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While a systematic quality strategy is of crucial importance for the success of manufacturing companies, the universal applicability and effectiveness of implemented quality management practices were called into question by a number of major product recalls in recent years. This article seeks to illustrate how already simple analyses and early stage design methods can help to better understand one of the potential reasons for these failures, namely the variation inherent in manufacturing, assembly, and use processes. Usually thoroughly controlled in production, it seems as if particularly the risk of unanticipated variation effects remain largely underestimated and thus unaccounted for in design practice, sometimes with disastrous consequences. To foster the awareness of this variation and to illustrate the benefits of its early consideration in product development, this paper reviews one of the most infamous recalls in automotive history, that of the GM ignition switch, from the perspective of Robust Design. It is investigated if available Robust Design methods such as sensitivity analysis, tolerance stack-ups, design clarity, etc. would have been suitable to account for the performance variation, which has led to a number of fatal product defects and the recall of 30 million vehicles. Furthermore, the disclosed legal case files were examined, offering a unique opportunity to examine how technical malfunctioning of the ignition switch could stay undetected long enough to result in fatalities. [ABSTRACT FROM AUTHOR]

This paper identifies, describes and classifies a comprehensive collection of variation reduction principles (VRP) that can be used to increase the robustness of a product and reduce its variation in functional performance. Performance variation has a negative effect on the reliability and perceived quality of a product and efforts should be made to minimise it. The design principles are identified by a systematic decomposition of the Taguchi Transfer Function in combination with the use of existing literature and the authors’ experience. The paper presents 15 principles and describes their advantages and disadvantages along with example cases. Subsequently, the principles are classified based on their applicability in the various development and production stages. The VRP are to be added to existing robust design methodologies, helping the designer to think beyond robust design tool and method application, towards forming product variation management strategies. [ABSTRACT FROM PUBLISHER]

Background: Pancreatic fistula (PF) is one of the most common complications after pancreaticoduodenectomy. There have been no large prospective randomized trials evaluating PF rates comparing invagination versus duct to mucosa pancreaticojejunostomy. We tested the hypothesis that a duct to mucosa pancreaticojejunostomy would reduce the PF rate. Study Design: Between August 2006 and May 2008, 197 patients at two institutions underwent pancreaticoduodenectomy by a total of 8 experienced pancreatic surgeons as part of this prospective randomized trial (clinical trial no. NCT00359320). All patients were stratified by pancreatic texture and randomized to either an invagination or a duct to mucosa pancreaticojejunal anastomosis. Recorded variables included pancreatic duct diameter, operative time, blood loss, complications, and pathology. Primary end point was PF rate, as defined by the International Study Group on Pancreatic Fistula. Secondary end points included PF grade, postoperative length of hospital stay, other morbidities, and mortality. Results: Rate of PF for the entire cohort was 17.8%. There were 23 fistulas (24%) in the duct to mucosa cohort and 12 fistulas (12%) in the invagination cohort (p < 0.05). The greatest risk factor for a PF was pancreas texture: PF developed in only 8 patients (8%) with hard glands, and in 27 patients (27%) with a soft gland. There were two perioperative deaths (both in the duct to mucosa group), with the proximate causes of death being PF, followed by bleeding and sepsis. Conclusions: This dual-institution prospective randomized trial reveals considerably fewer fistulas with invagination compared with duct to mucosa pancreaticojejunostomy after pancreaticoduodenectomy. Results confirm increased PF rates in soft as compared with hard glands. Additional studies are needed to define the optimal technique of pancreatic reconstruction after pancreaticoduodenectomy. [Copyright &y& Elsevier]

Introduction: Resection and drainage operations achieve long-term pain relief in approximately 85% of patients with chronic pancreatitis (CP). In patients who develop recurrent pain, a few data exist on the long-term results of remedial operations.Materials and Methods: Over an 18-year period (1988-2006), 316 patients with CP had primary resection or drainage operations at our institution. Thirty-nine developed recurrent pain and were treated by a remedial resection or drainage operation. Patient demographics, time to symptom recurrence, radiographic anatomic abnormalities, type of remedial operation, postoperative morbidity, and long-term outcomes were analyzed.Results: Thirty-nine patients, 56% female with a mean age of 41 years (range 16-61 years) had either remedial resection: total pancreatectomy (TP; N = 8), pancreaticoduodenectomy (PD; N = 6), distal pancreatectomy (DP; N = 5), or drainage operation: duodenal preserving pancreatic head resection (DPPHR; N = 8), revision of pancreaticojejunostomy (N = 12). TP achieved pain relief in 88% with postoperative complications greater than or equal to grade III in 38% and diabetes in 100%. Drainage operations achieved pain relief in 67% of patients with postoperative complications greater than or equal to grade III in only 8%. Partial parenchymal resections (DPPHR, PD, DP) as a remedial procedure achieved pain relief <50% of the time.Conclusion: Drainage procedures, when anatomically feasible, are the preferred reoperation to treat patients with recurrent pain after failed primary operation for chronic pancreatitis. [ABSTRACT FROM AUTHOR]

Interventional therapy in necrotizing pancreatitis is evolving. Efforts to modify or prevent pancreatic necrosis by intra-arterial infusion of antibiotics and antiproteases have been described. Moreover, traditional approaches to the surgical management of infected pancreatic necrosis are being challenged by a host of endoscopic and percutaneous techniques. While these approaches are potentially valuable additions to interventional therapy in necrotizing pancreatitis, few evidence-based studies are available to support their supplanting more traditional approaches at this time. Cooperative evidence-based multiinstitutional studies will be required to address the validity of these proposals. [ABSTRACT FROM AUTHOR]

