Tara S. Kent

A prospectively validated clinical risk score accurately predicts pancreatic fistula after pancreatoduodenectomy.

BACKGROUND Clinically relevant postoperative pancreatic fistulas (CR-POPF) are serious inherent risks of pancreatic resection. Preoperative CR-POPF risk assessment is currently inadequate and rarely disqualifies patients who need resection. The best evaluation of risk occurs intraoperatively, and should guide fistula prevention and response measures thereafter. We sought to develop a risk prediction tool for CR-POPF that features intraoperative assessment and reveals associated clinical and economic significance. STUDY DESIGN Based on International Study Group of Pancreatic Fistula classification, recognized risk factors for CR-POPF (small duct, soft pancreas, high-risk pathology, excessive blood loss) were evaluated during pancreaticoduodenectomy. An optimal risk score range model, selected from 3 different constructs, was first derived (n = 233) and then validated prospectively (n = 212). Clinical and economic outcomes were evaluated across 4 ranges of scores (negligible risk, 0 points; low risk, 1 to 2; intermediate risk, 3 to 6; high risk, 7 to 10). RESULTS Clinically relevant postoperative pancreatic fistulas occurred in 13% of patients. The incidence was greatest with excessive blood loss. Duct size <5 mm was associated with increased fistula rates that rose with even smaller ducts. These factors, together with soft pancreatic parenchyma and certain disease pathologies, afforded a highly predictive 10-point Fistula Risk Score. Risk scores strongly correlated with fistula development (p < 0.001). Notably, patients with scores of 0 points never developed a CR-POPF, while fistulas occurred in all patients with scores of 9 or 10. Other clinical and economic outcomes segregated by risk profile across the 4 risk strata. CONCLUSIONS A simple 10-point Fistula Risk Score derived during pancreaticoduodenectomy accurately predicts subsequent CR-POPF. It can be readily learned and broadly deployed. This prediction tool can help surgeons anticipate, identify, and manage this ominous complication from the outset.

Induction gemcitabine and stereotactic body radiotherapy for locally advanced nonmetastatic pancreas cancer.

PURPOSE Stereotactic body radiotherapy (SBRT) has been used successfully to treat patients with locally advanced pancreas cancer. However, many patients develop metastatic disease soon after diagnosis and may receive little benefit from such therapy. We therefore retrospectively analyzed a planned strategy of initial chemotherapy with restaging and then treatment for those patients with no evidence of metastatic progression with SBRT. METHODS AND MATERIALS Forty-seven patients received gemcitabine (1,000 mg/m(2) per week for 3 weeks then 1 week off) until tolerance, at least six cycles, or progression. Patients without metastases after two cycles were treated with SBRT (tolerance-based dose of 24-36 Gy in 3 fractions) between the third and fourth cycles without interrupting the chemotherapy cycles. RESULTS Eight of the 47 patients (17%) were found to have metastatic disease after two cycles of gemcitabine; the remaining 39 patients received SBRT. The median follow-up for survivors was 21 months (range, 6-36 months). The median overall survival for all patients who received SBRT was 20 months, and the median progression-free survival was 15 months. The local control rate was 85% (33 of 39 patients); and 54% of patients (21 of 39) developed metastases. Late Grade III toxicities such as GI bleeding and obstruction were observed in 9% (3/39) of patients. CONCLUSION For patients with locally advanced pancreas cancer, this strategy uses local therapy for those who are most likely to benefit from it and spares those patients with early metastatic progression from treatment. SBRT delivers such local therapy safely with minimal interruption to systemic chemotherapy, thereby potentially improving the outcome in these patients.

Readmission after Major Pancreatic Resection: A Necessary Evil?

