A 2-Year Experience With Enhanced Recovery After Surgery: Evaluation of Compliance and Outcomes in Pancreatic Surgery.

BACKGROUND: Enhanced Recovery After Surgery (ERAS) programs reduce recovery time, length of stay (LOS), and complications after major surgical procedures. PURPOSE: We evaluated our 2-year experience with a newly implemented comprehensive ERAS program at a high-volume center after pancreatic surgery. METHODS: Outcomes, cost, and compliance metrics were assessed in 215 patients who underwent elective pancreatic surgery (pre-ERAS; n = 99; post-ERAS: n = 116). Mann-Whitney U and χ2 tests were used to evaluate continuous and categorical variables. RESULTS: There were significant decreases in LOS and cost in the post-ERAS cohorts. There were significant increases in compliance with ERAS implementation. Postoperative complication, readmission, and survival rates did not increase. CONCLUSIONS: Implementation of ERAS at a large-volume hospital may improve compliance and reduce costs and LOS without increasing adverse outcomes.

Frequency of unplanned surgery in patients with stage IV colorectal cancer receiving palliative chemotherapy with an intact primary: An analysis of SEER-Medicare.

BACKGROUND AND OBJECTIVES: Stage IV colorectal cancer is often treated with palliative chemotherapy with the primary tumor in place. Low rates of unplanned surgical intervention (due to obstruction or perforation) have been reported. We examined a large national dataset to determine the rate of unplanned surgical intervention in these patients. METHODS: Surveillance Epidemiology and End Results-Medicare were queried for patients with metastatic colorectal cancer receiving chemotherapy (1998-2013). Patient who underwent planned surgery to the primary or metastasectomy were excluded. The primary outcome was the need for nonelective surgery. Time to surgery or death was measured. Conditional analyses were performed to determine the risk of surgical intervention at 6-month, 1-, and 2-year after diagnosis. RESULTS: The analytic cohort consisted of 4692 patients (median age = 75). At 24 months, 80% of the patients had died. The overall unplanned intervention rate was 12%. The probability of requiring unplanned surgery between 6 and 12 months was 8.1%; 12 and 24 months = 6.7%, and >24 months = 5.3%. Males, those with right-sided tumors, and older patients were less likely to require surgery. CONCLUSIONS: Patients treated with palliative chemotherapy who are not resected upfront are unlikely to require unplanned surgery. Prophylactic surgery to reduce the risk of perforation or obstruction may not be necessary.

Ex vivo liver resection coupled with associated liver partition and portal vein ligation: Combining existing techniques to achieve surgical resectability.

Incorporation of liver transplant techniques in hepatopancreaticobiliary surgery has created an opportunity for the resection of locally advanced hepatic tumors formerly considered unresectable. A 73-year-old woman presented with cholangiocarcinoma involving inferior vena cava, all three hepatic veins, and right anterior portal pedicle, initially deemed nonoperative. This case demonstrates the first combined application of associating liver partition and portal vein ligation for staged hepatectomy and ex vivo resection to perform an R0. For diseases dependent upon resection, surgical advances and innovations expand the spectrum of interventions through interdisciplinary techniques.

Routine versus difficult cholecystectomy: using predictive analytics to assess patient outcomes.

BACKGROUND: The American College of Surgeons National Surgical Quality Improvement Program® (NSQIP) Surgical Risk. Calculator (SRC) estimates postoperative outcomes. The aim of this study was to develop and validate a specific predictive outcomes model for cholecystectomy procedures. METHODS: Patients who underwent cholecystectomy between 2008 and 2016 and were deemed too high risk for acute care general surgery (GS) and had surgery performed by the Division of Hepatopancreatobiliary Surgery (HPB) were identified. Outcomes of the HPB cholecystectomies were matched against cholecystectomies performed by GS. New predictive models for postoperative outcomes were constructed. Area under the curve was used to assess predictive accuracy for both models and internal validation was performed using bootstrap logistic regression. RESULTS: A total of 169/934 (18%) cholecystectomies were identified as too high risk for GS. These 169 patients were matched with 126 patients who had cholecystectomy performed by GS. For GS and HPB cholecystectomies, the proposed model demonstrated better discriminative ability compared to the SRC based on ROC curves (proposed model: 0.589-0.982; SRC: 0.570-0.836) for each of the predicted outcomes. CONCLUSION: For patients undergoing cholecystectomy, customized models are superior for predicting individual perioperative risk and allow more accurate, patient-specific delivery of care.

