Hepatocellular Carcinoma: Surgical Management and Evolving Therapies.

Hepatocellular carcinoma (HCC) is the fifth most common cancer in men and the eighth most common cancer in women worldwide. It is also the second leading cause of cancer death worldwide, with 780,000 deaths in 2018. Seventy-two percent of HCC cases occur in Asia, 10% in Europe, 8% in Africa, 5% in North America, and 5% in Latin America (Singal et al. in J Hepatol 72(2):250-261, 2020 [1]).

Textbook oncologic outcome in pancreaticoduodenectomy: Do regionalization efforts make sense?

BACKGROUND AND OBJECTIVES: Few empiric studies evaluate the effects of regionalization on pancreatic cancer care. METHODS: We queried the National Cancer Database to identify patients undergoing pancreaticoduodenectomy for clinical stage I/II pancreatic adenocarcinoma between 2006 and 2015. Facilities were categorized by annual pancreatectomy volume. Textbook oncologic outcome was defined as a margin negative resection, appropriate lymph node assessment, no prolonged hospitalization, no 30-day readmission, no 90-day mortality, and timely receipt of adjuvant chemotherapy. Multivariable regression adjusted for comorbid disease, pathologic stage, and facility characteristics was used to evaluate the relationship between facility volume and textbook outcome. RESULTS: Sixteen thousand six hundred and two patients underwent pancreaticoduodenectomy; 3566 (21.5%) had a textbook outcome. Operations performed at high volume centers increased each year (45.8% in 2006 to 64.2% in 2015, p < 0.001) as did textbook outcome rates (14.3%-26.2%, p < 0.001). Surgical volume was associated with textbook outcome. High volume centers demonstrated higher unadjusted rates of textbook outcome (25.4% vs. 11.8% p < 0.01) and increased adjusted odds of textbook outcome relative to low volume centers (odds ratio: 2.39, [2.02, 2.85], p < 0.001). Textbook outcome was associated with improved overall survival independent of volume. CONCLUSIONS: Regionalization of care for pancreaticoduodenectomy to high volume centers is ongoing and is associated with improved quality of care.

Biliary Enteric Reconstruction After Biliary Injury: Delayed Repair Is More Costly Than Early Repair.

BACKGROUND: Bile duct injury (BDI) during cholecystectomy requiring biliary enteric reconstruction (BER) is associated with increased risk of postoperative mortality and substantive increases in costs of care. The impact of the timing of repair on overall costs of care is poorly understood. MATERIALS AND METHODS: The Healthcare Cost and Utilization Project Florida State databases (2006-2015) were queried to identify patients undergoing BER within 1-y of cholecystectomy performed for benign biliary disease. Patients were then categorized by the time interval between cholecystectomy to BER: early (≤3 d), intermediate (4 d to 6 wk), or delayed (>6 wk). By repair timing strategy, 1-y outcomes were aggregated, including charges, inpatient costs, aggregate length of stay, and inpatient mortality. RESULTS: Of 563,887 patients undergoing cholecystectomy, 1168 required a BER (0.21%) within 1-y of cholecystectomy. Early BER was performed in 560 patients (47.9%), intermediate BER in 439 patients (37.6%), and delayed BER in 169 (14.5%) patients. On multivariable analysis adjusting for patient, procedure, and facility factors, intermediate BER demonstrated an increased risk of mortality (odds ratio 2.04, 95% confidence interval [CI]: 1.16-3.56) and increased aggregate inpatient cost (+$12,472; 95% CI: $6421-$18,524) relative to early BER. There was no notable difference in adjusted risk of inpatient mortality between the early and delayed BER cohorts (odds ratio 0.90; 95% CI: 0.32-1.25), but delayed BER was associated with increased aggregate inpatient costs (+$45,111; 95% CI: $36,813-$53,409). CONCLUSIONS: When compared with delayed BER, early repair was associated with shorter aggregate inpatient hospitalization without increased postoperative mortality. Intermediate timing of repair is associated with increased costs and risk of mortality.

Trends, Cost, and Mortality From Sepsis After Trauma in the United States: An Evaluation of the National Inpatient Sample of Hospitalizations, 2012-2016.

