Morbidity associated with the use of oxaliplatin versus mitomycin C in hyperthermic intraperitoneal chemotherapy (HIPEC) for peritoneal carcinomatosis of colorectal or appendiceal origin: a multi-institutional comparative study.

Background: The raw costs of mitomycin C (MMC) and oxaliplatin for hyperthermic intraperitoneal chemotherapy (HIPEC) differ substantially. We sought to compare the morbidity and toxicity profiles associated with the use of oxaliplatin and MMC in patients undergoing cytoreductive surgery (CRS) and HIPEC for peritoneal carcinomatosis (PC) of colorectal or appendiceal origin, to evaluate whether the costeffectiveness of these 2 agents should dictate drug choice. Methods: We conducted a retrospective multi-institutional study of all patients with PC of colorectal or appendiceal origin treated with CRS-HIPEC using MMC or oxaliplatin from 2010 to 2015. Demographic, perioperative, morbidity, toxicity and cost data were compared between the 2 treatment groups and between cancer-origin subgroups. Results: Forty-two patients treated with MMC and 76 treated with oxaliplatin were included in the study. Baseline demographic and tumour characteristics were comparable in the 2 groups, except that the patients treated with MMC had higher Charlson Comorbidity Index scores. The MMC group had a higher rate of cancer of colorectal origin (76.2% v. 57.9%, p = 0.047) and longer operative times (553 v. 320 min, p < 0.001). In the subgroup of patients whose cancer was of colorectal origin, patients treated with MMC had a higher transfusion rate (50.0% v. 28.6%, p = 0.023) and lower postoperative baseline hemoglobin level (100 v. 119 g/L, p = 0.002) than those treated with oxaliplatin. There was no difference in hematologic toxicity scores after controlling for postoperative anemia. There was no difference in the rates of major complications and 90-day mortality. However, MMC was less costly than oxaliplatin ($724 v. $8928). Conclusion: MMC and oxaliplatin are both suitable agents for HIPEC and are associated with comparable morbidity and toxicity profiles, regardless of cancer origin. Thus, we propose that cost-effectiveness should ultimately dictate drug selection.

Contexte: Les coûts bruts de la mitomycine C (MMC) et de l'oxaliplatine pour la chimiothérapie hyperthermique intrapéritonéale (CHIP) sont très différents. Nous avons voulu comparer la morbidité et la toxicité associées à l'oxaliplatine et à la MMC chez les patients subissant une chirurgie de réduction tumorale (CRT) et une CHIP pour une carcinomatose péritonéale (CP) d'origine colorectale ou appendiculaire afin d'évaluer si le choix des professionnels de la santé devrait reposer sur le rapport coût­efficacité de ces médicaments. Méthodes: Nous avons mené une étude multicentrique rétrospective sur tous les patients qui, entre 2010 et 2015, présentaient une CP d'origine colorectale ou appendiculaire et ont subi une CRT ainsi qu'une CHIP à la MMC ou à l'oxaliplatine. Les données relatives aux caractéristiques démographiques, aux résultats périopératoires, à la morbidité, à la toxicité et aux coûts ont été comparées entre les 2 groupes de traitement et entre les sous-groupes formés en fonction de l'origine du cancer. Résultats: Au total, 42 patients traités à la MMC et 76 patients traités à l'oxaliplatine ont été inclus dans l'étude. Les caractéristiques démographiques et tumorales des 2 groupes avant le traitement étaient semblables, à l'exception de l'indice de comorbidité de Charlson, qui était plus élevé dans le groupe MMC. Le groupe MMC présentait un taux plus important de cancer d'origine colorectale (76,2 % c. 57,9 %; p = 0,047), de même qu'un temps opératoire plus long (553 min c. 320 min; p < 0,001). En ce qui concerne le sous-groupe de patients atteints d'un cancer d'origine colorectale, les personnes traitées à la MMC affichaient un taux de transfusion plus élevé (50,0 % c. 28,6 %; p = 0,023) et un taux d'hémoglobine postopératoire de référence plus bas (100 g/L c. 119 g/L; p = 0,002) que celles traitées à l'oxaliplatine. Une fois l'anémie postopératoire prise en compte, aucune différence n'a été observée quant à la toxicité hématologique. Les taux de complications majeures et de mortalité à 90 jours étaient aussi comparables. La MMC coûtait toutefois moins cher que l'oxaliplatine (724 $ c. 8928 $). Conclusion: La MMC et l'oxaliplatine conviennent à la CHIP, et la morbidité et la toxicité qui y sont associées sont comparables, quelle que soit l'origine du cancer. Nous proposons donc que le choix du médicament à utiliser repose sur le rapport coût­efficacité.