Surgical management of patients with pancreatic necrosis (PN) has evolved over the last two decades to include prophylactic antibiotics, initial medical management, and delayed surgical intervention. The purpose of this study is to identify changes in morbidity and mortality rates as our methods of surgical management have evolved. One hundred two consecutive patients (59 males and 43 females, mean age 53 +/- 16 years) with PN managed surgically were classified as group I (1993-2001), after the routine use of prophylactic antibiotics (N = 55), and group II (2002-2005), after the use of International Association of Pancreatology (IAP) guidelines for intervention (N = 47). Age, sex, etiology of pancreatitis, percent of necrosis, infected necrosis, and acute physiology and chronic health evaluation II scores were similar between groups. Despite a significant worsening of Balthazar computed tomography scoring in group II patients (p < 0.0001), operative morbidity (49 [89%] vs 34 [72%], p = 0.03), mortality (10 [18%] vs 2 [4%], p = 0.03), and hospital length of stay (38 +/- 33 days vs 26 +/- 23 days, p = 0.04) were significantly less in group II patients. Current methods of surgical management utilizing IAP guidelines have resulted in a decreased operative morbidity, mortality, and hospital length of stay in patients with PN. [ABSTRACT FROM AUTHOR]

Pancreatic cancer has a poor prognosis with complete surgical resection being the only therapy to offer a realistic chance for long-term survival. The aim of this study is to identify surgery-related variables that influence long-term survival. Between 1990 and 2002, 226 consecutive patients (mean age of 64 ± 11 years) had resection for pancreatic adenocarcinoma. Prognostic variables in these patients were analyzed using univariate and multivariate analysis. Two hundred four patients (90%) had pancreaticoduodenectomy, 13 patients (6%) had distal pancreatectomy, and 9 patients (4%) had a TP. Stage I disease was present in 50 (22%), stage II disease in 170 (75%), and stage III disease in 6 (3%). R0 resections were achieved in 70%. Operative morbidity was 36% and 30-day mortality was 6%. Actual 1-year, 3-year, and 5-year survival rates were 49% (n = 111), 14% (n = 31), and 4% (n = 9). Using multivariate analysis: tumor size, tumor differentiation, obtaining an R0 resection, and lack of postoperative complications were variables associated with long-term survival. Long-term survival in patients with pancreatic cancer after resection remains poor. Achieving a margin negative resection (R0) with no postoperative complications are prognostic variables that can be affected by the surgeon. [Copyright &y& Elsevier]

The aim of this study was to correlate the bactibilia found after preoperative biliary stenting with that of the bacteriology of postoperative infectious complications in patients with obstructive jaundice. One hundred thirty-eight patients (83% malignant and 17% benign etiologies) with obstructive jaundice had both their bile and all postoperative infectious complications cultured. Eighty-six (62%) had preoperative biliary stents (stent group) and 52 (38%) did not (no-stent group). There were no differences for age, sex, incidence of malignancy, type of operation, estimated blood loss, transfusion requirements, hospital length of stay, morbidity, or mortality rates between the two groups. Of 31 infectious complications, 23 were in the stent group and eight were in the no-stent group (P > 0.05), but only 13 (42%) infectious complications had bacteria that were also cultured from the bile. Only wound infection (P = 0.03) and bacteremia (P = 0.04) were more likely to occur in stented patients. Taken together, these data show that preoperative biliary stenting increases the incidence of bactibilia, bacteremia, and wound infection rates but does not increase morbidity, mortality, or hospital length of stay. Jaundiced patients can undergo preoperative biliary stenting while maintaining an acceptable postoperative morbidity rate. [Copyright &y& Elsevier]

Pancreaticoduodenectomy is often avoided in patients with portal or superior mesenteric venous involvement due to the perception that venous resection is complex, morbid, and carries a poor long-term survival. Our recent experience using state-of-the-art imaging and strict resection criteria show that venous reconstruction increases operative time, transfusion requirements, intensive care unit stay, and total hospital length of stay, but has no significant impact on operative morbidity rates, mortality rates, or the incidence of positive histologic margins. Kalpan-Meier life table analysis shows similar survival curves when compared to a contemporary cohort of patients who do not undergo venous reconstruction. [Copyright &y& Elsevier]

: BackgroundUse of appropriate prophylactic antibiotics has been shown to decrease infectious complications and mortality rate in patients with severe acute pancreatitis, but its influence on the bacteriology of secondary pancreatic infection is poorly defined.: Study designOperative cultures from 61 consecutive patients with pancreatic necrosis treated during routine prophylactic antibiotic use (1993–2001) were compared with 34 consecutive patients with necrosis treated before routine antibiotic use (1977–1992).: ResultsThe two groups of patients were similar in demographics, etiology of pancreatitis, and severity of illness. All patients in the antibiotic group received prophylactic antibiotics compared with only 38% (13 of 34) in the control group. Routine broad-spectrum prophylactic antibiotics altered the bacteriology of secondary pancreatic infection in severe acute pancreatitis from predominantly gram-negative coliforms (56% versus 26%, p = 0.005) to predominately gram-positive organisms (23% versus 52%, p = 0.009) without a significant increase in either the rate of β-lactam resistance or fungal infections. The overall hospital stay in patients treated with prophylactic antibiotics was significantly reduced (61 ± 24 days versus 41 ± 28 days, p = 0.002), and there was a trend toward a decline in mortality rate in the antibiotic treatment group.: ConclusionRoutine broad-spectrum prophylactic antibiotic use has altered the bacteriology of secondary pancreatic infection in severe acute pancreatitis from predominantly gram-negative coliforms to predominantly gram-positive organisms without altering the rate of β-lactam resistance or fungal superinfection. [Copyright &y& Elsevier]

