Implementation of prospective, surgeon-driven, risk-based pathway for pancreatoduodenectomy results in improved clinical outcomes and first year cost savings of $1 million.

BACKGROUND: Morbidity and costs after pancreatoduodenectomy remain increased, driven by postoperative pancreatic fistula (POPF). A risk-based pathway for pancreatoduodenectomy (RBP-PD) was implemented and the clinical and cost outcomes compared with that of our historic practice. METHODS: Prospective clinical and cost outcomes for our RBP-PD cohort treated from September 2014 to September 2015 were compared with a previously published cohort of pancreatoduodenectomies from January 2007 to February 2014. RESULTS: A total of 128 RBP-PD cases were compared with 808 historic controls. Apart from less blood loss, there were no significant clinical differences between the 2 groups. Overall POPF rate did not change. Average duration of stay decreased to 10 days from 12 (P < .001) despite similar readmission rates. Postsurgical interventional radiology procedures decreased to 18.0% from 26.4% (P = .048). Utilization of and duration of stay in monitored care decreased to 23.4% from 35.6% (P < .01) and to 1 day from 3 (P < .01). On multivariable analysis RBP-PD was independently associated with decreased odds of higher postoperative pancreatic fistula grade, monitored care, and prolonged duration of stay. Inpatient cost of care decreased $6,387 per patient (-11.1%, P = .016), and total 30-day costs decreased $8,565 per patient (-13.7%, P = .01), representing a total 30-day cost savings of $1.1 million. CONCLUSION: RBP-PD significantly improved patient outcomes, decreased costs of care, and likely has applicability for surgical care beyond pancreatoduodenectomy.

Postoperative pancreatic fistula-impact on outcome, hospital cost and effects of centralization.

BACKGROUND: One of the most serious complications after pancreaticoduodenectomy (PD) is postoperative pancreatic fistula (POPF). This study investigated the incidence of POPF before and after centralization of pancreatic surgery in Southern Sweden and its impact on outcome and health care costs. METHODS: The local registry comprising all pancreatic resections at Skåne University Hospital, Lund, Sweden, was searched for PDs from 2005 to 2015. The patients were analysed in three groups: low-volume, high-volume and after introduction of an enhanced recovery program. Only the clinically relevant POPF grades B and C (CR-POPF) were investigated. RESULTS: 322 consecutive patients were identified. The annual operation volume increased almost threefold and the postoperative length of stay and total hospital cost decreased concurrently. The incidence of CR-POPF did not decrease over time. The group with CR-POPF had more complications and prolonged length of stay. The cost was 1.5 times higher for patients with CR-POPF and the cost did not decline despite the increase of hospital volume. CONCLUSION: Centralization of pancreatic surgery did not decrease the rate of CR-POPF nor its subsequent impact on LOS and costs. Further efforts must be made to reduce the incidence of CR-POPF.

Selective Perioperative Administration of Pasireotide is More Cost-Effective Than Routine Administration for Pancreatic Fistula Prophylaxis.

BACKGROUND: In a randomized trial, pasireotide significantly decreased the incidence and severity of postoperative pancreatic fistula (POPF). Subsequent analyses concluded that its routine use is cost-effective. We hypothesized that selective administration of the drug to patients at high risk for POPF would be more cost-effective. STUDY DESIGN: Consecutive patients who did not receive pasireotide and underwent pancreatoduodenectomy (PD) or distal pancreatectomy (DP) between July 2011 and January 2014 were distributed into groups based on their risk of POPF using a multivariate recursive partitioning regression tree analysis (RPA) of preoperative clinical factors. The costs of treating hypothetical patients in each risk group were then computed based upon actual institutional hospital costs and previously published relative risk values associated with pasireotide. RESULTS: Among 315 patients who underwent pancreatectomy, grade B/C POPF occurred in 64 (20%). RPA allocated patients who underwent PD into four groups with a risk for grade B/C POPF of 0, 10, 29, or 60% (P < 0.001) on the basis of diagnosis, pancreatic duct diameter, and body mass index. Patients who underwent DP were allocated to three groups with a grade B/C POPF risk of 14, 26, or 44% (P = 0.05) on the basis of pancreatic duct diameter alone. Although the routine administration of pasireotide to all 315 patients would have theoretically saved $30,892 over standard care, restriction of pasireotide to only patients at high risk for POPF would have led to a cost savings of $831,916. CONCLUSION: Preoperative clinical characteristics can be used to characterize patients' risk for POPF following pancreatectomy. Selective administration of pasireotide only to patients at high risk for grade B/C POPF may maximize the cost-efficacy of prophylactic pasireotide.