Biliary mucinous cystic neoplasm mimicking a hydatid cyst: a case report and literature review.

BACKGROUND: Biliary mucinous cystic neoplasms are rare cystic lesions of the liver which carry pre-malignant potential. Given the scarcity of reports in the literature, they pose a considerable challenge to clinical management, particularly with regards to accurate pre-operative diagnosis. CASE PRESENTATION: We present the case of a 37-year-old Tunisian woman who presented with subacute right upper quadrant pain and a large multi-loculated cystic lesion, most consistent with a hydatid cyst. She underwent an open right hepatectomy, and pathology surprisingly revealed a biliary mucinous cystadenoma. Herein, we review the current literature on biliary mucinous cystic neoplasms, with a particular emphasis on diagnostic investigations, key radiological features and optimal treatment modalities. CONCLUSION: Biliary mucinous cystic neoplasms require a high index of suspicion and should be managed with complete surgical resection, as conservative techniques are associated with high recurrence rates. Considering the potential for malignant transformation, periodical surveillance imaging is recommended in the post-operative period.

Intra-arterial therapies for unresectable and chemorefractory colorectal cancer liver metastases: a systematic review and meta-analysis.

BACKGROUND: A large proportion of patients with colorectal cancer liver metastases (CRCLM) not amenable to curative liver resection will progress on systemic therapy. Intra-arterial therapies (IAT) including conventional transarterial chemoembolization (cTACE), drug eluting beads (DEB-TACE) and yttrium-90 radioembolization (Y-90) are indicated to prolong survival and palliate symptoms. The purpose of this systematic review and meta-analysis is to compare the survival benefit and radiologic response of three intra-arterial therapies in patients with chemorefractory and unresectable CRCLM. METHODS: A systematic search for eligible references in the Cochrane Library and the EMBASE, MEDLINE and TRIP databases from January 2000 to November 2016 was performed in accordance with PRISMA guidelines. Methodological quality of included studies was assessed using the MINORS scale. One-year overall survival rates and RECIST responder rates were pooled using inverse-variance weighted random-effects models. Overall survival outcomes were collected according to transformed pooled median survivals from first IAT with a subgroup analysis of patients with extrahepatic disease. RESULTS: Twenty-three prospective studies were included and analyzed: 5 cTACE (n = 746), 5 DEB-TACE (n = 222) and 13 Y-90 (n = 615). All but five were clinical trials. Eleven of 13 Y-90 studies were industry funded. Pooled RECIST response rates with 95% confidence intervals (CI) were: cTACE 23% (9.7, 36), DEB-TACE 36% (0, 73) and Y-90 23% (11, 34). The pooled 1-year survival rates with CI were: cTACE, 70% (49, 87), DEB-TACE, 80% (74, 86) and Y-90, 41% (28, 54). Transformed pooled median survivals from first IAT and ranges for cTACE, DEB-TACE and Y-90 were 16 months (9.0-23), 16 months (7.3-25) and 12 months (7.0-15), respectively. Significant heterogeneity in inclusion criteria and reporting of confounders, including previous therapy, tumor burden and post-IAT therapy, precluded statistical comparisons between the three therapies. CONCLUSION: Methodological and statistical heterogeneity precluded consensus on the optimal treatment strategy. Given the common use and significant cost of radioembolization in this setting, a more robust prospective comparative trial is warranted.

Minimally invasive pancreatic resections: cost and value perspectives.

