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.

Asymptomatic patients with unsuccessful percutaneous inferior vena cava filter retrieval rarely develop complications despite strut penetrations through the caval wall.

OBJECTIVE: We established a program for retrieval of inferior vena cava (IVC) filters within our hospital system. When percutaneous retrieval fails, we only recommend open surgical removal for symptoms and other complications. We examined our outcomes with conservative management of unsuccessful percutaneous retrieval and open surgical removal for symptomatic/complicated IVC filters. METHODS: All patients with history of IVC filter placement who were referred to us for retrieval between 2010 and 2016 were evaluated. Before retrieval, patients were evaluated for risk of future venous thromboembolic events and ongoing need for IVC filtration. Asymptomatic patients with unsuccessful percutaneous filter retrieval were recommended to have annual follow-up with plain abdominal radiographs and to take daily low-dose aspirin. Patients with symptoms referable to the indwelling filter and those with complications were offered open surgical removal. RESULTS: There were 213 patients with a history of IVC filter placement who underwent 220 percutaneous attempts for retrieving 214 IVC filters (four patients had two attempts, one patient had three attempts). Technical success in percutaneously retrieving the filter was 180 of 214 (84.1%) at a median of 5.5 months (interquartile range [IQR], 3.5-9.2) from implant. The median filter dwell time was significantly longer in unsuccessful compared with successful retrieval attempts (8.3 months [IQR, 4.3-15.1 months] vs 5.5 months [IQR, 3.2-8.7 months]; P = .011). Of the 34 filters in 33 patients that could not be retrieved percutaneously, all had either significant filter barb penetration through the caval wall or a tilt angle of greater than 15°. The majority of patients (67%) remained asymptomatic without any further complications over a mean follow-up of 24 months (IQR, 12-50 months). No asymptomatic patients developed symptoms or complications over the follow-up period. Two of the five patients who were symptomatic underwent open surgical removal via minilaparotomy. An additional six patients who failed percutaneous retrieval at other institutions were referred to us for open surgical removal owing to symptoms or complications. Technical success for all open surgical removal of IVC filters was 100%. All patients had resolution of their symptoms after percutaneous or open surgical removal. CONCLUSIONS: Asymptomatic patients with unsuccessful percutaneous IVC filter retrieval seem to have low complications in midterm follow-up despite significant filter strut penetration. Without symptoms or other complications, such patients do not require referral for open surgical filter removal. Symptomatic patients can expect low morbidity and resolution of symptoms after percutaneous or open surgical removal. Further studies are needed to determine the cost-effectiveness of routinely removing asymptomatic IVC filters.

Risk Modeling to Optimize Patient Selection for Management of the Descending Thoracic Aortic Aneurysm.

BACKGROUND: A single-institutional study comparing early and long-term outcomes of thoracic endovascular aortic repair (TEVAR) and open surgical repair (OSR) was performed to determine the appropriate treatment option for descending thoracic aortic aneurysm (DTAA). METHODS: Between 2005 and 2014, 438 DTAA patients were treated (TEVAR, 88; OSR, 350). Acute dissection and traumatic injury were excluded. Perioperative and follow-up data were reviewed. Stratified analyses were conducted to identify patients most likely to benefit from TEVAR. A propensity score for TEVAR was developed by logistic regression, and predictive logistic and Cox regression models for death were adjusted for propensity score. RESULTS: TEVAR patients were frequently older women with emergent status, chronic obstructive pulmonary disease, or coronary artery disease. TEVAR had similar immediate (0% vs 1%; p = 0.588) and delayed (5% vs 6%, p = 1.000) motor deficits and early mortality (6% vs 12%, p = 0.121) but lower dialysis (3% vs 18%, p < 0.001), respiratory failure (10% vs 34%, p < 0.001), and intensive care unit stay (2.0 vs 5.0 days, p < 0.001). Early mortality after TEVAR was lower in septuagenarians (3% vs 16%, p < 0.02), glomerular filtration rate of less than 60 mL/min (8% vs 32%, p < 0.049), chronic obstructive pulmonary disease (6% vs 21%, p < 0.02), defined as target population that had fourfold mortality reduction (p < 0.006) attributable to TEVAR. Propensity-adjusted predictors of early mortality predictors included OSR (odds ratio [OR], 4.3; p < 0.024), target population (OR, 7.7; p < 0.001), diabetes (OR, 3; p < 0.009), peripheral vascular disease (OR, 4.7; p < 0.001), and emergent status (OR, 4.6; p < 0.001). Propensity-adjusted determinants of survival were age, glomerular filtration rate of less than 60 mL/min, peripheral vascular disease, chronic obstructive pulmonary disease, and emergent status. CONCLUSIONS: In older patients with significant comorbidities, TEVAR demonstrated superior results compared with OSR and may be preferable in this target population.