The Cost of Postoperative Pancreatic Fistula Versus the Cost of Pasireotide: Results from a Prospective Randomized Trial.

OBJECTIVE: The objective of this study was to determine the costs of clinically significant postoperative pancreatic fistula (POPF) and to evaluate the cost-effectiveness of routine pasireotide use. SUMMARY OF BACKGROUND DATA: We recently completed a prospective randomized trial that demonstrated an 11.7% absolute risk reduction of clinically significant POPF with use of perioperative pasireotide in patients undergoing pancreaticoduodenectomy or distal pancreatectomy [POPF: pasireotide (n = 152), 9% vs placebo (n = 148), 21%; P = 0.006]. METHODS: An institutional modeling system was utilized to obtain total direct cost estimates from the 300 patients included in the trial. This system identified direct costs of hospitalization, physician fees, laboratory tests, invasive procedures, outpatient encounters, and readmissions. Total direct costs were calculated from the index admission to 90 days after resection. Costs were converted to Medicare proportional dollars (MP$). RESULTS: Clinically significant POPF occurred in 45 of the 300 randomized patients (15%). The mean total cost for all patients was MP$23,400 (MP$8,000 - MP$202,500). The mean cost for those who developed clinically significant POPF was MP$39,700 (MP$13,800 - MP$202,500) versus MP$20,500 (MP$8,000 - MP$62,900) for those who did not (P = 0.001). The mean cost of pasireotide within the treatment group (n = 152) was MP$3,300 (MP$300 - MP$3,800). The mean cost was lower in the pasireotide (n = 152) group than the placebo (n = 148) group; however, this did not reach statistical significance (pasireotide, MP$22,800 vs placebo, MP$23,900: P = 0.571). CONCLUSIONS: The development of POPF nearly doubled the total cost of pancreatic resection. In this randomized trial, the routine use of pasireotide significantly reduced the occurrence of POPF without increasing the overall cost of care.

Pasireotide for the Prevention of Pancreatic Fistula Following Pancreaticoduodenectomy: A Cost-effectiveness Analysis.

OBJECTIVE: To determine the cost-effectiveness of perioperative administration of pasireotide for reduction of pancreatic fistula (PF). SUMMARY: PF is a major complication following pancreaticoduodenectomy (PD), associated with significant morbidity and healthcare-related costs. Pasireotide is a novel multireceptor ligand somatostatin analogue, which has been demonstrated to reduce the incidence of PF following pancreas resection; however, the drug cost is significant. This study sought to estimate the cost-effectiveness of routine administration of pasireotide to patients undergoing PD, compared with no intervention from the perspective of the hospital system. METHODS: A decision-analytic model was developed to compare costs for perioperative administration of pasireotide versus no pasireotide. The model was populated using an institutional database containing all PDs performed 2002 to 2012 at a single institution, including data regarding clinically significant PF (International Study Group on Pancreatic Fistula Grade B or C) and hospital-related inpatient costs for 90 days following PD, converted to 2014 $USD. Relative risk of PF associated with pasireotide was estimated from the published literature. Deterministic and probabilistic sensitivity analyses were performed to test robustness of the model. RESULTS: Mean institutional cost of index admissions was $67,417 and $31,950 for patients with and without PF, respectively. Pasireotide was the dominant strategy, associated with savings of $1685, and a mean reduction of 1.5 days length of stay. Univariate sensitivity analyses demonstrated cost-savings down to a PF rate of 5.6%, up to a relative risk of PF of 0.775, and up to a drug cost of $2817. Probabilistic sensitivity analysis showed 79% of simulations were cost saving. CONCLUSIONS: Pasireotide appears to be a cost-saving treatment following PD across a wide variation of clinical and cost scenarios.