We prospectively evaluated quality of life and visual analogue scale pain scores after bilateral thoracoscopic splanchnicectomy in 55 patients with small-duct chronic pancreatitis and abdominal pain. The perioperative morbidity rate was 11% and there were no perioperative deaths. Four late deaths occurred (7%), and three patients were lost to follow-up. Patients were divided into those who had prior operative or endoscopic interventions (N = 38) and those who did not (N = 17). Preoperatively there were no significant differences between the two groups with regard to age, sex, etiology, pain score, or narcotic use. Pain score, narcotic use, and symptoms scales improved significantly in both groups at 3 and 6 months postoperatively (P < 0.0001). The group with no prior surgical or endoscopic intervention did significantly better initially (P < 0.007), and the improvements in their quality-of-life and pain scores continued for the remainder of the study. In contrast, quality-of-life and pain scores in patients who had undergone prior surgical or endoscopic intervention returned to baseline by 12 months postoperatively and remained poor throughout the remainder of the study. Bilateral thoracoscopic splanchnicectomy appears to work best in patients who have had no prior operative or endoscopic interventions. ( J Gastrointest Surg 2002;6:845–854.) [Copyright &y& Elsevier]

Describes the management of chylothorax after thoracoscopic splanchnicectomy treatment of abdominal pains in patients with chronic pancreatitis or pancreatic carcinoma. Complications of thoracoscopic splanchnicectomy; Modes of treatment for postoperative chylothorax; Surgical approaches in the management of chylothorax.

Presents a prospective, randomized trial designed to determine whether a streamlined operating room supply pack was cost-effective in the placement of permanent central venous catheters. Materials and methods used for patients undergoing operative placement of catheter; Results of the study; Goal of the economic analyses that provides a comparison of alternative treatment methods with regard to both cost and outcome.

Abstract: Background: Pancreaticoduodenectomy has undergone numerous technical modifications since the original reported series in 1935, but little focus has been directed to the dissection and ligation of the mesenteric blood supply to the first portion of the jejunum. Methods: Sixty-four patients in whom the device was used were compared to a historical cohort of 128 patients who had undergone pancreaticoduodenectomy at our institution. Results: The technique described provided a rapid, ergonomically efficient method to complete step 5 of pancreaticoduodenectomy. We found no differences in average hospital length of stay (LOS), reoperation rate, morbidity, mortality, or postoperative readmission rates between patients operated on before or after adoption of this technique Conclusion: The Ligasure sealing device (Valleylab, Boulder, CO) provides an excellent, safe alternative to the classic use of clamps and ties when resecting the first portion of the jejunum during pancreaticoduodenectomy. [Copyright &y& Elsevier]

Product requirements serve many purposes in the product development process. Most importantly, they are meant to capture and facilitate product goals and acceptance criteria, as defined by stakeholders. Accurately communicating stakeholder goals and acceptance criteria can be challenging and more often than not, requirements will be subject to simplification, causing ambiguity and uncertainty, with negative consequences for the company and the users. To prevent such incidences, a new approach for creating more complete requirements is proposed in this article. Grounded in robust design theory, the approach uses quality loss functions as one of the five principles, to visualise a more complete set of requirement information in a single figure. In order to validate the potential and applicability of the proposed approach, a new indicator for requirement completeness is introduced, expressing how open the requirements are for interpretation. By applying the method and indicator to a case study from the medical device industry, it was found that less than 45% of the potential for quantification had been utilised. Finally, the robust design requirements specification method was successfully applied to three case study requirements, to illustrate the gains in terms of the level of quantification, transparency, and comprehensiveness of the provided information. [ABSTRACT FROM AUTHOR]

The concept of a function is of great importance in design. This paper describes from theory how designers should reason about functions when designing. This paper introduces the link model, showing how functions and properties link the product and its use, to the perceived value of the product. The important and useful distinction between functions and properties is made along with the distinction between “wirk functions,” which is what the product does when operating, and “use functions,” which is what the product is used for. The paper makes a novel contribution beyond previous literature, showing that not only is a product's behavior or mode of action designed but also the use activity of the end user. Based on the theoretical perspective unfolded, the authors offer nine mind-sets for both design practitioners and researchers to consider when reasoning about functions. [ABSTRACT FROM PUBLISHER]