Pathologic Complete Response Rates After Neoadjuvant Treatment in Rectal Cancer: An Analysis of the National Cancer Database.

BACKGROUND: Pathologic complete response (pCR) of rectal cancer following neoadjuvant therapy is associated with decreased local recurrence and increased overall survival. This study utilizes a national dataset to identify predictors of pCR in patients with rectal cancer. METHODS: The National Cancer Database was queried for patients with nonmetastatic rectal cancer (2004-2014) who underwent neoadjuvant therapy and surgical resection. Unadjusted associations were assessed using rank-sum tests and χ 2 tests where appropriate. Backward elimination and forward selection multivariable logistic regression models were created to determine the relationship of annual surgical volume with pCR rate, adjusting for preoperative characteristics and radiation-surgery interval. Statistical tests were two-sided, with a significance level of p ≤ 0.05. Analyses were performed using SAS version 9.4. RESULTS: A total of 27,532 patients from 1179 participating hospitals met the inclusion criteria. Generalized linear mixed models demonstrated that the odds of achieving pCR was independently associated with more recent diagnosis, female sex, private insurance, lower grade, lower clinical T classification, lower clinical N classification, increasing interval between the end of radiation and surgery, and treatment at higher-volume institutions. CONCLUSIONS: pCR was associated with favorable tumor factors, insurance status, time between radiation and surgery, and institutional volume. It is not clear what is driving the higher rates of pCR at high-volume institutions. Research targeted at understanding processes that are associated with pCR in high-volume institutions is needed so that similar results can be achieved across the spectrum of facilities caring for patients in this population.

High-Frequency Irreversible Electroporation: Safety and Efficacy of Next-Generation Irreversible Electroporation Adjacent to Critical Hepatic Structures.

Irreversible electroporation (IRE) is a nonthermal ablation modality employed to induce in situ tissue-cell death. This study sought to evaluate the efficacy of a novel high-frequency IRE (H-FIRE) system to perform hepatic ablations across, or adjacent to, critical vascular and biliary structures. Using ultrasound guidance H-FIRE electrodes were placed across, or adjacent to, portal pedicels, hepatic veins, or the gall bladder in a porcine model. H-FIRE pulses were delivered (2250 V, 2-5-2 pulse configuration) in the absence of cardiac synchronization or intraoperative paralytics. Six hours after H-FIRE the liver was resected and analyzed. Nine ablations were performed in 3 separate experimental groups (major vessels straddled by electrodes, electrodes placed adjacent to major vessels, electrodes placed adjacent to gall bladder). Average ablation time was 290 ± 63 seconds. No electrocardiogram abnormalities or changes in vital signs were observed during H-FIRE. At necropsy, no vascular damage, coagulated-thermally desiccated blood vessels, or perforated biliary structures were noted. Histologically, H-FIRE demonstrated effective tissue ablation and uniform induction of apoptotic cell death in the parenchyma independent of vascular or biliary structure location. Detailed microscopic analysis revealed minor endothelial damage within areas subjected to H-FIRE, particularly in regions proximal to electrode insertion. These data indicate H-FIRE is a novel means to perform rapid, reproducible IRE in liver tissue while preserving gross vascular/biliary architecture. These characteristics raise the potential for long-term survival studies to test the viability of this technology toward clinical use to target tumors not amenable to thermal ablation or resection.

Pediatric and Adolescent Melanoma: A National Cancer Data Base Update.