BACKGROUND Hospital readmission is under increased scrutiny as a quality metric for surgical performance, yet its relevance after elective, high-acuity operations is poorly understood. We sought to define the clinical nature and economic impact of readmission after major pancreatic resection. STUDY DESIGN From 2001 to 2009, 578 pancreatic resections followed standardized perioperative care. Clinical and economic outcomes were evaluated and predictors of readmission were identified by regression analysis. RESULTS One hundred and eleven (19%) patients required readmission within 30 days (median 8 days post discharge), with only 12 more readmitted between 31 and 90 days. Twenty-three (21%) patients were readmitted multiple times. Reasons for readmission were procedure-specific complications (48%), general postoperative complications/infections (18.0%), failure to thrive (12%), or medical problems (9%). An additional 14% were readmitted solely for diagnostic evaluation of symptoms without cause. Neither preoperative demographics/acuity nor intraoperative factors influenced readmission. Instead, readmission was predicted by any (odds ratio = 2.24) or major (odds ratio = 2.19) complications, and clinically relevant (odds ratio = 5.05) or latent (odds ratio = 4.04) pancreatic fistula. Patient survival was negatively, but not significantly, associated with readmissions. Overall hospital stay and costs were markedly affected by readmission, as readmitted patients cost an average of

Split-bolus spectral multidetector CT of the pancreas: assessment of radiation dose and tumor conspicuity.

16,000 more. CONCLUSIONS In this practice-based analysis, readmissions after pancreatic resection were frequent, early, costly, and largely related to procedure-specific complications. As initial hospital stay continues to decline in high-acuity surgery, readmissions might be required for optimal management of complications, which often manifest later in the recovery course. Clinical pathway deviations predict potential readmissions, and might prompt adjustments in management and disposition of patients at risk for returning to the hospital.

The burden of infection for elective pancreatic resections.

PURPOSE To assess tumor conspicuity and radiation dose with a new multidetector computed tomography (CT) protocol for pancreatic imaging that combines spectral CT and split-bolus injection. MATERIALS AND METHODS This study was approved by the institutional review board and compliant with HIPAA. The requirement for informed consent was waived. One hundred sixty-three consecutive patients referred for possible pancreatic mass underwent CT with either a standard or split-bolus spectral CT protocol depending on scanner availability. Split-bolus spectral CT (CT unit with spectral imaging) combines pancreatic and portal venous phases in a single scan: 70 seconds before CT, 100 mL of contrast material is injected for the portal venous phase followed approximately 35 seconds later by injection of 40 mL of contrast material to boost the pancreatic phase. Bolus tracking after the second bolus initiates scanning 15 seconds after aorta enhancement reaches 280 HU. Images were reconstructed at 60 and 77 keV. The standard protocol (64-detector row unit) included unenhanced and pancreatic and portal venous phase imaging, with a single contrast material injection timed with bolus tracking 15 seconds after aortic enhancement of 300 HU for the pancreatic phase and 32 seconds later for the portal venous phase. Tumor conspicuity (difference in attenuation between tumor and pancreatic parenchyma) and contrast-to-noise ratio (CNR) were determined. Attenuation of aorta, main portal vein, and liver were measured. Patient size and per-examination radiation dose were recorded. The heteroscedastic t test, Fisher exact test, and Mann-Whitney test were used for statistical analysis. RESULTS There were no significant differences in age, weight, and body mass index between patients in the standard CT (46 of 80 patients had lesions) and split-bolus spectral CT (39 of 83 patients had lesions) groups; however, there were significantly more women in the split-bolus group (P = .02). Tumor conspicuity and CNR were higher with the 60-keV split-bolus protocol (89.1 HU ± 56.6 and 8.8 ± 6.2, respectively) than with the pancreatic or portal venous phase of the standard protocol (43.5 HU ± 28.4 and 4.5 ± 3.0, and 51.5 HU ± 30.3 and 5.6 ± 4.0, respectively; P < .01 for all comparisons). Dose-length product was 1112 mGy · cm ± 437 with the standard protocol and 633 mGy · cm ± 105 with the split-bolus protocol (P < .001). CONCLUSION Split-bolus spectral multidetector CT resulted in vascular, liver, and pancreatic attenuation and tumor conspicuity equal to or greater than that with multiphase CT, with a 43% reduction in radiation dose.