The supraclavius muscle is a novel muscular anomaly observed in two cases of thoracic outlet syndrome.

Various anomalous muscles and fibrofascial structures have been described in relation to the anatomy of thoracic outlet syndrome. We describe two patients with a previously undescribed muscle anomaly, which originated laterally near the trapezius muscle, coursed across the supraclavicular space deep to the scalene fat pad, and attached obliquely to the superior undersurface of the medial clavicle, which we have termed the "supraclavius" muscle. The significance of the supraclavius muscle is unknown, but its occurrence in patients with thoracic outlet syndrome indicates that it can be associated with narrowing of the anatomic space adjacent to the neurovascular structures.

A multi-institutional external validation of the fistula risk score for pancreatoduodenectomy.

BACKGROUND: The Fistula Risk Score (FRS), a ten-point scale that relies on weighted influence of four variables, has been shown to effectively predict clinically relevant postoperative pancreatic fistula (CR-POPF) development and its consequences after pancreatoduodenectomy (PD). The proposed FRS demonstrated excellent predictive capacity; however, external validation of this tool would confirm its universal applicability. METHODS: From 2001 to 2012, 594 PDs with pancreatojejunostomy reconstructions were performed at three institutions. POPFs were graded by International Study Group on Pancreatic Fistula standards as grades A, B, or C. The FRS was calculated for each patient, and clinical outcomes were evaluated across four discrete risk zones as described in the original work. Receiver operator curve analysis was performed to judge model validity. RESULTS: One hundred forty-two patients developed any sort of POPF, of which 68 were CR-POPF (11.4 % overall; 8.9 % grade B, 2.5 % grade C). Increasing FRS scores (0-10) correlated well with CR-POPF development (p < 0.001) with a C-statistic of 0.716. When segregated by discrete FRS-risk groups, CR-POPFs occurred in low-, moderate-, and high-risk patients, 6.6, 12.9, and 28.6 % of the time, respectively (p < 0.001). Clinical outcomes including complications, length of stay, and readmission rates also increased across risk groups. CONCLUSION: This multi-institutional experience confirms the Fistula Risk Score as a valid tool for predicting the development of CR-POPF after PD. Patients devoid of any risk factors did not develop a CR-POPF, and the rate of CR-POPF approximately doubles with each subsequent risk zone. The FRS is validated as a strongly predictive tool, with widespread applicability, which can be readily incorporated into common clinical practice and research analysis.

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.

The pancreaticojejunal anastomotic stent: friend or foe?

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 surgeon's 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 ($33,594 vs $22,411; all P < .05). When high-risk cases were scrutinized, P-J stent use did not offer protection, as CR-POPF was uniformly more common when stents were used. Rates and severity of CR-POPF did not increase when the use of stents was abandoned, further implying that they did not confer protection from fistula development. Extended postoperative imaging was available for 23 stented patients. Of these, one-third of stents were retained past 6 weeks, and one-fourth beyond 6 months. Four patients required additional procedures to manage stent-related complications. CONCLUSION: The use of P-J stents does not decrease the incidence or severity of CR-POPF after proximal pancreatic resection, both overall and for high-risk scenarios. In some patients, P-J stents may lead to short- and long-term adverse outcomes.