Objectives: Low-dose ionizing radiation from medical imaging has been indirectly linked with subsequent cancer. Computed tomography (CT) is the gold standard for defining pancreatic necrosis. The primary goal was to identify the frequency and effective radiation dose of CT imaging for patients with necrotizing pancreatitis.Methods: All patients with necrotizing pancreatitis (2003-2007) were retrospectively analyzed for CT-related radiation exposure.Results: Necrosis was identified in 18% (238/1290) of patients with acute pancreatitis (mean age = 53 years; hospital/ICU length of stay = 23/7 days; mortality = 9%). A median of five CTs/patient [interquartile range (IQR) = 4] were performed during a median 2.6-month interval. The average effective dose was 40 mSv per patient (equivalent to 2,000 chest X-rays; 13.2 years of background radiation; one out of 250 increased risk of fatal cancer). The actual effective dose was 63 mSv considering various scanner technologies. CTs were infrequently (20%) followed by direct intervention (199 interventional radiology, 118 operative, 12 endoscopic) (median = 1; IQR = 2). Magnetic resonance imaging did not have a CT-sparing effect. Mean direct hospital costs increased linearly with CT number (R = 0.7).Conclusions: The effective radiation dose received by patients with necrotizing pancreatitis is significant. Management changes infrequently follow CT imaging. The ubiquitous use of CT in necrotizing pancreatitis raises substantial public health concerns and mandates a careful reassessment of its utility. [ABSTRACT FROM AUTHOR]

Abstract: Background: Necrotizing pancreatitis (NP) patients frequently require pancreatic debridement, and have risk factors for incisional hernia (IH). However, no published data exist regarding the incidence of IH in NP. The aim of the current study was to define the incidence of and identify risk factors for developing IH after pancreatic debridement. Methods: Hernia presence was determined by clinical examination and patient interview. Technical and clinical considerations were noted: type of incision, closure, suture material, age, body mass index (BMI), diabetes mellitus (DM), preoperative albumin, and number of operations. Results: Sixty-three (42%) of 149 debrided patients with NP developed IH. IH patients were older (P < .05). No differences in surgical technique or clinical risk factors were seen between groups. Conclusion: The incidence of IH in NP patients requiring operative debridement is substantially higher than that in patients undergoing routine laparotomy. Innovative fascial closure techniques such as primary fascial buttress with nonsynthetic mesh should be considered. [Copyright &y& Elsevier]

Pancreatic surgery in children is a rare occurrence, and this unfamiliarity can be associated with the assumption of significant morbidity and mortality. The indication for pediatric pancreatic surgery and its relationship to postoperative complications and mortality was evaluated. Patients with pancreatic disease requiring surgical intervention from 1992 to 2004 at a tertiary referral center were retrospectively reviewed. Disorders were divided into 3 categories: 1) pancreatitis, 2) trauma, and 3) tumors. Sixty-two patients (28 males and 34 females), average age was 9.5 years (range, 1 week-18 years), underwent 72 operations. Thirty-seven procedures in 30 category I patients, 18 procedures in 15 category II, and 17 operations in 17 category III. There was only one death. A total of 33.9 per cent of the patients had postoperative complications that included: infection (11%), pseudocyst (6%), diabetes mellitus (5.6%), pancreatic fistula (3%), bowel obstruction (1.3%), extracellular fluid (1.3%), pleural effusion (1.3%), and recurrent abdominal pain (13%) (all in category I patients). There was equivalent morbidity between all 3 groups but unique differences with in the categories. Recurrent abdominal pain characterized category I patients, fistulas were more common in category II, and diabetes mellitus was primarily related to near total excisions in category III. Pancreatic surgery in children is associated with a very low mortality (1.6%) and morbidity equal to that of adult patients. Unique types of morbidities occur with each category of disease state. [ABSTRACT FROM AUTHOR]

A product is referred to as robust when its performance is consistent. In current product robustness paradigms, robustness is the responsibility of engineering design. Drawings and 3D models should be released to manufacturing after applying all the possible robust design principles. But there are no methods referred for manufacturing to carry and improve product robustness after the design freeze. This paper proposes a process of inducing product robustness at all stages of product development from design release to the start of mass production. A manufacturing strategy of absorbing all obvious variations and an approach of turning variations to cancel one another are defined. Verified the application feasibility and established the robustness quantification method at each stage. The theoretical and actual sensitivity of different parameters is identified as indicators. Theoretical and actual performance variation and accuracy of estimation are established as robustness metric. Manufacturing plan alignment to design, complimenting the design and process sensitivities, countering process mean shifts with tool deviations, higher adjustable assembly tools are enablers to achieve product robustness. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented in response to the article "Not Just for Trauma Patients: Damage Control Laparotomy in Pancreatic Surgery," by Katherine Morgan, D. Mansker and David B. Adams in the March 12, 2010 issue.

Background: Management and palliation of pancreatic head adenocarcinoma is challenging. End-of-life decision-making is a variable process involving multiple factors. Methods:We conducted a qualitative, physician-based, 40-question international survey characterizing the impact of medical, religious, social, training and system factors on care. Results: A total of 258 international clinicians completed the survey. Respondents were typically fellowship-trained (78%), with a mean of 16 years' experience in a universityaffiliated (93%) hepato-pancreato-biliary group (96%) practice. Most (91%) believed resection is potentially curative. Most patients were discussed preoperatively by multidisciplinary teams (94%) and medical assessment clinics (68%), but rarely critical care (21%). Intraoperative surgical palliation included double bypass or no intervention for locally advanced nonresectable tumours (41% and 49% v. 14% and 85%, respectively, for patients with hepatic metastases). Postoperative admission to the intensive care unit was frequent (58%). Severe postoperative complications were often treated with aggressive cardiopulmonary resuscitation, intubation and critical care (96%), with no defined time points for futility (74%). Admitting surgeons guided most end-of-life decisions (97%). Formal medical futility laws were rarely available (26%). Insurance status did not alter treatment (97%) or palliation (95%) in non-universal care regions. Clinician ex - peri ence, regional culture and training background impacted treatment (all p < 0.05). Conclusion: Despite remarkable overall agreement, geographic and training differences are evident in the treatment and palliation of pancreatic head adenocarcinoma. [ABSTRACT FROM AUTHOR]