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.

Prophylactic pasireotide administration following pancreatic resection reduces cost while improving outcomes.

BACKGROUND AND OBJECTIVES: Pasireotide decreases leak rates after pancreatic resection, though significant drug cost may be prohibitive. We conducted a cost-effectiveness analysis to determine whether prophylactic pasireotide possesses a reasonable cost profile. METHODS: A cost-effectiveness model compared pasireotide administration after pancreatic resection versus usual care, populated by probabilities of clinical outcomes from a randomized trial and hospital costs (2013 US$) from a university pancreatic disease center. Sensitivity analyses were performed to identify influential clinical components of the model. RESULTS: With the cost of pasireotide included, per patient costs of pancreatectomy, including those for readmission, were lower in the intervention arm (41,769 versus 42,159$; net savings of 390$, or 1%). This was associated with a 56% reduction in pancreatic fistula/pancreatic leak/abscess (PF/PL/A; 21.9-9.2%). Pasireotide cost would need to increase by over 15.4% to make the intervention strategy more costly than usual care. Sensitivity analyses exploring variability of key model inputs demonstrated that the three strongest drivers of cost were (i) cost of pasireotide; (ii) probability of readmission; and (iii) probability of PF/PL/A. CONCLUSIONS: Prophylactic pasireotide administration following pancreatectomy is cost savings, reducing expensive post-operative sequealae (major complications and readmissions). Pasireotide should be utilized as a cost-saving measure in pancreatic resection. J. Surg. Oncol. 2016;113:784-788. © 2016 Wiley Periodicals, Inc.

The cost of Pancreatoduodenectomy - An analysis of clinical determinants.

BACKGROUND: Health care spending is increasing the world over. Determining preventable or correctable factors may offer us valuable insights into developing strategies aimed at reducing costs and improving patient care. The aim of this study was to conduct an exploratory analysis of clinical factors influencing costs of Pancreatoduodenectomy (PD). METHODS: The financial and clinical records of 173 consecutive patients who underwent PD at a tertiary care referral centre, between January 2013 and June 2015 were analysed. RESULTS: Complications, by themselves, did not increase costs associated with PD unless they resulted in an increase in the duration of stay more than 11 days. Intraoperative blood transfusion (p-.098) and performance of an end-to-side PJ (p-.043) were independent factors significantly affecting costs. Synchronous venous resections significantly increased costs (p-.006) without affecting duration of stay. Advancing age, hypertension, neurological and respiratory disorders, preoperative endoscopic retrograde cholangiopancreatography (ERCP), performance of a feeding jejunostomy, and surgical complications eg PPH, POPF and DGE significantly increased the duration of stay sufficient enough to influence costs of PD. CONCLUSIONS: It is not the merely the development, but severity of complications that significantly increase the cost of PD by increasing hospital stay. Strategies aimed at reducing intraoperative blood transfusion requirement as well as minimising the development of POPF can help reduce costs. Synchronous venous resections significantly increase costs independent of hospital stay. This study identified nine factors that may be included in the development of a preoperative nomogram that could be used in preoperative financial counselling of patients undergoing PD.

A cost analysis of somatostatin use in the prevention of pancreatic fistula after pancreatectomy.