BACKGROUND: Studies suggest that the biology of pediatric and adolescent melanoma differs from that of adult disease. We report the largest series to date examining the natural history of pediatric and adolescent melanoma. We aim to elucidate the natural history of pediatric and adolescent melanoma and to examine the appropriateness of diagnostic and therapeutic modalities developed for adults and that are currently being used in children. METHODS: A retrospective cohort study was conducted of patients with an index diagnosis of cutaneous non-metastatic melanoma from 1998 to 2011 using the National Cancer Data Base (NCDB; n = 420,416). Three age-based cohorts were analyzed: 1-10 years (pediatric), 11-20 years (adolescent), and ≥21 years (adult). Multivariate analyses were used to identify factors associated with overall survival (OS). RESULTS: Pediatric melanoma patients have longer OS than their adolescent (hazard ratio [HR] 0.50, 95 % CI 0.25-0.98) and adult counterparts (HR 0.11, 95 % CI 0.06-0.21). Adolescents have longer OS than adults. No difference was found in OS in pediatric patients who are node-positive versus node-negative. In pediatric patients, sentinel lymph node biopsy and completion lymph node dissection are not associated with increased OS. In adolescents, nodal positivity is a significant negative prognostic indicator (HR 4.82, 95 % CI 3.38-6.87). CONCLUSIONS: Age-based differences in melanoma outcomes warrant different considerations for diagnostic and therapeutic approaches in each group in order to maximize quality of life while minimizing complications and costs. Prospective, multicenter studies should evaluate the role of diagnostic procedures for pediatric patients.

Postmarketing Analysis of a Novel, Cordless Ultrasonic Dissector.

Introduction Tissue dissection and vessel sealing is performed using a variety of energy sources and surgical devices. We describe the postmarketing analysis of a cordless ultrasonic dissector and vessel sealer in a series of general and gynecological procedures. Methods Patients were prospectively screened and consented for participation. Data collected included demographics, device activations/seals and failures, and patient complications. Surgeons were surveyed following each case. Data was analyzed using standard statistical methods. Results A total of 110 patients were consented and participated in the study. The most frequently performed procedures were bilateral salpingo-oophorectomy (n = 48) and total laparoscopic hysterectomy (n = 36). Mean age was 54.2 years and 79.2% were female. The most frequent number of device activations per case was between 26 and 50 (36.6%). Five failed seals occurred out of 4858 total estimated seals (0.11%). Failed seals were felt to be due to thickened, scarred tissue not amenable to device compression. There were no patient intraoperative complications related to the device itself. Overall, surgeons felt the device was extremely easy to use (97.6%) and no visual obstruction due to steam from the device was encountered (95%). Ninety-five percent of surgeons felt the device was beneficial for soft tissue dissection and vessel sealing. Conclusion Sonicision is safe and effective for use in dissection of soft tissues and vessel sealing in a variety of laparoscopic and open procedures. In this study, there were no complications related to the device itself. The remarkable cordless design of this device enhances its ease of use with overall excellent effectiveness.

Comparing early and delayed repair of common bile duct injury to identify clinical drivers of outcome and morbidity.

BACKGROUND: Outcomes following repair of common bile duct injury (CBDI) are influenced by center and surgeon experience. Determinants of morbidity related to timing of repair are not fully described in this population. METHODS: Patients with CBDI managed surgically at a single center from January 2008 to June 2015 were retrospectively reviewed. Outcomes of patients undergoing early (≤48 h from injury) and delayed (>48 h) repair were compared. Predictive modeling for readmission was performed for patients undergoing delayed repair. RESULTS: In total, 61 patients underwent surgical biliary reconstruction. Between the early and delayed repair groups, no differences were found in patient demographics, injury classification subtype, vasculobiliary injury (VBI) incidence, hospital length of stay, 30-day readmission rate, or 90-day mortality rate. Patients undergoing delayed repair exhibited increased chance of readmission if VBI was present or if multiple endoscopic procedures were performed prior to repair. A predictive model was constructed with these variables (ROC 0.681). CONCLUSION: When managed by a tertiary hepatopancreatobiliary center, equivalent outcomes can be realized for patients undergoing early and delayed repair of CBDI. Establishment of evidence-based consensus guidelines for evaluation and treatment of CBDI may allow identification of factors that drive morbidity and predict clinical outcomes in this population.

Induction of rapid, reproducible hepatic ablations using next-generation, high frequency irreversible electroporation (H-FIRE) in vivo.

