and ADC, in patients with untreated pancreatic ductal adenocarcinomas. METHODS: Diffusion-weighted single-shot echo-planar imaging (DW-SS-EPI) and dynamic contrast-enhanced (DCE) MRI were used for 16 patients with newly diagnosed biopsy-proven pancreatic ductal adenocarcinomas. K(trans), k ep, and apparent diffusion coefficient (ADC) values of pancreatic tumors, non-tumor adjacent pancreatic parenchyma (NAP), liver metastases, and normal liver tissues were quantitated and statistically compared. RESULTS: Fourteen patients were able to adequately hold their breath for DCE-MRI, and 15 patients for DW-SS-EPI. Four patients had liver metastases within the 6 cm of Z axis coverage centered on the pancreatic primary tumors. K(trans) values (10(-3) min(-1)) of primary pancreatic tumors, NAP, liver metastases, and normal liver tissues were 7.3 ± 4.2 (mean ± SD), 25.8 ± 14.9, 8.1 ± 5.9, and 45.1 ± 15.6, respectively, k ep values (10(-2) min(-1)) were 3.0 ± 0.9, 7.4 ± 3.1, 5.2 ± 2.0, and 12.1 ± 2.8, respectively, and ADC values (10(-3) mm(2)/s) were 1.3 ± 0.2, 1.6 ± 0.3, 1.1 ± 0.1, and 1.3 ± 0.1, respectively. K(trans), k ep, and ADC values of primary pancreatic tumors were significantly lower than those of NAP (p < 0.05), while K(trans) and k ep values of liver metastases were significantly lower than those of normal liver tissues (p < 0.05). CONCLUSIONS: 3T breath-hold quantitative physiologic MRI is a feasible technique that can be applied to a majority of patients with pancreatic adenocarcinomas.

Prophylactic octreotide for pancreatoduodenectomy: more harm than good?

BACKGROUND: Most accrued evidence regarding prophylactic octreotide for a pancreatoduodenectomy (PD) predates the advent of the International Study Group of Pancreatic Fistula (ISGPF) classification system for a post-operative pancreatic fistula (POPF), and its efficacy in the setting of high POPF risk is unknown. The Fistula Risk Score (FRS) predicts the risk and impact of a clinically relevant (CR)-POPF and can be useful in assessing the impact of octreotide in scenarios of risk. METHODS: From 2001-2013, 1018 PDs were performed at four institutions, with octreotide administered at the surgeon's discretion. The FRS was used to analyse the occurrence and burden of POPF across various risk scenarios. RESULTS: Overall, 391 patients (38.4%) received octreotide. A CR-POPF occurred more often when octreotide was used (21.0% versus 7.0%; P < 0.001), especially when there was advanced FRS risk. Octreotide administration also correlated with an increased hospital stay (mean: 13 versus 11 days; P < 0.001). Regression analysis, controlling for FRS risk, demonstrated that octreotide increases the risk for CR-POPF development. CONCLUSION: This multi-institutional study, using ISGPF criteria, evaluates POPF development across the entire risk spectrum. Octreotide appears to confer no benefit in preventing a CR-POPF, and may even potentiate CR-POPF development in the presence of risk factors. This analysis suggests octreotide should not be utilized as a POPF mitigation strategy.

Defining the post-operative morbidity index for distal pancreatectomy.

BACKGROUND: Accurate assessment of complications is critical in analysing surgical outcomes. The post-operative morbidity index (PMI), derived from the Modified Accordion Severity Grading System and American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP), is a quantitative measure of post-operative morbidity. This study utilizes PMI to establish the complication burden for a distal pancreatectomy (DP). METHODS: From 2005-2011, nine centres contributed ACS-NSQIP complication data for 655 DPs. Each complication was assigned an Accordion severity weight ranging from 0.11 for grade 1 to 1.00 for grade 6 (death). The PMI is the sum of complication severity weights divided by the total number of patients. RESULTS: ACS-NSQIP complications occurred in 177 patients (27.0%). The non risk-adjusted PMI for DP is 0.087. Bleeding/Transfusion and Organ Space Infection were the most common complications. Frequency and burden differed across Accordion grades. While grade 4-6 complications represented only 15.4% of complication occurrences, they accounted for 30.4% of the burden. Subgroup analysis demonstrates that the PMI did not vary based on laparoscopic versus open approach or the performance of a splenectomy. DISCUSSION: This study uses two validated systems to quantitatively establish the morbidity of a DP. The PMI allows estimation of both the frequency and severity of complications and thus provides a more comprehensive assessment of risk.

Computed tomography attenuation and patient characteristics as predictors of complications after pancreaticoduodenectomy.