BACKGROUND: The number of minimally invasive pancreatic resections (MIPR) performed for benign or malignant disease, have increased in recent years. However, there is limited information regarding cost/value implications. METHODS: An international conference evaluating MIPR was held during the 12th Bi-Annual International Hepato-Pancreato-Biliary Association (IHPBA) World Congress in Sao Paulo, Brazil, on April 20th, 2016. This manuscript summarizes the presentations that reviewed current topics in cost and value as they pertain to MIPR. RESULTS: Compared to the open approach, MIPR's are associated with higher operative costs but lower postoperative costs. However, measurements of patient value (defined as improvement in both quantity and quality of life) and financial value (using incremental cost-effectiveness ratio) are required to determine the true value at societal level. CONCLUSION: Challenges remain as to how the potential benefits, both to the patient and the healthcare system as a whole, are measured. Research comparing MIPR versus other techniques for pancreatectomy will require appropriate and valid measurement tools, some of which are yet to be refined. Nonetheless, the experience to date would support the continued development of MIPR by experienced surgeons in high-volume pancreatic centers, married with appropriate review and recalibration.

Evaluation of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Carcinomatosis of Colorectal Origin in the Era of Value-Based Medicine.

Peritoneal spread from colorectal cancer is second only to the liver as a site for metastasis. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) is a well-established treatment option for patients with peritoneal carcinomatosis (PC) of colorectal origin. However, due to concerns regarding both its clinical benefit and high cost, its universal adoption as the standard of care for patients with limited peritoneal dissemination has been slow. The purpose of this review was to clarify the clinical utility and cost effectiveness of CRS-HIPEC in the treatment of colorectal PC using the framework of value-based medicine, which attempts to combine both benefit and cost into a single quantifiable metric. Our comprehensive review of the clinical outcomes and cost effectiveness of CRS-HIPEC demonstrate that it is a highly valuable oncologic therapy and a good use of healthcare resources.

Early experience with robotic pancreatic surgery in a Canadian institution.

BACKGROUND: Pancreatic resections have traditionally been associated with substantial morbidity and mortality. The robotic platform is believed to improve technical aspects of the procedure while offering minimally invasive benefits. We sought to determine the safety and feasibility of the first robotic pancreaticoduodenectomies performed at our institution. METHODS: We retrospectively reviewed data on all patients who underwent robotic-assisted pancreaticoduodenectomy (RAPD) between July 2010 and June 2014 and compared them to outcomes of patients undergoing hybrid laparoscopic pancreaticoduodenectomies (HLAPD) during the same time period. RESULTS: Fifteen patients were scheduled for RAPD; 2 were converted to an open approach and 1 to a mini-laparotomy during the laparoscopic portion of the procedure. Patients who had RAPD (n = 12) had a median duration of surgery of 596.6 (range 509-799) minutes, estimated blood loss of 275 (range 50-1000) mL and median length of stay of 7.5 (range 5-57) days. Mean total opioid use up to postoperative day 7 was 142.599 ± 68.2 versus 176.9 ± 112.7 mg equivalents of intravenous morphine for RAPD and HLAPD, respectively. There was no significant difference between RAPD and HLAPD in any parameters, highlighting the safety and feasibility of a step-wise minimally invasive learning platform. Most patients in the RAPD group had malignant pathology (88.2%). Oncologic outcomes were maintained with no significant difference in ability to resect lymph nodes or achieve negative margins. There were 4 (28.5%) Clavien I-II complications and 3 (29.4%) Clavien III- IV complications, 2 of which required readmission. There were no reported deaths at 90 days. Complication, pancreatic leak and mortality rates did not differ significantly from our laparoscopic experience. CONCLUSION: Outcomes of RAPD and HLAPD were comparable at our centre, even during the early stages of our learning curve. These results also highlight the safety, feasibility and patient benefits of a step-wise transition from open to hybrid to fully robotic pancreaticoduodenectomies in a high-volume academic centre.