Background: Pancreatitis-induced splenic vein thrombosis (PISVT) is an acquired anatomic abnormality that impacts decision making in pancreatic surgery. Despite this influence, its incidence and the rate of associated gastrointestinal (GI) bleeding are imprecisely known. Methods: The MEDLINE, EMBASE, Cochrane Central Register of Clinical Trials and Cochrane Database of Systematic Reviews databases were searched from their inception to June 2010 for abstracts documenting PISVT in acute (AP) or chronic pancreatitis (CP). Two reviewers independently graded abstracts for inclusion in this review. Heterogeneity in combining data was assumed prior to pooling. Random-effects meta-analyses were performed to estimate percentages and 95% confidence intervals. Results: After review of 241 abstracts, 47 studies and 52 case reports were graded as relevant. These represent a cohort of 805 patients with PISVT reported in the literature. A meta-analysis of studies meeting inclusion criteria shows mean incidences of PISVT of 14.1% in all patients, 22.6% in patients with AP and 12.4% in patients with CP. The incidence of associated splenomegaly was only 51.9% in these patients. Varices were identified in 53.0% of patients and were gastric in 77.3% of cases. The overall rate of GI bleeding was 12.3%. Conclusions: Although reported incidences of PISVT vary widely across studies, an overall incidence of 14.1% is reported. Splenomegaly is an unreliable sign of PISVT. Although the true natural history of PISVT remains unknown, the collective reported rate of associated GI bleeding is 12.3%. [ABSTRACT FROM AUTHOR]

Background: Splenic preserving distal pancreatectomy (SPDP) can be accomplished with splenic artery and vein preservation or ligation. However, no data are available on the relative merits of these techniques. The aim of this analysis was to compare the outcomes of splenic preserving distal pancreatectomy with and without splenic vessel preservation. Study Design: From 2002 through 2009, 434 patients underwent distal pancreatectomy and 86 (20%) had splenic preservation. Vessel preservation (VP) was accomplished in 45 and ligation (VL) was performed in 41. These patients were similar with respect to age, American Society of Anesthesiologists class, pathology, surgeons, and minimally invasive approach (79%). For comparison, a matched group of 86 patients undergoing distal pancreatectomy with splenectomy (DP+S) was analyzed. Results: The VP-SPDP procedure was associated with less blood loss than VL-SPDP or DP+S (224 vs 508 vs 646 mL, respectively; p < 0.05). The VP-SPDP procedure also resulted in fewer grade B or C pancreatic fistulas (2% vs 12% vs 14%; p = NS) and splenic infarctions (5% vs 39%; p < 0.01), less overall morbidity (18% vs 39% vs 38%, respectively; p < 0.05) and need for drainage procedure (2% vs 15% vs 16%; p < 0.05), and shorter post-operative length of stay (4.5 vs 6.2 vs 6.6 days; p < 0.05). Conclusions: This analysis suggests that outcomes are (1) best for VP-SPDP and (2) VL-SPDP provides no short-term advantage over distal pancreatectomy with splenectomy. We conclude that splenic VP is preferred when SPDP is performed. [ABSTRACT FROM AUTHOR]

Background: The purpose of the present study was to demonstrate that post-operative morbidity (PM) associated with resections of hilar cholangiocarcinoma (HCCA) is associated with short- and long-term patient survival. Methods: Between 1998 and 2008, 51 patients with a median age of 64 years underwent resection for HCCA at a single institution. Associations between survival and clinicopathologic factors, including peri- and post-operative variables, were studied using univariate and multivariate models. Results: Seventy-six per cent of patients underwent major hepatectomy with resection of the extrahepatic bile ducts. The 30- and 90-day operative mortality was 10% and 12%. The overall incidence of PM was 69%, with 68% of all PM as major (Clavien grades III-V). No difference in operative blood loss or peri-operative transfusion rates was observed for patients with major vs. minor or no PM. Patients with major PM received adjuvant chemotherapy less frequently than patients with minor or no complications 29% vs. 52%, P= 0.15. The 1-, 3- and 5-year overall (OS) and disease-specific survival (DSS) rates for all patients were 65%, 36%, 29% and 77%, 46%, 35%, respectively. Using univariate and multivariate analysis, margin status (27% R1), nodal metastasis (35% N1) and major PM were associated with OS and DSS, P < 0.01. Major PM was an independent factor associated with decreased OS and DSS [hazard ratio (HR) = 3.6 and 2.8, respectively, P < 0.05]. The median DSS for patients with major PM was 14 months compared with 40 months for patients who experienced minor or no PM, P < 0.01. Conclusion: Extensive operations for HCCA can produce substantial post-operative morbidity. In addition to causing early mortality, major post-operative complications are associated with decreased long-term cancer-specific survival after resection of HCCA. [ABSTRACT FROM AUTHOR]