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.

The obstructed pancreatico-biliary drainage limb: presentation, management, and outcomes.

INTRODUCTION: Obstruction of the pancreatico-biliary (PB) drainage limb following major PB operations creates unique diagnostic and management dilemmas. We describe the etiology and prevalence, as well as diagnostic and therapeutic approaches for this challenging problem. METHODS: Individuals with PB limb obstruction were identified from a cohort of 477 patients undergoing major PB resections or bypasses for benign and malignant (N = 265) diseases from September 2000 to January 2010. Their presentation, management, short-term outcomes, and survival were analyzed. RESULTS: Thirteen patients developed eventual PB limb obstruction with a mean time to presentation of 18.4 months (range 0.5-41.9), representing an overall adjusted incidence of 4%. Presenting symptoms were reflective of limb obstruction (elevated LFTs, jaundice, cholangitis, and pancreatitis). CT scans demonstrated dilation of the PB drainage limb in all 13 patients and evidence of intrahepatic biliary dilation in eight. Endoscopy was not valuable for either diagnostic or therapeutic purposes in the five patients evaluated in this manner. Percutaneous transhepatic biliary drainage (PTC) was pursued in six patients and provided definitive palliation in two, while three were temporized by this modality prior to a definitive operation, and it was employed postoperatively in another. Operative management occurred in 11 of 13 patients. Causative lesions were not accurately predicted by preoperative imaging and included adhesions, limb volvulus, abscess, malignant local recurrence, solitary metastatic disease, and carcinomatosis. Surgical interventions varied (five enteric bypasses, three adhesiolyses, two explorations, and one external limb venting). There were two perioperative mortalities, but limited morbidity otherwise (one myocardial infarction, one wound dehiscence, and one empyema from PTC placement). The median duration of postoperative hospital stay was 9 days, and no patient required readmission for further surgical management. No patients suffered subsequent recurrence of PB obstruction. In follow-up, nine of the remaining 11 patients are deceased with a median survival of 2.3 months (0.6-9.4 months). The other two are alive at a mean follow-up of 48 months. CONCLUSION: Although infrequent, PB limb obstruction occurs for a variety of reasons and most commonly in the setting of an original malignancy. Since numerous therapeutic modalities are available, an improved understanding of the condition is important in managing these complex patients. Decisive operative intervention accurately assesses the cause and extent of the problem and, for most presentations, provides definitive palliation with limited morbidity for this near-terminal event.

Establishing standards of quality for elderly patients undergoing pancreatic resection.

OBJECTIVE: To evaluate pancreatic surgery as a model for high-acuity surgery in elderly patients for immediate and long-term outcomes, predictors of adverse outcomes, and hospital costs. DESIGN: Retrospective case series. SETTING: University tertiary care referral center. PATIENTS: Four hundred twelve consecutive patients who underwent pancreatic resection from October 1, 2001, through March 31, 2008, for benign and malignant periampullary conditions. MAIN OUTCOME MEASURES: Clinical outcomes were compared for elderly (> or = 75 years) and nonelderly patient cohorts. Quality assessment analyses were performed to show the differential impact of complications and resource utilization between the groups. RESULTS: The elderly cohort constituted one-fifth of all patients. Benchmark standards of quality were achieved in this group, including low operative mortality (1%). Despite higher patient acuity, clinical outcomes were comparable to those of nonelderly patients at a marginal cost increase (median, $2202 per case). Cost modeling analysis showed further that minor and moderate complications were more frequent but no more debilitating for elderly patients. Major complications, however, were far more threatening to older patients. In these cases, duration of hospital stay doubled, and invasive interventions were more commonly deployed. CONCLUSIONS: Quality standards for pancreatic resection in the elderly can--and should--mirror those for younger patients. Age-related care, including geriatric consultation, supplemental enteral nutrition, and early rehabilitation placement planning, can be designed to mitigate the impact of complications in the elderly and guarantee quality.