BACKGROUND: Studies have shown that somatostatin reduces the occurrence of postoperative pancreatic fistula. However, no study to date has analyzed the cost effectiveness of this treatment. The purpose of this study was to analyze the cost effectiveness of prophylactic somatostatin use with respect to pancreatectomy. METHODS: Review of prospectively collected 2002 patient hepato-pancreatico-biliary database from January 2007 to May 2012. Patients received somatostatin prophylactically at the discretion of their surgeon. Data were analyzed using univariate analysis to determine if somatostatin had an effect on imaging costs, lab costs, "other" costs, PT/OT costs, surgery costs, room and board costs, and total hospital costs. RESULTS: A total of 179 patients underwent pancreatectomy at a single teaching institution. Median total hospital costs were 90,673.50 (59,979-743,667) for patients who developed a postoperative pancreatic fistula versus 86,563 (39,190-463,601) for those who did not (p = 0.004). Median total hospital costs were 89,369 (39,190-743,667) for patients who were administered somatostatin versus 85,291 (40,092-463,601) for patients who did not (p = 0.821). CONCLUSIONS: Pancreatic fistulas significantly increase hospital costs, and somatostatin has been shown to decrease the rate of pancreatic fistula formation. Somatostatin has no significant effect on hospital costs.

Clinical and economic consequences of pancreatic fistula after elective pancreatic resection.

BACKGROUND: Postoperative pancreatic fistula is the main cause of morbidity after pancreatic resection. This study aimed to quantify the clinical and economic consequences of pancreatic fistula in a medium-volume pancreatic surgery center. METHODS: Hospital records from patients who had undergone elective pancreatic resection in our department were identified. Pancreatic fistula was defined according to the International Study Group on Pancreatic Fistula (ISGPF). The consequences of pancreatic fistula were determined by treatment cost, hospital stay, and out-patient follow-up until the pancreatic fistula was completely healed. All costs of the treatment are calculated in Euros. The cost increase index was calculated for pancreatic fistula of grades A, B, and C as multiples of the total cost for the no fistula group. RESULTS: In 54 months, 102 patients underwent elective pancreatic resections. Forty patients (39.2%) developed pancreatic fistula, and 54 patients (52.9%) had one or more complications. The median length of hospital stay for the no fistula, grades A, B, and C fistula groups was 12.5, 14, 20, and 59 days, respectively. The hospital stay of patients with fistula of grades B and C was significantly longer than that of patients with no fistula (P<0.001). The median total cost of the treatment was 4952, 4679, 8239, and 30 820 Euros in the no fistula, grades A, B, and C fistula groups, respectively. CONCLUSIONS: The grading recommended by the ISGPF is useful for comparing the clinical severity of fistula and for analyzing the clinical and economic consequences of pancreatic fistula. Pancreatic fistula prolongs the hospital stay and increases the cost of treatment in proportion to the severity of the fistula.

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.

Decrease in clinically relevant pancreatic fistula by coverage of the pancreatic remnant after distal pancreatectomy.

BACKGROUND: Pancreatic fistulas after distal pancreatectomy occur in up to 60% of patients with distal pancreatectomy. Several techniques for closure of the pancreatic stump have been advocated, but the best management of stump closure remains controversial. Our aim was to evaluate the clinical benefits of coverage of the pancreatic resection margin by autologous tissue. METHODS: One hundred seventeen consecutive patients underwent distal pancreatectomy at the university hospital in Heidelberg between May 2009 and September 2010. A coverage procedure was performed in 73 of these patients. All patients were recorded prospectively, and the clinical course was evaluated focusing on the occurrence of pancreatic fistula as defined by the International Study Group on Pancreatic Fistula. A treatment cost analysis was performed. RESULTS: The rate of clinically relevant pancreatic fistulas (types B and C) was decreased in patients with coverage compared to the standard controls (type B, 7% vs 9%; type C, 7% vs 25%; P < .002). Patients with a coverage procedure had a shorter duration of stay in the hospital (P < .02), and treatment costs were lower (P < .001) compared to patients without coverage. CONCLUSION: Coverage of the pancreatic remnant after distal pancreatectomy decreases the rate of clinically relevant pancreatic fistulas, duration of stay, and treatment costs. A randomized trial is needed to verify these results.

Complications nearly double the cost of care after pancreaticoduodenectomy.