CONTEXTE: L'ablation du pancréas a de tout temps été associée à une morbidité et une mortalité importantes. Le recours à une plateforme assistée par robot devrait vraisemblablement améliorer les aspects techniques de l'intervention et offrir en même temps les avantages d'une intervention minimalement effractive. Nous avons voulu déterminer l'innocuité et la faisabilité des premières pancréatoduodénectomies assistées par robot effectuées dans notre établissement. MÉTHODES: Nous avons passé en revue de manière rétrospective les données concernant tous les patients ayant subi une pancréatoduodénectomie assistée par robot (PDAR) entre juillet 2010 et juin 2014 et nous les avons comparées aux résultats enregistrés chez les patients ayant subi une pancréatoduodénectomie laparoscopique hybride (PDLH) au cours de la même période. RÉSULTATS: Quinze patients ont été pressentis pour une PDAR; 2 ont plutôt subi une intervention ouverte et 1 a subi une mini-laparotomie durant la portion laparoscopique de l'intervention. Chez les patients soumis à la PDAR (n = 12), la durée médiane de la chirurgie a été de 596,6 (plage de 509 à 799) minutes, les pertes sanguines estimées ont été de 275 (plage de 50 à 1000) mL et la durée médiane du séjour hospitalier a été de 7,5 (plage de 5 à 57) jours. L'utilisation totale moyenne d'opioïdes jusqu'au septième jour postopératoire a été de 142,599 ± 68,2 mg équivalents de morphine intraveineuse contre 176,9 ± 112,7 pour la PDAR et la PDLH, respectivement. On n'a noté aucune différence significative entre la PDAR et la PDLH au plan des paramètres, ce qui souligne l'innocuité et la faisabilité d'une plateforme d'apprentissage séquentielle minimalement effractive. La plupart des patients du groupe soumis à la PDAR étaient atteints d'un cancer (88,2 %). Les paramètres oncologiques se sont maintenus, sans différence significative quant à la capacité de réséquer les ganglions lymphatiques ou d'obtenir des marges négatives. On a dénombré 4 (28,5 %) complications de stade I­II et 3 (29,4 %) de stade III­IV selon la classification de Clavien; 2 de ces dernières ont nécessité une réadmission. On n'a déploré aucun décès à 90 jours. Les taux de complications, de fuite pancréatique et de mortalité n'ont pas différé significativement par rapport à nos interventions laparoscopiques. CONCLUSION: Les résultats de la PDAR et de la PDLH ont été comparables dans notre établissement, même aux premières étapes de notre courbe d'apprentissage. De tels résultats soulignent l'innocuité, la faisabilité et les bienfaits pour les patients d'une transition graduelle des pancréatoduodénectomies ouvertes, hybrides puis entièrement assistées par robot dans un centre universitaire traitant de forts volumes de patients.

Bridging the gap between open and minimally invasive pancreaticoduodenectomy: the hybrid approach.

BACKGROUND: Minimally invasive pancreatic surgery has evolved rapidly, but total laparoscopic pancreaticoduodenectomy has not been widely adopted owing to its technical complexity. Hybrid laparoscopy-assisted pancreaticoduodenectomy (HLAPD) combines the relative ease of open surgery with the benefits of a minimally invasive approach. This study evaluates the safety and effectiveness of the hybrid approach compared with open surgery. METHODS: We retrospectively analyzed data of consecutive patients undergoing either hybrid or open pancreaticoduodenectomy (OPD) at our institution between September 2009 and December 2013. Demographic, operative and oncologic data were collected to compare outcomes between HLAPD and OPD. RESULTS: Our analysis included 33 patients (HLAPD: n = 13; OPD: n = 20). There were no differences in patient demographics, comorbidities or surgical indications. The HLAPD group had significantly lower intraoperative blood loss (450 mL v. 1000 mL, p = 0.023) and shorter length of hospital stay (8 v. 12 d, p = 0.025) than the OPD group. Duration of surgery did not differ significantly between the groups. There were no differences in postoperative analgesic requirements, Clavien grade I/II or grade III/IV complications or 90-day mortality. Oncologic outcomes showed no significant differences in tumour size, R1 resection rate or number of lymph nodes harvested. CONCLUSION: In select patients, HLAPD is a safe and effective procedure with comparable outcomes to conventional open surgery. Wider adoption of the hybrid approach will allow a greater number of patients to benefit from a less invasive procedure while facilitating the transition toward purely minimally invasive pancreaticoduodenectomy.