Background: The aim of this analysis was to explore the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database to determine outcomes of patients undergoing debridement for pancreatic and peripancreatic necrosis. Single-institution series suggest that the mortality of patients undergoing pancreatic necrosectomy has improved but remains at 15% to 20%. But no national data have been available for patients with necrotizing pancreatitis. In 2007, a CPT code specific for debridement of pancreatic necrosis became available. Study Design: The ACS-NSQIP Participant Use File was queried for all patients who had debridement of pancreatic and peripancreatic necrosis (CPT code 48105) from January 1, 2007, through December 31, 2007. Patient demographics, observed (O) and expected (E) morbidity and mortality, and indices (O/E) were evaluated. A multivariate stepwise logistic regression was performed to determine predictors of mortality. Results: During this 12-month period, data were accumulated on 161 patients. The mean age was 54 years; 71% were male; and 75% were Caucasian. The mean body mass index was 30.3 kg/m2; 29% had diabetes; and 11% abused alcohol. Forty-two percent were transferred to NSQIP hospitals from other facilities. Overall morbidity was 62%, and 30-day mortality was 6.8%, but morbidity and mortality indices were 0.86 and 0.33, respectively. Increased age and blood urea nitrogen were independent predictors of mortality. Conclusions: These data suggest that patients undergoing debridement for pancreatic and peripancreatic necrosis at ACS-NSQIP hospitals provide a new North American sample and have better than predicted outcomes. We concluded that ACS-NSQIP is a powerful tool to assess contemporary outcomes of uncommon, high-risk procedures. [Copyright &y& Elsevier]

Objective: The aim of this study was to compare the outcomes of enucleation versus resection in patients with small pancreatic, ampullary, and duodenal neuroendocrine tumors (NETs).Methods: Multi-institutional retrospective review identified all patients with pancreatic and peri-pancreatic NETs who underwent surgery from January 1990 to October 2008. Patients with tumors < or =3 cm and without nodal or metastatic disease were included.Results: Of the 271 patients identified, 122 (45%) met the inclusion criteria and had either an enucleation (n = 37) and/or a resection (n = 87). Enucleated tumors were more likely to be in the pancreatic head (P = 0.003) or functioning (P < 0.0001) and, when applicable, less likely to result in splenectomy (P = 0.0003). The rate of pancreatic fistula formation was higher after enucleation (P < 0.01), but the fistula severity tended to be worse following resection (P = 0.07). The enucleation and resection patients had similar operative times, blood loss, overall morbidity, mortality, hospital stay, and 5-year survival. However, for pancreatic head tumors, enucleation resulted in decreased blood loss, operative time, and length of stay compared to pancreaticoduodenectomy (P < 0.05).Conclusion: These data suggest that most outcomes of enucleation and resection for small pancreatic and peri-pancreatic NETs are comparable. However, enucleation has better outcomes than pancreaticoduodenectomy for head lesions and the advantage of preserving splenic function for tail lesions. [ABSTRACT FROM AUTHOR]

Middle segment pancreatectomy (MSP) is a new operation where the advantages of parenchymal preservation are counterbalanced by a high postoperative complication rate and unease among surgeons with adopting a new technique. This study reviews our experience incorporating MSP into our clinical practice focusing on the initial 34 consecutive patients operated on by one surgeon at a single institution between 1998 and 2007. Patients were divided into early (initial 17 operations) and late (subsequent 17 operations) groups for analysis. Thirty-one reconstructions were by Roux-en-y pancreaticojejunostomy and three were by pancreaticogastrostomy. Using multiple linear regression and logistic regression, we found no significant differences in performance outcomes (operative time, blood loss, tumor size, margin negative resection rate, pancreatic fistula rate, hospital length of stay, postoperative complications, and hospital readmission rate) between our early and late experience even after adjusting for potential confounding variables (patient demographics, co-morbidities, neoplasm, pancreatitis). The pancreatic fistula rate in this series was 29.4% (10/34) and they were all International Study Group on Pancreatic Fistula (ISGPF) Grade A (60%) or B (40%). In summary, MSP is an operation with a flat learning curve and acceptable morbidity rate that can be safely incorporated as a parenchymal preserving option by pancreatic surgeons in their clinical practice. [ABSTRACT FROM AUTHOR]

Background: Annular pancreas is rare; only 737 cases have been reported in the English literature. In addition, no large analysis has compared children and adults. Recently, prenatal diagnosis and advances in imaging have led to increased experience with this condition. Study Design: Data from 103 patients (48 children, 55 adults) with annular pancreas, managed from 1992 to 2006, were reviewed. Patients with isolated duodenal atresia, stenosis, or webs were excluded. Results: Median ages at diagnosis were 1 day in children and 47 years in adults. Annular pancreas was more common in girls and women (children, 58%; adults, 69%). Congenital anomalies were more frequent (p < 0.01) in children (71%) than in adults (16%); Down syndrome, cardiac, and intestinal anomalies were most common. Prenatal diagnosis was suspected in 56% of infants, and adults presented with pain (75%), vomiting (24%), pancreatitis (22%), or abnormal liver tests (11%). All children were managed with duodenal bypass. Children were more likely (p < 0.01) to require surgery for associated anomalies. In contrast, adults had fewer duodenal bypass procedures (24%) but more often required endoscopic pancreatobiliary procedures (67%), cholecystectomy (56%), and other pancreatobiliary surgery (20%; p < 0.01). Adults more commonly (p < 0.01) had pancreas divisum (29%) and pancreatobiliary neoplasia (11%). Five children (6%) with multiple anomalies died; all adults survived their operations. Late deaths occurred in 2 children (4%) with multiple anomalies and 3 adults (5%) with pancreatobiliary cancer. Conclusions: Annular pancreas is associated with a spectrum of disease that differs in children and adults. Congenital anomalies are more common in children with annular pancreas; complex pancreatobiliary disorders and malignancy are more frequent in adults. [Copyright &y& Elsevier]