Outcomes in pancreatic resection are negatively influenced by pre-operative hospitalization.

BACKGROUND: Quality improvement in high-acuity surgery increasingly relies on clinical pathways to streamline patient care and to maximize cost-efficiency. Yet, it remains unclear whether immediate pre-operative hospitalization (non-elective resection) influences operative performance and to what extent it alters the post-operative course. METHODS: Retrospective case series, cost analysis.University tertiary care referral centre. Four hundred and twelve consecutive pancreatic resections performed for benign and malignant disease between 2001 and 2008. Outcomes for both elective and non-elective operations were scrutinized, and correlated with deviations from our clinical Carepath for Pancreatic Resection. Observed-to-expected (O/E) morbidity ratios were calculated for each. RESULTS: Overall, 39 patients (10%) required immediate pre-operative hospitalization, 22 (56%) of which were transferred from another hospital. The most common indications were pancreatitis, gastric outlet obstruction, intractable abdominal pain and gastrointestinal bleeding. During a 1- to 2-week hospitalization, 51% of patients underwent endoscopic retrograde cholangio-pancreatography (ERCP), 36% were administered parenteral nutrition, 20% received antibiotics and 15% were transfused blood products. Yet, this pre-operative scenario, at a median cost of $7250 per patient, had no measurable impact on operative performance. Post-operatively, non-elective patients suffered more complications and a higher (O/E) ratio (1.00 vs. 0.93). These outcomes resulted in significantly more deviations from our carepath and an additional $7000 per non-elective case. CONCLUSION: Immediate pre-operative hospitalization has no meaningful impact on operative performance; yet, deviations from a standardized clinical pathway are far more likely after non-elective pancreatic resection, and result in more severe clinical and economic outcomes.

The incidental asymptomatic pancreatic lesion: nuisance or threat?

INTRODUCTION: Although asymptomatic pancreatic lesions (APLs) are being discovered incidentally with increasing frequency, their true significance remains uncertain. Treatment decisions pivot off concerns for malignancy but at times might be excessive. To understand better the role of surgery, we scrutinized a spectrum of APLs as they presented to our surgical practice over defined periods. METHODS: All incidentally identified APLs that were operated upon during the past 5 years were clinically and pathologically annotated. Among features evaluated were method/reason for detection, location, morphology, interventions, and pathology. For the past 2 years, since our adoption of the Sendai guidelines for cystic lesions, we scrutinized our approach to all patients presenting with APLs, operated upon or not. RESULTS: Over 5 years, APLs were identified most frequently during evaluation of: genitourinary/renal (16%), asymptomatic rise in liver function tests (LFTs; 13%), screening/surveillance (7%), and chest pain (6%). APLs occurred throughout the pancreas (body/tail 63%; head/uncinate 37%) with 48% being solid. One hundred ten operations were performed with no operative mortality including 89 resections (distal 57; Whipple 32) and 21 other procedures. Morbidity was equivalent or better than those cases performed for symptomatic lesions during the same time frame. During these 5 years, APLs accounted for 23% of all pancreatic resections we performed. In all, 22 different diagnoses emerged including non-malignant intraductal papillary mucinous neoplasm (IPMN; 17%), serous cystadenoma (14%), and neuroendocrine tumors (13%), while 6% of patients had >1 distinct pathology and 12% had no actual pancreatic lesion at all. Invasive malignancy was present 17% of the time, while carcinoma in situ or metastases was identified in an additional eight patients. Thus, the overall malignancy rate for APLs equals 24% and these patients were substantially older (68 vs 58 years; p = 0.003). An asymptomatic rise in LFTs correlated significantly (p = 0.009) with malignancy. Furthermore, premalignant pathology was found an additional 47% of the time. Seven patients ultimately chose an operation over continued observation for radiographic changes (mean 2.6 years), but none had cancer. In the last 2 years, we have evaluated 132 new patients with APLs, representing 47% of total referrals for pancreatic conditions. Nearly half were operated upon, with a 3:2 ratio of solid to cystic lesions. This differs significantly (p = 0.037) from the previous 3 years (2:3 ratio), reflecting tolerance for cysts <3 cm and side-branch IPMN. Surgery was undertaken more often when a solid APL was encountered (74%) than for cysts (32%). Some solid APLs were actually unresectable cancers. Due to anxiety, two patients requested an operation over continued observation, and neither had cancer. CONCLUSION: APLs occur commonly, are often solid, and reflect a spectrum of diagnoses. Sendai guidelines are not transferable to solid masses but have safely refined management of cysts. An asymptomatic rise in LFTs cannot be overlooked nor should a patient or doctor's anxiety, given the prevalence of cancer in APLs.