Prophylactic octreotide for pancreatoduodenectomy: more harm than good?

BACKGROUND Infection control is potentially a critical quality indicator but remains incompletely understood, especially in high-acuity gastrointestinal surgery. Our objective was to evaluate the incidence and impact of infections after elective pancreatectomy at the practice level. METHODS All pancreatectomies performed by three pancreatic surgical specialists over an 8-year period (2001-2009) followed standardized perioperative care, including timely antibiotic administration. Infections were defined according to National Surgery Quality Improvement Program criteria, while complication severity was based on Clavien grade. Clinical and economic outcomes were evaluated and predictors of infection identified by regression analysis. RESULTS Of 550 major pancreatic resections, 288 (53%) had some complication, of which 167 (31%) were infectious. Rates of infection differed by type of resection (proximal pancreatectomy > others; P = .029) but not by presence of malignancy. Major infections (Clavien 3-5; n = 62), occurred in 11% of cases. Infection was not the primary cause of death in any patient. Infection was associated with increases in hospital stay, operative times, transfusions, blood loss, intensive care unit use, and readmission (34% vs 12%). Types of infection were as follows: wound infection (14%), infected pancreatic fistula (9%), urinary tract infection (7%), pneumonia (6%), and sepsis (2%). The use of total parenteral nutrition (odds ratio [OR], 7.3), coronary artery disease (OR, 2.1), and perioperative hypotension (OR, 1.6) predicted any infection. Total costs for cases with infection increased grade-for-grade across the Clavien scale, with infection accounting for 38% of the overall cost differential. CONCLUSION Infectious complications occurred frequently, compromising numerous outcomes and increasing costs markedly. These data provide a foundation for understanding the baseline consequences of infection in high-acuity gastrointestinal surgery and offer opportunities for process evaluation and initiatives in infection control at the practice level.

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

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 surgeons 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.

The pancreaticojejunal anastomotic stent: Friend or foe?

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.

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

BACKGROUND The efficacy of pancreaticojejunal (P-J) anastomotic stents in preventing clinically relevant postoperative pancreatic fistulas (CR-POPF) after pancreatic resection is poorly understood. We sought to compare the outcomes of stented and nonstented patients in light of recognized risk-factors for the development of CR-POPF and to determine whether outcomes differed once there was a change in practice where use of stents was abandoned. METHODS A total of 444 patients underwent proximal pancreatic resection with P-J reconstruction from 2001 to 2011. At the surgeons discretion, a PJ stent (5- or 8-Fr Silastic tube) was placed in 59 patients (13.3%; 46 internal, 13 external). Demographics, comorbidities, and adjusted outcomes were evaluated between groups of nonstented (n = 385) and stented patients; these outcomes included a subgroup analysis of internally and externally stented patients. Risk factors for CR-POPF (International Study Group on Pancreatic Fistula grade B/C) development have been previously defined as soft gland, small duct size, high-risk pathology, or excessive blood loss (>1,000 mL). Outcomes were interpreted in reference to the risk factor profile (the number of absolute risk factors present; 0-4), and to the fistula risk score, a prospectively validated score which accurately predicts the risk and impact of pancreatic fistula based on these variables. RESULTS Preoperative demographics of age, sex, body mass index, American Society of Anesthesiologists class, and physiologic and operative severity score for the enumeration of mortality and morbidity (ie, POSSUM) score were equivalent between cohorts. The CR-POPF risk-factor profile and fistula risk score were greater in stented patients (P < .01). When compared with nonstented patients, stented patients actually had greater rates of CR-POPF (29% vs 11%), major complications (29% vs 14%), greater mean duration of stay (13.7 days vs 9.6 days), and total costs (

Comparing the burden of pancreatic fistulas after pancreatoduodenectomy and distal pancreatectomy

33,594 vs