BACKGROUND: Despite considerable data focused on the morbidity of pancreaticoduodenectomy (PD), the financial impact of complications has been infrequently analyzed. This study evaluates the impact of the most common complications associated with PD on the cost of care. Additionally, we identified cost centers that were significantly affected by complications. METHODS: A retrospective analysis of a prospective database in a network of community-based teaching hospitals was performed. All patients (n = 145) who underwent PD were included for years 2005 to 2009. Of these, 144 had complete in-hospital cost data. Complications were assessed and classified into major and minor categories according to Dindo et al. Forty-nine cost centers were analyzed for their association with the cost of complications. Univariate and multivariate linear regression analyses were performed. Significance was reported for P < .05. RESULTS: The median cost for PD was $30,937. Patients with major complications had significantly higher median cost compared with those without ($56,224 vs $29,038; P < .001). Independent predictors of increased cost included reoperation; sepsis; pancreatic fistula; bile leak; delayed gastric emptying; and pulmonary, renal, and thromboembolic complications. Cost center analysis showed significant added charges for patients with major complications for blood bank ($1,018), clinical laboratory ($3,731), a computed tomography scan ($4,742), diagnostic imaging ($697), intensive care unit ($4,986), pharmacy ($33,850) and respiratory therapy ($1,090) (P < .05, all). CONCLUSIONS: This study identified the major complications of PD, which are significantly associated with a higher cost. Substantial cost center increases were associated with major complications, particularly in pharmacy ($33,850). Measures aimed at limiting complications through centralization of care or care pathways may reduce the overall cost of care for patients after pancreatic resection.

Laparoscopic and open surgical treatment of left-sided pancreatic lesions: clinical outcomes and cost-effectiveness analysis.

BACKGROUND: Previous studies comparing open distal pancreatectomy (ODP) and laparoscopic distal pancreatectomy (LDP) have found advantages related to minimal-access surgery. Few studies have compared direct and associated costs after LDP versus ODP. The purpose of the current study was to compare perioperative outcomes of patients undergoing LDP and ODP and to assess whether LDP was a cost-effective procedure compared with the traditional ODP. METHODS: A retrospective analysis of a prospectively maintained database of 52 distal pancreatic resections that were performed during a 10-year period was performed. RESULTS: Patients included in the analysis were 16 in the LDP group and 29 in the ODP. Tumors operated laparoscopically were smaller than those removed at open operation, but the length of pancreatic resection was similar. The mean operating time for LDP was longer than ODP (204 ± 31 vs. 160 ± 35; P < 0.0001), whereas blood loss was higher in the open group (365 ± 215 vs. 160 ± 185, P < 0.0001). Morbidity (25 vs. 41; P = 0.373) and pancreatic fistula (18 vs. 20%; P = 0.6) rates were similar after LDP and ODP, as was 30-day mortality (0 vs. 2%; P = 0.565). LDP had a shorter mean length of hospital stay than ODP (6.4 (2.3) vs. 8.8 (1.7) days; P < 0.0001). Operative cost for LDP was higher than ODP (2889 vs. 1989; P < 0.0001). The entire cost of the associated hospital stay was higher in the ODP group (8955 vs. 6714; P < 0.043). The total cost was comparable in LDP and ODP groups (9603 vs. 10944; P = 0.204). CONCLUSIONS: Laparoscopic distal pancreatectomy for left-sided lesions can be performed safely and effectively in selected patients, with reduced hospital stay and operative blood loss. Major complications, including pancreatic leak, were not reduced, whereas total cost was comparable between LDP and ODP. A selective use of LDP seems to be an effective and cost-efficient alternative to ODP.

Comparison of outcomes and costs between laparoscopic distal pancreatectomy and open resection at a single center.