Background: Pancreatic cystic neuroendocrine tumors (CNETs) are rare premalignant conditions. Computed tomography (CT) occasionally demonstrates the hypervascular border characteristic of NETs. Endoscopic ultrasound (EUS) with fine-needle aspiration and immunocytology may be a more consistent means to establish the diagnosis, but no data on the role of EUS are available. This report represents the largest series of CNETs treated to date, documents the role of EUS in preoperative diagnosis, and describes current management.Methods: Retrospective review of our experience with CNETs treated at an academic center between 1999 and 2006.Results: Thirteen patients with CNETs were identified. One had symptoms consistent with a functional tumor; the others were nonfunctional. Twelve were detected by CT; only three had peripheral hypervascularity. Nine were studied with preoperative EUS/immunocytology; each of these demonstrated strong staining for chromogranin and synaptophysin. All were resected: four by pancreaticoduodenectomy, one by total pancreatectomy, and one by enucleation. Perioperative morbidity occurred in 39%. Perioperative mortality was 0%. Average follow-up was 3.3 + 0.5 years. One patient had late hepatic recurrence and ultimately died of disease. Two developed recurrent NET in the context of MEN I and required additional surgery. Twelve are alive with no evidence of disease.Conclusions: EUS-guided immunocytology with staining for neuroendocrine markers is an accurate method to establish the diagnosis of CNET preoperatively. Short- and long-term outcomes after resection are excellent. [ABSTRACT FROM AUTHOR]

Current management of intraductal papillary mucinous neoplasm (IPMN) according to recently published International Consensus Guidelines depends upon distinguishing it from mucinous cystic neoplasms (MCNs). We have previously shown that prostaglandin E(2) (PGE(2)) is increased in pancreatic cancer tissue over normal controls. Thus, we hypothesized that PGE(2) level in pancreatic fluid differentiates IPMN and MCN and is a biomarker of IPMN dysplasia. Pancreatic fluid was collected in 65 patients at the time of endoscopy (EUS or ERCP) or operation (OR) and analyzed by PGE(2) enzyme-linked immunosorbent assay (ELISA). PGE(2) level was correlated with surgical pathologic diagnosis and dysplastic stage. Mean PGE(2) level (pg/microl) in IPMNs (2.2 +/- 0.6) was greater than in MCNs (0.2 +/- 0.1) (p < 0.05). Mean PGE(2) level of IPMN by dysplastic stage was 0.1 +/- 0.01 (low grade), 1.2 +/- 0.6 (medium grade), 4.4 +/- 0.9 (high grade), and 5.0 +/- 2.3 (invasive). Among invasive IPMN, PGE(2) level dropped in advanced cases with pancreatic ductal obstruction by tumor (0.3 +/- 0) vs non-obstructed (8.6 +/- 2.9). PGE(2) level may help in distinguishing IPMN from MCN in patients with known mucinous lesions. PGE(2) level may also be an indicator of malignant progression of IPMN before ductal obstruction by tumor. Prospective evaluation will be necessary to evaluate the clinical role of PGE(2) level in pancreatic fluid. [ABSTRACT FROM AUTHOR]

Current management of intraductal papillary mucinous neoplasm (IPMN) according to recently published International Consensus Guidelines depends upon distinguishing it from mucinous cystic neoplasms (MCNs). We have previously shown that prostaglandin E2 (PGE2) is increased in pancreatic cancer tissue over normal controls. Thus, we hypothesized that PGE2 level in pancreatic fluid differentiates IPMN and MCN and is a biomarker of IPMN dysplasia. Pancreatic fluid was collected in 65 patients at the time of endoscopy (EUS or ERCP) or operation (OR) and analyzed by PGE2 enzyme-linked immunosorbent assay (ELISA). PGE2 level was correlated with surgical pathologic diagnosis and dysplastic stage. Mean PGE2 level (pg/µl) in IPMNs (2.2±0.6) was greater than in MCNs (0.2±0.1) (p<0.05). Mean PGE2 level of IPMN by dysplastic stage was 0.1±0.01 (low grade), 1.2±0.6 (medium grade), 4.4±0.9 (high grade), and 5.0±2.3 (invasive). Among invasive IPMN, PGE2 level dropped in advanced cases with pancreatic ductal obstruction by tumor (0.3±0) vs non-obstructed (8.6±2.9). PGE2 level may help in distinguishing IPMN from MCN in patients with known mucinous lesions. PGE2 level may also be an indicator of malignant progression of IPMN before ductal obstruction by tumor. Prospective evaluation will be necessary to evaluate the clinical role of PGE2 level in pancreatic fluid. [ABSTRACT FROM AUTHOR]