OBJECTIVES: Morbidity after pancreaticoduodenectomy (PD) remains high. Computed tomography (CT) of intra-abdominal tissue has not been thoroughly evaluated to establish associations with the occurrence of complications after PD. The current study sought to determine whether differences in non-enhanced visceral attenuation predicted complications after PD. METHODS: Outcomes in patients undergoing PD were analysed according to the Clavien system for classifying complications and the International Study Group on Pancreatic Fistula system for classifying postoperative pancreatic fistula (POPF). Preoperative non-enhanced CT scans were evaluated by a blinded investigator for attenuation of abdominal viscera and fat thickness. Data on pancreatic firmness and pancreatic duct size were collected. Univariate and multivariate analyses were performed. RESULTS: A total of 134 patients underwent PD for malignant and benign disease. Rates of morbidity, mortality and POPF at 90 days were 61%, 4% and 23%, respectively. Patients with a body mass index of > 25 kg/m(2) had higher rates of POPF (P = 0.05) and complications (P < 0.01). In multivariate analysis, patients were more likely to develop any complication as CT attenuation decreased for paraspinus muscle (P < 0.01), spleen (P < 0.03) and liver (P = 0.01) parenchyma. CONCLUSIONS: Postoperative complications after PD remain prevalent. Decreased CT attenuation of abdominal viscera is an independent predictor of morbidity after PD and suggests a high-risk patient physiology for pancreatic resection.

Assessing the impact of a fistula after a pancreaticoduodenectomy using the Post-operative Morbidity Index.

BACKGROUND: The Post-operative Morbidity Index (PMI) is a quantitative utility measure of a complication burden created by severity weighting. The Fistula Risk Score (FRS) is a validated model that predicts whether a patient will develop a post-operative pancreatic fistula (POPF). These novel tools might provide further discrimination of the ISGPF grading system. METHODS: From 2001 to 2012, 1021 pancreaticoduodenectomies were performed at four institutions. POPFs were categorized by ISGPF standards. PMI scores were calculated based on the Modified Accordion Severity Grading System. FRS scores were assigned according to the relative influence of four recognized factors for developing a clinically relevant POPF (CR-POPF). RESULTS: In total, 231 patients (22.6%) developed a POPF, of which 54.1% were CR-POPFs. The PMI differed significantly between the ISGPF grades and patients with no or non-fistulous complications (P < 0.001). 64.9% of POPFs and 84.0% of CR-POPFs contributed the highest Accordion grade to the PMI. Overall, the FRS correlated well with PMI (R(2) = 0.81, P < 0.001). CONCLUSION: These data quantitatively reinforce the ISGPF grades that were developed qualitatively around the concept of clinical severity. CR-POPFs usually reflect the patient's highest Accordion score whereas biochemical POPFs are often superseded. The correlation between FRS and PMI indicates that risk factors for a fistula contribute to overall pancreaticoduodenectomy morbidity.

Stenting versus gastrojejunostomy for management of malignant gastric outlet obstruction: comparison of clinical outcomes and costs.

BACKGROUND: Although endoscopic stenting is increasingly performed, surgical gastrojejunostomy (GJ) is still considered the gold standard for relief of malignant gastric outlet obstruction (GOO). The aim of this study is to compare clinical outcomes and hospital costs between patients undergoing GJ or stenting for management of malignant GOO. METHODS: A retrospective claims analysis of the Medicare (MedPAR) database was conducted to identify all inpatient hospitalizations for GJ or endoscopic stenting for malignant GOO during 2007-2008. The main outcome measure evaluated using the MedPAR database was a comparison of the total length of hospital stay (LOS) and costs associated with both techniques. As MedPAR is a claims database that does not provide outcomes at patient level, a single-institution retrospective study was conducted to compare the rates of technical and treatment success, post-procedure LOS, and delayed complications per patient between the two techniques. RESULTS: The MedPAR claims data evaluated 425 stenting and 339 GJ hospitalizations. Compared with GJ, median LOS (8 vs. 16 days; p < 0.0001) and median cost (US $15,366 vs. US $27,391; p < 0.0001) per claim were both significantly lower for stenting. Stenting was more commonly performed at urban versus rural hospitals (89 % vs. 11 %; p < 0.0001), teaching versus non-teaching hospitals (59 % vs. 41 %, p = 0.0005), and academic institutions (56 % vs. 44 %; p = 0.0157). The institutional patient data analysis included 29 patients who underwent stenting and 75 who underwent surgical GJ. While both modalities were technically successful and relieved gastric outlet obstruction in all cases, compared with surgical GJ, the median post-procedure LOS was significantly lower for enteral stenting (1.5 vs. 10.7 days, p < 0.0001). There was no difference in rates of delayed complications between stenting and surgical GJ (13.8 % vs. 6.7 %; p = 0.26). CONCLUSIONS: While the technical and clinical outcomes of surgical GJ and endoscopic stenting appear comparable, stent placement is less costly and is associated with shorter length of hospital stay. Dissemination of endoscopic stenting beyond teaching, academic hospitals located in urban areas as a treatment for malignant GOO is important given its implications for patient care and resource utilization.