BACKGROUND: The cost implications of laparoscopic distal pancreatectomy (LDP) and a detailed breakdown of hospital expenditures has not been presented in the literature to date. This study aimed to compare hospital costs and short-term clinical outcomes between LDP and open distal pancreatectomy (ODP). METHODS: The authors evaluated all the distal pancreatic resections performed at their center between January 2004 and March 2010. Parametric and nonparametric statistical analysis was used to compare hospital departmental and total hospital costs as well as oncologic and surgical outcomes. RESULTS: A total of 118 cases (42 laparoscopic resections, including 5 conversions, and 76 open resections) were analyzed. The demographic characteristics were similar between the groups except for a predominance of females in the laparoscopic group (P = 0.036). The indications for surgery differed by a paucity of malignant tumors being approached laparoscopically (P < 0.001). Intraoperatively, there were no differences in estimated blood loss, operating room time, or transfusion requirement. The pathologic outcomes did not differ significantly. The median hospital length of stay (LOS) was 5 days (range 3-31 days) for the LDP cohort and 7 days (range 4-19 days) for the ODP cohort (P < 0.001). Postoperative pancreatic fistula occurred for 22 patients, with a higher proportion observed in the LDP group (28.57%; n = 12) than in the open group (13.16%; n = 10; P = 0.05). However, the rates for grade B and higher grade fistula were higher in the ODP group (0 LDP and 4 ODP). The median preadmission and operative costs did not differ significantly. The ODP cohort had significantly higher costs in all other hospital departments, including the total cost. CONCLUSION: LDP is both a cost-effective and safe approach for distal pancreatic lesions. This series showed a shorter LOS and lower total hospital costs for LDP than for ODP, accompanied by equivalent postoperative outcomes.

A grading system can predict clinical and economic outcomes of pancreatic fistula after pancreaticoduodenectomy: results in 755 consecutive patients.

AIM: Postoperative pancreatic fistula (POPF) has a wide range of clinical and economical implications due to the difference of the associated complications and management. The aim of this study is to verify the applicability of the International Study Group of Pancreatic Fistula (ISGPF) definition and its capability to predict hospital costs. METHODS: This is a retrospective study based on prospectively collected data of 755 patients who underwent pancreaticoduodenectomy in our institution between November 1996 and October 2006. A number of 147 patients (19.5%) have developed a POPF according to ISGPF definition. RESULTS: Grade A fistula, which has no clinical impact, occurred in 19% of all cases. Grade B occurred in 70.7% and was successfully managed with conservative therapy or mini-invasive procedures. Grade C (8.8%) was associated to severe clinical complications and required invasive therapy. Pulmonary complications were statistically higher in the groups B and C rather than the group A POPFs (p < 0.005; OR 8). Patients with carcinoma of the ampullary region had a higher incidence of POPF compared to ductal cancer, with a predominance of grade A (p = 0.036). Increasing fistula grades have higher hospital costs (€11,654, €25,698, and €59,492 for grades A, B, and C, respectively; p < 0.001). CONCLUSIONS: The development of a POPF does not always determine a substantial change of the postoperative management. Clinically relevant fistulas can be treated conservatively in most cases. Higher fistula severity corresponds to increased costs. The grading system proposed by the ISGPF allows a correct stratification of the complicated patients based on the real clinical and economic impact of the POPF.

Clinical and economic validation of the International Study Group of Pancreatic Fistula (ISGPF) classification scheme.

OBJECTIVE: The authors sought to validate the ISGPF classification scheme in a large cohort of patients following pancreaticoduodenectomy (PD) in a pancreaticobiliary surgical specialty unit. SUMMARY BACKGROUND DATA: Definitions of postoperative pancreatic fistula vary widely, precluding accurate comparisons of surgical techniques and experiences. The ISGPF has proposed a classification scheme for pancreatic fistula based on clinical parameters; yet it has not been rigorously tested or validated. METHODS: : Between October 2001 and 2005, 176 consecutive patients underwent PD with a single drain placed. Pancreatic fistula was defined by ISGPF criteria. Cases were divided into four categories: no fistula; biochemical fistula without clinical sequelae (grade A), fistula requiring any therapeutic intervention (grade B), and fistula with severe clinical sequelae (grade C). Clinical and economic outcomes were analyzed across all grades. RESULTS: More than two thirds of all patients had no evidence of fistula. Grade A fistulas occurred 15% of the time, grade B 12%, and grade C 3%. All measurable outcomes were equivalent between the no fistula and grade A classes. Conversely, costs, duration of stay, ICU duration, and disposition acuity progressively increased from grade A to C. Resource utilization similarly escalated by grade. CONCLUSIONS: Biochemical evidence of pancreatic fistula alone has no clinical consequence and does not result in increased resource utilization. Increasing fistula grades have negative clinical and economic impacts on patients and their healthcare resources. These findings validate the ISGPF classification scheme for pancreatic fistula.