OBJECTIVES: Identification and outcomes in patients with sepsis have improved over the years, but little data are available in patients with trauma who develop sepsis. We aimed to examine the cost and epidemiology of sepsis in patients hospitalized after trauma. DESIGN: Retrospective cohort study. PATIENTS: National Inpatient Sample. INTERVENTIONS: Sepsis was identified between 2012 and 2016 using implicit and explicit International Classification of Diseases, Ninth and Tenth Revision codes. Analyses were stratified by injury severity score greater than or equal to 15. Annual trends were modeled using generalized linear models. Survey-adjusted logistic regression was used to compare the odds for in-hospital mortality, and the average marginal effects were calculated to compare the cost of hospitalization with and without sepsis. MEASUREMENTS AND MAIN RESULTS: There were 320,450 (SE = 3,642) traumatic injury discharges from U.S. hospitals with sepsis between 2012 and 2016, representing 6.0% (95% CI, 5.9-6.0%) of the total trauma population (n = 5,329,714; SE = 47,447). In-hospital mortality associated with sepsis after trauma did not change over the study period (p > 0.40). In adjusted analysis, severe (injury severity score ≥ 15) and nonsevere injured septic patients had an odds ratio of 1.39 (95% CI, 1.31-1.47) and 4.32 (95% CI, 4.06-4.59) for in-hospital mortality, respectively. The adjusted marginal cost for sepsis compared with nonsepsis was $16,646 (95% CI, $16,294-$16,997), and it was greater than the marginal cost for severe injury compared with nonsevere injury $8,851 (95% CI, $8,366-$8,796). CONCLUSIONS: While national trends for sepsis mortality have improved over the years, our analysis of National Inpatient Sample did not support this trend in the trauma population. The odds risk for death after sepsis and the cost of care remained high regardless of severity of injury. More rigor is needed in tracking sepsis after trauma and evaluating the effectiveness of hospital mandates and policies to improve sepsis care in patients after trauma.

Disparities in Benign Prostatic Hyperplasia Progression: Predictors of Presentation to the Emergency Department in Urinary Retention.

PURPOSE: This retrospective cohort study evaluates the characteristics of patients who presented to the emergency department with acute urinary retention. MATERIALS AND METHODS: Using the Healthcare Cost and Utilization Project State Emergency Department Databases we conducted a retrospective cohort study of patients who presented to emergency departments in Florida between 2005 and 2015. Male patients age 45 years or older who presented with diagnosis codes for acute urinary retention and lower urinary tract symptoms/benign prostatic hyperplasia were considered. Information was collected on age, race/ethnicity, primary insurance and rural-urban commuting area codes. RESULTS: The mean age for males presenting with acute urinary retention was 72.2 years, which was 10.6 years older than those presenting for nonurological complaints (p <0.001). Multivariable analysis adjusted for measured confounders found all covariates to be significant. The risk of presenting to the emergency department for acute urinary retention from lower urinary tract symptoms/benign prostatic hyperplasia increased with age, with the 75 to less than 85-year-old age group at the highest risk (OR 15.96, p <0.001). Other factors associated acute urinary retention included African American (OR 1.15, p <0.001) or Hispanic (OR 1.75, p <0.001) race, Medicare (OR 1.27, p <0.001) or private (OR 1.33, p <0.001) insurance, and urban rural-urban commuting area codes (OR 1.31, p <0.001). CONCLUSIONS: Male patients who presented to the emergency department for acute urinary retention with benign prostatic hyperplasia were more likely to be older, of nonwhite race, have Medicare or private insurance, and live in more urban areas. These data suggest that African American and Hispanic patients may be untreated or under treated for benign prostatic hyperplasia in the outpatient setting, resulting in an increased risk of presentation to the emergency department with acute urinary retention.

Use of Surgery for Post-Prostatectomy Incontinence.