A risk-adjusted analysis of drain use in pancreaticoduodenectomy: Some is good, but more may not be better.

BACKGROUND: Intraperitoneal drain placement decreases morbidity and mortality in patients who develop a clinically relevant postoperative pancreatic fistula (CR-POPF) following pancreaticoduodenectomy (PD). It is unknown whether multiple drains mitigate CR-POPF better than a single drain. We hypothesized that multiple drains decrease the complication burden more than a single drain in cases at greater risk for CR-POPF. METHODS: The Fistula Risk Score (FRS), mitigation strategies (including number of drains placed), and clinical outcomes were obtained from a multi-institutional database of PDs performed from 2003 to 2020. Outcomes were compared between cases utilizing 0, 1, or 2 intraperitoneal drains. Multivariable regression analysis was used to evaluate the optimal drainage approach. RESULTS: A total of 4,292 PDs used 0 (7.3%), 1 (45.2%), or 2 (47.5%) drains with an observed CR-POPF rate of 9.6%, which was higher in intermediate/high FRS zone cases compared with negligible/low FRS zone cases (13% vs 2.4%, P < .001). The number of drains placed also correlated with FRS zone (median of 2 in intermediate/high vs 1 in negligible/low risk cases). In intermediate/high risk cases, the use of 2 drains instead of 1 was not associated with a reduced rate of CR-POPF, average complication burden attributed to a CR-POPF, reoperations, or mortality. Obviation of drains was associated with significant increases in complication burden and mortality - regardless of the FRS zone. CONCLUSION: In intermediate/high risk zone cases, placement of a single drain or multiple drains appears to mitigate the complication burden while use of no drains is associated with inferior outcomes.

Multiple transluminal gateway technique for EUS-guided drainage of symptomatic walled-off pancreatic necrosis.

BACKGROUND: Walled-off pancreatic necrosis often leads to severe clinical deterioration necessitating open debridement or endoscopic necrosectomy. A new EUS-based approach was devised to manage this condition by creating multiple transluminal gateways to facilitate effective drainage of the necrotic contents. OBJECTIVE: To compare treatment outcomes between patients with walled-off pancreatic necrosis managed endoscopically by a multiple transluminal gateway technique (MTGT) or a conventional drainage technique (CDT). DESIGN: Retrospective study. SETTING: Tertiary-care referral center. PATIENTS: This study involved patients with severe acute pancreatitis complicated by walled-off pancreatic necrosis managed endoscopically. INTERVENTION: In MTGT, 2 or 3 transmural tracts were created by using EUS guidance between the necrotic cavity and the GI lumen. While one tract was used to flush normal saline solution via a nasocystic catheter, multiple stents were deployed in others to facilitate drainage of necrotic contents. In the CDT, two stents with a nasocystic catheter were deployed via 1 transmural tract. MAIN OUTCOME MEASUREMENTS: Resolution of symptoms, radiological findings on follow-up CT, and the need for subsequent surgery or endoscopic necrosectomy. RESULTS: Of 60 patients with symptomatic walled-off pancreatic necrosis, 12 (3 women, mean age 55.1 years) were managed by MTGT and 48 (12 women, mean age 55.2 years) by CDT. Treatment was successful in 11 of 12 (91.7%) patients managed by MTGT versus 25 of 48 (52.1%) managed by CDT (P = .01). Although 1 patient in the MTGT cohort required endoscopic necrosectomy, in the CDT cohort, 17 required surgery, 3 underwent endoscopic necrosectomy, and 3 died of multiple-organ failure. Treatment success was more likely for patients treated by MTGT than by CDT (adjusted odds ratio = 9.24; 95% confidence interval, 1.08-79.02; P = .04) when we adjusted for the size of the walled-off pancreatic necrosis and pancreatic duct stent placement. LIMITATIONS: Selective patient population. CONCLUSION: The EUS-guided MTGT is an effective treatment option for the management of symptomatic walled-off pancreatic necrosis because it obviates the need for surgery and endoscopic necrosectomy and its attendant procedure-related morbidity. Prospective studies are required to confirm these preliminary but promising data.