CONTEXTE: La chirurgie pancréatique minimalement effractive a rapidement évolué, mais la pancréatoduodénectomie laparoscopique totale n'a pas été largement adoptée en raison de sa complexité technique. La pancréatoduodénectomie hybride sous laparoscopie (PDHL) allie la relative facilité de la chirurgie ouverte aux avantages d'une approche minimalement effractive. Cette étude compare l'innocuité et l'efficacité de l'approche hybride à celles de la chirurgie ouverte. MÉTHODES: Nous avons analysé de manière rétrospective les données concernant des patients consécutifs soumis à une pancréatoduodénectomie hybride ou ouverte (PDO) dans notre établissement entre septembre 2009 et décembre 2013. Les données démographiques, opératoires et oncologiques ont été recueillies pour comparer les résultats entre la PDHL et la PDO. RÉSULTATS: Notre analyse a inclus 33 patients (PDHL : n = 13; PDO : n = 20). Il n'y avait aucune différence quant aux caractéristiques démographiques, comorbidités ou indications chirurgicales chez les patients. Le groupe soumis à la PDHL a connu des pertes sanguines peropératoires significativement moindres (450 mL c. 1000 mL, p = 0,023) et un séjour hospitalier significativement plus bref (8 j c. 12 j, p = 0,025) comparativement au groupe soumis à la PDO. La durée de la chirurgie n'a pas significativement différé entre les groupes. On n'a noté aucune différence sur le plan des besoins en analgésiques postopératoires, des complications de grade I/II ou III/IV sur l'échelle de Clavien ou de la mortalité à 90 jours. Quant aux paramètres oncologiques, aucune différence significative n'a été notée pour ce qui est de la taille de la tumeur, du taux de résection R1 ou du nombre de ganglions recueillis. CONCLUSION: Pour certains patients, la PDHL est une intervention sécuritaire et efficace qui donne des résultats comparables à la chirurgie ouverte classique. L'adoption à plus grande échelle de l'approche hybride permettra à plus de patients de bénéficier d'une intervention moins effractive et facilitera la transition complète vers la pancréatoduodénectomie minimalement effractive.

Economic model of observation versus immediate resection of hepatic adenomas.

BACKGROUND AND OBJECTIVES: For small asymptomatic hepatic adenomas (HA), available data are insufficient to establish the superiority of either observation or surgery. We sought to investigate the cost-effectiveness of two initial management strategies. METHODS: We performed a comparative analysis of two theoretical cohorts of 100 patients with small (<5 cm), asymptomatic HA. Discounted cash flow (DCF) models compared the net present value (NPV) of both treatment options at year 10 under three distinct progression rate scenarios. A break-even (BE) analysis was used to determine the BE point at which the NPV for observation and immediate surgery intersect. RESULTS: The NPV for immediate surgery was $1,733,955. The NPV for observation varied between $2,065,315-$2,745,631 for computed tomography (CT), $2,264,575-$2,929,541 for magnetic resonance imaging (MRI), and $802,837-$1,580,413 for ultrasound (US). The BE point was between 6 and 8 years for CT and 5-7 years for MRI. The BE point for US was not reached except in the highest progression rate scenario (12 years). CONCLUSIONS: This study highlights the importance of the underlying progression rate and the cost of imaging when following patients with asymptomatic HA. Overall, US surveillance is the most cost-efficient approach to observing small asymptomatic HA. If cross-sectional imaging is utilized, then immediate surgery is the most cost-effective decision at 5-8 years.

Comparing the clinical and economic impact of laparoscopic versus open liver resection.

BACKGROUND: Laparoscopic liver resection has thus far not gained widespread acceptance among liver surgeons. Valid questions remain regarding the relative clinical superiority of the laparoscopic approach as well as whether laparoscopic hepatectomy carries any economic benefit compared with open liver surgery. OBJECTIVE: The aim of this work is to compare the clinical and economic impact of laparoscopic versus open left lateral sectionectomy (LLS). METHODS: Between May 2002 and July 2008, 44 laparoscopic LLS and 29 open LLS were included in the analysis. Deviation-based cost modeling (DBCM) was utilized to compare the combined clinical and economic impact of the open and laparoscopic approaches. RESULTS: The laparoscopic approach compared favorably with the open approach from both a clinical and economic standpoint. Not only was the median length of stay (LOS) shorter by 2 days in the laparoscopic group (3 versus 5 days, respectively, P = 0.001), but the laparoscopic cohort also benefited from a significant reduction in postoperative morbidity (P = 0.001). Because the groups differed significantly in age and ratio of benign to malignant disease, a subgroup analysis limited to patients with malignant disease was undertaken. The same reduction in LOS and postoperative morbidity was evident within the malignant subgroup undergoing laparoscopic LLS (P = 0.003). The economic impact of the laparoscopic approach was noteworthy, with the laparoscopic approach US$1,527-2,939 more cost efficient per patient compared with the open technique. CONCLUSION: Our study seems not only to corroborate the safety and clinical benefit of the laparoscopic approach but also suggests a fiscally important cost advantage for the minimally invasive approach.