Prevention and management of pancreatic fistula.

Despite significant improvements in the safety and efficacy of pancreatic surgery, post-operative pancreatic fistulae remain an unsolved dilemma. These occur when the transected pancreatic gland, pancreatic-enteric anastomosis, or both, leak rendering the patient at significant risk. They are especially important today since indications for resection (IPMN, carcinoma) continue to increase. This review considers definitions and classifications of pancreatic fistulae, risk factors, preventative approaches and offers management strategies for when they do occur. Key citations from the past seventeen years have been scrutinized, and together with personal experience, provide the basis for this review.

Epidural analgesia for pancreatoduodenectomy: a critical appraisal.

INTRODUCTION: Epidural analgesia has emerged as a commonly applied method to improve pain management and reduce perioperative complications in major abdominal surgery. However, there is no detailed analysis of its efficacy for pancreatic operations. This study compares clinical and economic outcomes after epidural and intravenous analgesia for pancreatoduodenectomy. MATERIAL AND METHODS: Data for 233 consecutive patients, who underwent pancreatoduodenectomy, were prospectively acquired and retrospectively reviewed at a single institution, pancreato-biliary specialty practice. From October 2001 to February 2007, all patients were offered thoracic epidural analgesia, and those who declined received intravenous analgesia. Perioperative pain management was dictated as an element of a standardized clinical pathway for pancreatic resections. Clinical and economic outcomes were analyzed and compared for epidural analgesia and intravenous analgesia groups. RESULTS: One hundred eighty-five patients received epidural analgesia, and 48 received intravenous analgesia, with equivalent baseline patient demographics between the groups. Patients administered epidural analgesia had lower pain scores but significantly higher rates of major complications. Pancreatic fistulae and postoperative ileus occurred more frequently, and patients with epidural analgesia more often required discharge to rehabilitation facilities. A trend towards longer hospitalizations was observed among epidural analgesia patients, but total costs were statistically equivalent between the groups. Further analysis demonstrates that 31% of epidural infusions were aborted before anticipated (fourth postoperative day) because of hemodynamic compromise and/or inadequate analgesia. These select patients required more transfusions, aggressive fluid resuscitation, and subsequently suffered even higher rates of gastrointestinal and respiratory complications, all attributing to higher costs. Multivariate analysis demonstrates that preoperative hematocrit concentration less than 36%, elderly age (>75 years), and chronic pancreatitis predict failure of epidural infusions. CONCLUSION: Thoracic epidural analgesia after pancreatic resections is associated with hemodynamic instability, which may compromise enteric anastomoses, gastrointestinal recovery, and respiratory function. These outcomes are exacerbated in poorly functioning epidurals and suggest that epidural analgesia may not be the optimal method for perioperative pain control when pancreatoduodenectomy is performed.

Risk prediction for development of pancreatic fistula using the ISGPF classification scheme.