INTRODUCTION: Irreversible electroporation (IRE) offers an alternative to thermal tissue ablation in situ. High-frequency IRE (H-FIRE), employing ultra-short bipolar electrical pulses, may overcome limitations associated with existing IRE technology to create rapid, reproducible liver ablations in vivo. METHODS: IRE electrodes (1.5 cm spacing) were inserted into the hepatic parenchyma of swine (n = 3) under surgical anesthesia. In the absence of paralytics or cardiac synchronization five independent H-FIRE ablations were performed per liver using 100, 200, or 300 pulses (2250 V, 2-5-2 µs configuration). Animals were maintained under isoflurane anesthesia for 6 h prior to analysis of ablation size, reproducibility, and apoptotic cell death. RESULTS: Mean ablation time was 230 ± 31 s and no EKG abnormalities occurred during H-FIRE. In 1/15 HFIRE's minor muscle twitch (rectus abdominis) was recorded. Necropsy revealed reproducible ablation areas (34 ± 4 mm(2), 88 ± 11 mm(2) and 110 ± 11 mm(2); 100-, 200- and 300-pulses respectively). Tissue damage was predominantly apoptotic at pulse delivery ≤200 pulses, after which increasing evidence of tissue necrosis was observed. CONCLUSION: H-FIRE can be used to induce rapid, predictable ablations in hepatic tissue without the need for intraoperative paralytics or cardiac synchronization. These advantages may overcome limitations that restrict currently available IRE technology for hepatic ablations.

Cancers Metastatic to the Liver.

The liver is a common site of metastatic cancer spread, and metastatic lesions are the most common malignant liver tumors. Diagnosis of liver metastases often is established based on clinical assessment, laboratory tests, and appropriate imaging. Surgical resection is the treatment of choice for resectable colorectal and neuroendocrine liver metastases. Long-term survival outcome data after treatment of hepatic metastases of noncolorectal non-neuroendocrine tumors are less robust. The treatment strategy for patients with liver metastases should be determined case by case in a multidisciplinary setting.

Patient Factors Lead to Extensive Variation in Outcomes and Cost From Cholecystectomy.

BACKGROUND: Cholecystectomy is a common procedure with significantly varied outcomes. We analyzed differences in comorbidities, outcomes, and cost of cholecystectomy by acute care surgery (ACS) versus hepatopancreaticobiliary (HPB) surgery. STUDY DESIGN: Patients were retrospectively identified between 2008 and 2015. Exclusion criteria included the following: (1) part of another procedure; (2) abdominal trauma; (3) ICU admission; vasopressors. RESULTS: One hundred and twenty-six ACS and 122 HPB patients were analyzed. The HPB subset had higher burden of comorbid disease and significantly lower projected 10-year survival (87.4% ACS vs 68.5% HPB, P < .0001). Median lengths of stay were longer in HPB patients (2 vs 5 days, P < .0001) as were readmission rates (30-day 5.6% vs 13.1%, P = .040; 90-day 7.9% vs 20.5%, P = .005). Median cost was higher including operative supply cost ($969.42 vs $1920.66, P < .0001) and total cost of care ($7340.66 vs $19 338.05, P < .0001). A predictive scoring system for difficult gallbladders was constructed and a phone application was created. CONCLUSION: Cholecystectomy in a complicated patient can be difficult with longer hospital stays and higher costs. The utilization of procedure codes to explain disparities is not sufficient. Incorporation of comorbidities needs to be addressed for planning and reimbursement.

Current State of Enhanced Recovery After Surgery in Hepatopancreatobiliary Surgery.

For over two decades, enhanced recovery pathways have been implemented in many surgical disciplines, most notably in colorectal surgery. Since 2001, the Enhanced Recovery After Surgery (ERAS®) Study Group has developed a main protocol comprising 24 evidence-based core items. While these core items unite similar preoperative, intraoperative, and postoperative principles across surgical subspecialties, variations and modifications exist to these core items based on unique considerations for each surgical subspecialty. This overview will summarize overarching principles for ERAS within hepatopancreaticobiliary (HPB) surgery, first summarizing Pancreaticoduodenectomy and Hepatectomy ERAS Society Guidelines. Specifically, principles and areas of current debate regarding preoperative oral carbohydrate loading/fasting, perioperative fluid management, and analgesia will be discussed. While institutions are beginning to realize both clinical and financial benefits of ERAS within HPB surgery, enhanced recovery remains a relatively recent phenomenon within the field. The complex patient population, high morbidity, and resource-intensive care involved in HPB surgery certainly warrant special consideration. To continue to promote improved clinical outcomes in a cost-effective manner, the ERAS Society will continue to actively address concerns and ensure all recommendations are based on the most up-to-date scientific evidence within the field of HPB surgery.