Initial presentation and management of hilar and peripheral cholangiocarcinoma: is a node-positive status or potential margin-positive result a contraindication to resection?

BACKGROUND: Cholangiocarcinoma (CC) frequently presents at an advanced stage and the majority of patients are unresectable at diagnosis. We sought to examine our recent experience with surgical resection for hilar and peripheral CC. METHODS: A review of all CC patients who presented to our multidisciplinary liver cancer center for evaluation of their CC between January 2000 and August 2008 was performed. Demographics, therapeutic management, pathologic characteristics, and overall survival were analyzed. RESULTS: A total of 280 patients were evaluated over the 8-year period, and 222 patients (79%) were unresectable at presentation. Fifty-eight out of 280 patients were candidates for resection, of whom, 51 patients underwent resection. Hilar CC was identified in 27 patients (53%) and peripheral CC was present in 24 patients (47%). Morbidity and 90-day mortality were 61 and 9.8%, respectively. Overall, negative margin (R0) resection was achieved in 26 patients (51%). Using multivariate Cox regression analysis, only margin status was found to be a significant predictor of survival (p = 0.009). Compared with peripheral CC, hilar CC was associated with shorter overall survival (p = 0.001) and higher rates of positive margins (p = 0.001) and perineural invasion (p = 0.02), and no difference in angiolymphatic, portal vein, and lymph node involvement. CONCLUSIONS: Survival benefits can be achieved with resection for cholangiocarcinoma. Given the lack of effective alternative therapy, when confronted with the potential risk of positive margins or isolated nodal disease, we continue to advocate aggressive surgical resection for both hilar and peripheral CC with the ultimate goal of negative margin resection.

Quality assessment in high-acuity surgery: volume and mortality are not enough.

HYPOTHESIS: A new quality assessment model for high-acuity surgery links process improvements with hospital costs and patient-centered outcomes and accurately reflects the clinical and economic impact of variance in patient acuity at the level of the practice and health care professional. DESIGN: Retrospective case series and cost analysis. SETTING: University tertiary care referral center. PATIENTS: A total of 296 patients undergoing elective pancreatic resection in 5 years. MAIN OUTCOME MEASURES: Expected preoperative morbidity (evaluated using POSSUM [Physiologic and Operative Severity Score for the Enumeration of Mortality and Morbidity]) was compared with observed morbidity (according to the Clavien complication scheme) and was correlated with total hospital costs per patient. RESULTS: As volume increased annually, patient acuity (expected morbidity) rose and complications declined. Overall, observed and expected morbidity rates were equal (54.1% vs 55.1%), for an observed-expected ratio of 0.98. Process improvement measures contributed to a steady decrease in the observed-expected morbidity ratio from 1.34 to 0.81 during the 5-year period. This decrease was strongly associated with significant cost savings as total costs per patient declined annually (from $31 541 to $18 829). This performance assessment model predicts that a 0.10 decrease in the observed-expected morbidity ratio equates to a $2549 cost savings per patient in our practice. CONCLUSIONS: Despite increasing patient acuity, better clinical and economic outcomes were achieved across time. Approaches that mitigate the impact of preoperative risk can effectively deliver quality improvement, as illustrated by a reduced observed-expected morbidity ratio. This approach is valuable in analyzing performance and process improvements and can be used to assess intrapractice and interpractice variations in high-acuity surgery.

Deviation-based cost modeling: a novel model to evaluate the clinical and economic impact of clinical pathways.

BACKGROUND: Although clinical pathways were developed to streamline patient care cost efficiently, few have been put to rigorous financial test. This is important today, because payors demand clear solutions to the cost-quality puzzle. We describe a novel, objective, and versatile model that can evaluate and link the clinical and economic impacts of clinical pathways. STUDY DESIGN: Outcomes for 209 consecutive patients undergoing high-acuity surgery (pancreaticoduodenectomy), before and after pathway implementation, were examined. Four grades of deviation (none to major) from the expected postoperative course were defined by merging length of stay with a validated classification scheme for complications. Deviation-based cost modeling (DBCM) links these deviations to actual total costs. RESULTS: Clinical outcomes compared favorably with benchmark standards for pancreaticoduodenectomy. Despite increasing patient acuity, this new pathway shortened length of stay, reduced resource use, and decreased hospital costs. DBCM indicated that fewer deviations from the expected course occurred after pathway implementation. The impacts of complications were less severe and translated to an overall cost savings of $5,542 per patient. DBCM also revealed that as more patients migrated to the expected course within our standardized care path, 50% of overall cost savings ($2,780) was attributable to the pathway alone, and improvements in care over time (secular trends) accounted for the remainder. CONCLUSIONS: DBCM accurately determined the incremental contribution of clinical pathway implementation to cost savings beyond that of secular trends alone. In addition, this versatile model can be customized to other systems' improvements to reveal their true clinical and economic impacts. This is valuable when choices linking quality with cost must be made.