Introduction: Intraductal papillary mucinous neoplasms (IPMNs) of the pancreas are being diagnosed with increased frequency. CT scanning commonly serves as the primary imaging modality before surgery. We hypothesized MRCP provides better characterization of IPMN type/extent, which more closely matches actual pathology.Methods: Of 214 patients treated with IPMN (1991-2006), 30 had both preoperative CT and MRCP. Of these, 18 met imaging study criteria. Independent readers performed retrospective, blinded analyses using standardized criteria for IPMN type and extent.Results: A ductal connection was detected on 73% of MRCP scans and only 18% of CT. IPMN type was classified differently in seven (39%); four (22%) of which were read on CT as having main duct involvement where this was not appreciated on MRCP or found on surgical pathology. MRCP showed multifocal disease in 13(72%) versus only 9(50%) on CT. A different disease distribution was seen in 9(50%). Finally, 101 branch lesions were identified on MRCP compared to 46 on CT.Conclusions: CT falls short of MRCP in detecting a ductal connection, estimating main duct involvement, and identification of small branch duct cysts. These factors influence diagnostic accuracy, cancer risk stratification and operative strategy. MRCP should be employed for optimal management of patients with IPMN. [ABSTRACT FROM AUTHOR]

Pseudoaneurysm (PSA) of the visceral arterial tree is an uncommon but highly lethal complication of pancreatic surgery and pancreatitis. Surgical and angiographic interventions are used in treatment; however, optimal therapy remains unclear. We hypothesized that the natural history of PSA is different in these discrete clinical settings. From 1995-2005, 37 patients with PSA were treated: 13 after pancreatic surgery and 24 in the setting of pancreatitis. Postoperative patients most frequently presented with bleeding (92%), either from the gastrointestinal (GI) tract or a surgical drain. In this group, the diagnosis was most commonly made by angiography (77%), and 62% had a pancreatic fistula. In patients with pancreatitis, abdominal pain was the only presenting symptom in 62%, and GI bleeding was present in 29%. Eighty-seven percent had an associated pseudocyst or fluid collection. Interventional radiologic therapy successfully arrested hemorrhage in all 35 patients in whom it was employed. There were four false negative angiograms, and two patients required repeated interventions for rebleeding. The overall mortality was 14%. Pseudoaneurysms present differently in these two clinical settings, but transcatheter intervention is the first treatment of choice in clinically stable patients. Early recognition and prompt angiographic occlusion leads to improved outcomes. [ABSTRACT FROM AUTHOR]

: BackgroundPrognostic markers for pancreas cancer, such as CEA, CA19-9, ploidy analysis, and S-phase determination using flow cytometry, have not been consistently predictive. We chose to evaluate nuclear proliferation, as measured by the MIB-1 monoclonal antibody and digital image analysis, as a prognostic marker in pancreatic carcinoma, and compare the findings with DNA ploidy and S-phase analysis. MIB-1 identifies the Ki67 antigen present in nuclei of cells in all phases of the cell cycle except G0.: MethodsWe retrospectively reviewed 33 patients with pancreatic adenocarcinoma resected for cure between 1989 and 1994 with available fixed tissue. Sectioned tissue was stained with MIB-1, and the number of positively stained nuclei determined and expressed as a MIB-1 labeling index (LI) by quantitative image analysis. Disaggregated nuclei were analyzed by flow cytometry using standard techniques.: ResultsMIB-1 LI for pancreas cancers was heterogeneous within and between cancers. The MIB-1 LI for the cancers was 28 ± 15 (median 29). There was no correlation between survival and MIB-1 expression (R2 = 0.03). Likewise, there was no correlation between MIB-1 LI and percentage of cells in S-phase, G2/M, or total proliferating cells (S+G2/M; R2 = 0.01), nor was there a difference between MIB-1 LI and ploidy (P = 0.88).: ConclusionsWe conclude that in our patient population, nuclear proliferation in pancreatic cancer, as determined by expression of Ki67 nuclear antigen, does not appear to correlate with survival and is not a useful prognostic marker. Despite intuitive thoughts to the contrary, there is no correlation between cell cycle analysis as determined by flow cytometry and Ki67 expression in pancreas cancer. Current methods of assessing prognosis after curative resection of cancer of the pancreas, including lymph node and margin status, tumor size, and possibly DNA ploidy as determined by flow cytometry, are not augmented by the assessment of nuclear proliferation by image analysis using the MIB-1 monoclonal antibody. [Copyright &y& Elsevier]

Background: Management and palliation of pancreatic head adenocarcinoma is challenging. End-of-life decision-making is a variable process involving multiple factors.Methods: We conducted a qualitative, physician-based, 40-question international survey characterizing the impact of medical, religious, social, training and system factors on care.Results: A total of 258 international clinicians completed the survey. Respondents were typically fellowship-trained (78%), with a mean of 16 years' experience in a university-affiliated (93%) hepato-pancreato-biliary group (96%) practice. Most (91%) believed resection is potentially curative. Most patients were discussed preoperatively by multidisciplinary teams (94%) and medical assessment clinics (68%), but rarely critical care (21%). Intraoperative surgical palliation included double bypass or no intervention for locally advanced nonresectable tumours (41% and 49% v. 14% and 85%, respectively, for patients with hepatic metastases). Postoperative admission to the intensive care unit was frequent (58%). Severe postoperative complications were often treated with aggressive cardiopulmonary resuscitation, intubation and critical care (96%), with no defined time points for futility (74%). Admitting surgeons guided most end-of-life decisions (97%). Formal medical futility laws were rarely available (26%). Insurance status did not alter treatment (97%) or palliation (95%) in non-universal care regions. Clinician experience, regional culture and training background impacted treatment (all p < 0.05).Conclusion: Despite remarkable overall agreement, geographic and training differences are evident in the treatment and palliation of pancreatic head adenocarcinoma. [ABSTRACT FROM AUTHOR]