A prospective study of post-traumatic biliary and pancreatic fistuli. The role of expectant management.

BACKGROUND: Biliary or pancreatic fistulae occur frequently after operative repair of liver or pancreatic injuries. The existing literature is based on a few retrospective series. The objective of this prospective study is to evaluate the clinical course and efficacy of non-operative treatment of biliary fistuli (BF) and pancreatic fistuli (PF) post-traumatic fistulae. STUDY DESIGN: Patients who following a trauma Laparotomy, developed BF or PF were prospectively followed during a 38-month period (June 1999-August 2001). Demographics, injury type and severity, fistula characteristics and daily output, complications, interventions and cost were recorded. Optimal nutrition, wound management, and control of infection were priorities in fistula management. A fistula was considered completely healed if the patient was on regular diet and the output was zero for at least 48 h. RESULTS: Of 160 patients (injury severity score: 21 + 10) with trauma laparotomy for a liver or pancreatic injury, nineteen patients (12%) developed a fistula (11 BF, 8 PF). No patient died. Infections occurred in 45% (5/11) of BF patients and 50% (4/8) of PF patients. Only two patients required an operation, one for biliopericardium and one more for a pancreatic pseudo-cyst. Fistula management was responsible for more than half of the hospital stay and cost. Patients with PF had longer hospital stays (44 + 28 days) and charges (US dollars 345,000 + 218,000) than patients with BF (22 + 12 days and US dollars 103,000 + 61,000, respectively). CONCLUSIONS: Most post-traumatic BF and PF can be managed non-operatively. BF resolves earlier than PF. Both entities are responsible for substantial increases in hospital length of stay and charges.

Somatostatin versus octreotide in the treatment of patients with gastrointestinal and pancreatic fistulas.

BACKGROUND AND PURPOSE: Gastrointestinal and pancreatic fistulas are characterized as serious complications following abdominal surgery, with a reported incidence of up to 27% and 46%, respectively. Fistula formation results in prolonged hospitalization, increased morbidity/mortality and increased treatment costs. Conservative and surgical approaches are both employed in the management of these fistulas. The purpose of the present study was to assess, evaluate and compare the potential clinical benefit and cost effectiveness of pharmacotherapy (somatostatin versus its analogue octreotide) versus conventional therapy. PATIENTS AND METHODS: Fifty-one patients with gastrointestinal or pancreatic fistulas were randomized to three treatment groups: 19 patients received 6000 IU/day of somatostatin intravenously, 17 received 100 microg of octreotide three times daily subcutaneously and 15 patients received only standard medical treatment. RESULTS: The fistula closure rate was 84% in the somatostatin group, 65% in the octreotide group and 27% in the control group. These differences were of statistical significance (P=0.007). Overall mortality rate was less than 5% and statistically significant differences in mortality among the three groups could not be established. Overall, treatment with somatostatin and octreotide was more cost effective than conventional therapy (control group), and somatostatin was more cost effective than octreotide. The average hospital stay was 21.6 days, 27.0 and 31.5 days for the somatostatin, octreotide and control groups, respectively. CONCLUSIONS: Data suggest that pharmacotherapy reduces the costs involved in fistula management (by reducing hospitalization) and also offers increased spontaneous closure rate. Further prospective studies focusing on the above parameters are needed to demonstrate the clinicoeconomic benefits.