Developing and validating a center-specific preoperative prediction calculator for risk of pancreaticoduodenectomy.

BACKGROUND: The American College of Surgeons (ACS) Surgical Risk Calculator predicts postoperative risk based on preoperative variables. The ACS model was compared to an institution-specific risk calculator for pancreaticoduodenectomy (PD). METHODS: Observed outcomes were compared with those predicted by the ACS and institutional models. Receiver operating characteristic (ROC) analysis evaluated the models' predictive ability. Institutional models were evaluated with retrospective and prospective internal validation. RESULTS: Brier scores indicate equivalent aggregate predictive ability. ROC values for the institutional model (ROC: 0.675-0.881, P < 0.01) indicate superior individual event occurrence prediction (ACS ROC: 0.404-0.749, P < 0.01-0.860). Institutional models' accuracy was upheld in retrospective (ROC: 0.765-0.912) and prospective (ROC: 0.882-0.974) internal validation. CONCLUSIONS: Identifying higher-risk patients allows for individualized care. While ACS and institutional models accurately predict average complication occurrence, the institutional models are superior at predicting individualized outcomes. Predictive metrics specific to PD center volume may more accurately predict outcomes.

Robotic longitudinal pancreaticojejunostomy for chronic pancreatitis: Comparison of clinical outcomes and cost to the open approach.

BACKGROUND: This study compares clinical and cost outcomes of robot-assisted laparoscopic (RAL) and open longitudinal pancreaticojejunostomy (LPJ) for chronic pancreatitis. METHODS: Clinical and cost data were retrospectively compared between open and RAL LPJ performed at a single center from 2008-2015. RESULTS: Twenty-six patients underwent LPJ: 19 open and 7 RAL. Two robot-assisted cases converted to open were included in the open group for analysis. Patients undergoing RAL LPJ had less intraoperative blood loss, a shorter surgical length of stay, and lower medication costs. Operation supply cost was higher in the RAL group. No difference in hospitalization cost was found. CONCLUSIONS: Versus the open approach, RAL LPJ performed for chronic pancreatitis shortens hospitalization and reduces medication costs; hospitalization costs are equivalent. A higher operative cost for RAL LPJ is mitigated by a shorter hospitalization. Decreased morbidity and healthcare resource economy support use of the robotic approach for LPJ when appropriate.

Robotic pancreaticoduodenectomy.

Pancreaticoduodenectomy (PD) is considered one of the most complex and technically challenging abdominal surgeries performed by general surgeons. With increasing use of minimally invasive surgery, this operation continues to be performed most commonly in an open fashion. Open PD (OPD) is characterized by high morbidity and mortality rates in published series. Since the early 2000s, use of robotics for PD has slowly evolved. For appropriately selected patients, robotic PD (RPD) has been shown to have less intraoperative blood loss, decreased morbidity and mortality, shorter hospital length of stay, and similar oncological outcomes compared with OPD. At our high-volume center, we have found lower complication rates for RPD along with no difference in total cost when compared with OPD. With demonstrated non-inferior oncologic outcomes for RPD, the potential exists that RPD may be the future standard in surgical management for pancreatic disease. We present a case of a patient with a pancreatic head mass and describe our institution's surgical technique for RPD.

Robotic transgastric cystgastrostomy and pancreatic debridement in the management of pancreatic fluid collections following acute pancreatitis.

Pancreatic and peripancreatic fluid collections may develop after severe acute pancreatitis. Organized fluid collections such as pancreatic pseudocyst and walled-off pancreatic necrosis (WOPN) that mature over time may require intervention to treat obstructive or constitutional symptoms related to the size and location of the collection as well as possible infection. Endoscopic, open surgical and minimally invasive techniques are described to treat post-inflammatory pancreatic fluid collections. Surgical intervention may be required to treat collections containing necrotic pancreatic parenchyma or in locations not immediately apposed to the stomach or duodenum. Comprising a blend of the surgical approach and the clinical benefits of minimally invasive surgery, the robot-assisted technique of pancreatic cystgastrostomy with pancreatic debridement is described.