Postoperative pancreatic fistulas are not equivalent after proximal, distal, and central pancreatectomy.

It is uncertain whether postoperative pancreatic fistulas after distal and central pancreatectomies behave similarly to those after pancreaticoduodenectomy. To date, this concept has not been validated either clinically or economically. Overall, 256 consecutive pancreatic resections from October 2001 to February 2006 (184 pancreaticoduodenectomies, 66 distal pancreatectomies, and 6 central pancreatectomies) were evaluated according to the International Study Group of Pancreatic Fistula classification scheme. Pancreatic fistula was defined as any measurable drainage on or after postoperative day 3, with amylase content greater than three times the normal serum value. Outcomes were divided into four grades: (1) no fistula, (2) grade A: biochemical fistula without clinical sequelae, (3) grade B: fistula requiring any therapeutic intervention, or (4) grade C: fistula with severe clinical sequelae. Grades B and C are considered clinically relevant fistulas based on worsening morbidity, increased length of stay, frequent hospital readmission, and increased costs/resource utilization. Clinical and economic outcomes were compared-grade for grade-across the three resection types. Fistulas of any extent (Grades A-C) occurred in one third of all patients; two thirds had no fistula. Overall, there were 16 readmissions (6%), six reoperations (2%), and no deaths attributable to pancreatic fistula. Outcomes between no fistula and grade A patients were identical across resection types, though grade A fistula was more common in distal pancreatectomy. For each resection type, length of stay and costs progressively increased with grades B and C. However, the negative impact of these clinically relevant fistulas varied between resection types. Rates for intensive care unit admission and rehabilitation placement were higher among pancreaticoduodenectomy patients. Total parenteral nutrition and antibiotic use were similar, but percutaneous drainage was used more often for distal pancreatectomy. Grade B fistula was more severe after distal pancreatectomy, as indicated by increased length of stay, readmissions, and total cost. Although reoperation rates for grade C fistulas were equivalent, intervals to reoperation were substantially longer after distal and central pancreatectomies. When classified according to International Study Group of Pancreatic Fistula criteria, clinically relevant pancreatic fistulas behaved differently depending on type of pancreatectomy. This translates into variable severity that guides management decisions, which ultimately dictate clinical outcomes and economic impact.

Diagnostic Laparoscopy with Ultrasound Still Has a Role in the Staging of Pancreatic Cancer: A Systematic Review of the Literature.

Background. The reported incidence of noncurative laparotomies for pancreatic cancer using standard imaging (SI) techniques for staging remains high. The objectives of this study are to determine the diagnostic accuracy of diagnostic laparoscopy with ultrasound (DLUS) in assessing resectability of pancreatic tumors. Study Design. We systematically searched the literature for prospective studies investigating the accuracy of DLUS in determining resectability of pancreatic tumors. Results. 104 studies were initially identified and 19 prospective studies (1,573 patients) were included. DLUS correctly predicted resectability in 79% compared to 55% for SI. DLUS prevented noncurative laparotomies in 33%. Of those, the most frequent DLUS findings precluding resection were liver metastases, vascular involvement, and peritoneal metastases. DLUS had a morbidity rate of 0.8% with no mortalities. DLUS remained superior to SI when analyzing studies published only in the last five years (100% versus 81%), enrolling patients after the year 2000 (74% versus 58%), or comparing DLUS to modern multidimensional CT (100% versus 78%). Conclusion. DLUS seems to still have a role in the preoperative staging of pancreatic cancer. With its ability to detect liver metastases, vascular involvement, and peritoneal metastases, the use of DLUS leads to less noncurative laparotomies.

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.

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.

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.