BACKGROUND: The International Study Group on Pancreatic Fistula (ISGPF) classification scheme has become a useful system for characterizing the clinical impact of pancreatic fistula. We sought to identify predictive factors that predispose patients to fistula, specifically those with clinical relevance (grades B/C), and to describe the clinical and economic significance of risk stratification within this framework. METHODS: Overall, 233 consecutive pancreatoduodenectomies were performed between October 2001 and March 2007 in our institution. Pancreatic fistula is defined according to the ISGPF classification scheme. Logistic regression analysis was performed to identify risk factors for pancreatic fistula development. These features were then analyzed to determine whether additive risk severity equates to worsening clinical and economic impact. RESULTS: Fistulas of any extent occurred in 60 patients, but only 31 (14%) were clinically relevant. There are no identifiable risk factors for grade A biochemical fistulas. Multivariate analysis shows that small pancreatic duct size (<3 mm); soft gland texture; ampullary, duodenal, cystic, or islet cell pathology; and increased intraoperative blood loss (>1,000 ml) are associated with clinically relevant fistulae. An additive effect is further illustrated, in which clinical and economic outcomes progressively worsen as risk profile increases. Each additional risk factor increases the odds of developing a clinically relevant fistula by 52%. CONCLUSIONS: For pancreatoduodenectomy, small duct size; soft gland texture; ampullary, duodenal, cystic, or islet cell pathology; and increased intraoperative blood loss are convincing risk factors for the development clinically relevant fistulae as judged by ISGPF classification. As risk profile accrues, patients suffer more complications, encounter longer hospital stays, and incur greater hospital costs. These outcomes can be predicted in the operating room through accurate delineation of high-risk glands.

Selective administration of prophylactic octreotide during pancreaticoduodenectomy: a clinical and cost-benefit analysis in low- and high-risk glands.

BACKGROUND: The efficacy of prophylactic octreotide after pancreaticoduodenectomy has been rigorously scrutinized, yet few studies have specifically illustrated its impact in patients at high risk for pancreatic fistula. Applying a previously validated clinical classification scheme (International Study Group on Pancreatic Fistula) for postoperative pancreatic fistula severity, we examined whether prophylactic octreotide could effectuate a clinical or fiscal benefit, or both, after pancreatic resection. STUDY DESIGN: There were 227 consecutive patients who underwent pancreaticoduodenectomy from October 2001 to January 2007. At the surgeon's discretion, prophylactic octreotide was administered intraoperatively and continued postoperatively. Clinically relevant fistulas, requiring therapeutic interventions or resulting in severe clinical sequelae, were identified, as were other complications. Through multivariate analysis, risk factors for fistula were defined as soft gland texture; small duct size; ampullary, duodenal, cystic, or islet cell pathology; and increased blood loss. Beyond a traditional review of clinical outcomes, a novel economic cost-benefit analysis of octreotide prophylaxis was performed, with concentration of impact on high-risk glands (one or more risk factors). RESULTS: Overall, 55% of patients had at least one risk factor. Clinically relevant fistulas were present in 14.9% of all patients. High-risk glands resulted in significantly worse clinical and economic outcomes compared with low-risk glands (no risk factors present). Prophylactic octreotide in low-risk glands was neither clinically effective nor cost efficient after pancreaticoduodenectomy, contributing to $781 in overspending per patient--approximately equivalent to a 7-day postoperative course of octreotide. But in patients with high-risk glands, octreotide prophylaxis was associated with a decreased incidence (20% versus 35%) and morbidity of clinically relevant fistulas. These improved clinical outcomes were associated with reduced resource use, translating to considerable cost savings ($11,849) per high-risk patient. CONCLUSIONS: Octreotide prophylaxis is an effective approach to mitigate the negative impact of pancreatic fistulas, but to obtain maximal clinical value and cost benefit, octreotide should be administered exclusively to patients with high-risk glands.

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.