PURPOSE: Stress urinary incontinence following radical prostatectomy is common and potentially debilitating. Surgical therapy with a urethral sling or an artificial urinary sphincter is an effective option with high patient satisfaction in men in whom conservative measures fail to treat post-prostatectomy incontinence. We sought to characterize the contemporary utilization of surgical therapy of post-prostatectomy incontinence using an all payer database. MATERIALS AND METHODS: We used the Healthcare Cost and Utilization Project databases for Florida from 2006 to 2015 and identified men who underwent radical prostatectomy between 2006 and 2012 using ICD procedure codes. Patients were tracked longitudinally for placement of an ambulatory or inpatient urethral sling, or an artificial urinary sphincter between 2006 and 2015. Patient and clinical data were extracted and analyzed with descriptive statistics. A multivariable logistic regression model was constructed to determine risk adjusted predictors of subsequent incontinence surgery. RESULTS: During the study period 29,287 men underwent radical prostatectomy, of whom 1,068 (3.6%) were treated with subsequent incontinence surgery a median of 23.5 months after prostatectomy. On multivariate analysis risk factors for incontinence surgery included age groups 61 to 70 years (OR 1.25, p=0.008) and 71 to 80 years (OR 1.34, p=0.022), Medicare insurance (OR 1.33, p <0.005) and an increased Charlson Comorbidity Index (OR 1.13 per unit increase, p <0.005). CONCLUSIONS: Of patients who underwent radical prostatectomy 3.6% subsequently underwent stress urinary incontinence surgery. Post-prostatectomy incontinence surgery is likely under performed and delayed in performance based on the previously reported prevalence of severe post-prostatectomy incontinence and the natural history of symptoms. Efforts to increase prompt repair of refractory or severe incontinence can greatly improve patient quality of life after radical prostatectomy.

Penile Prosthesis Implantation and Timing Disparities After Radical Prostatectomy: Results From a Statewide Claims Database.

BACKGROUND: Many patients with erectile dysfunction (ED) after radical prostatectomy (RP) improve with conservative therapy but some do not; penile prosthesis implantation rates have been sparsely reported, and have used nonrepresentative data sets. AIM: To characterize rates and timing of penile prosthesis implantation after RP and to identify predictors of implantation using a more representative data set. METHODS: The Healthcare Cost and Utilization Project State Inpatient and State Ambulatory Surgery databases for Florida from 2006 to 2015 were used. Patients undergoing RP (2006-2012) were tracked longitudinally for penile prosthesis implantation. Patient and clinical data were analyzed using multivariable logistic regression. OUTCOMES: The primary outcome was risk-adjusted predictors of prosthesis implantation, and the secondary outcome was predictors of the highest quartile of time between RP and penile prosthesis. RESULTS: Of 29,288 men who had RP, 1,449 (4.9%) patients underwent subsequent prosthesis. The mean time from RP to prosthesis was 2.6 years (median: 2.1; interquartile range [IQR]: 1.2-3.5). Adjusted predictors of prosthesis implantation included open RP (odds ratio [OR]: 1.5, P < .01), African American race (OR: 1.7, P < .01) or Hispanic ethnicity (OR: 3.2, P < .01), and Medicare (OR: 1.4, P < .01) insurance. Oler patients (age >70 years; OR: 0.7, P < .01) and those from the highest income quartile relative to the lowest (OR: 0.8, P < .05) were less likely to be implanted. Adjusted predictors of longer RP-to-implantation time (highest quartile: median: 4.7 years; IQR: 3.9-6.0 years) included open RP (OR: 1.78, P < .01), laparoscopic RP (OR: 4.67, P < .01), Medicaid (OR: 3.03, P < .05), private insurance (OR: 2.57, P < .01), and being in the highest income quartile (OR: 2.52, P < .01). CLINICAL IMPLICATIONS: These findings suggest ED treatment healthcare disparities meriting further investigation; upfront counseling on all ED treatment modalities and close monitoring for conservative treatment failure may reduce lost quality of life years. STRENGTHS & LIMITATIONS: This study is limited by its use of administrative data, which relies on accurate coding and lacks data on ED questionnaires/prior treatments, patient-level cost, and oncologic outcomes. Quartile-based analysis of income and time between RP and prosthesis limits the conclusions that can be drawn. CONCLUSION: Less than 5% of post-RP patients undergo penile prosthesis implantation, with open RP, Medicare, African American race, and Hispanic ethnicity predicting post-RP implantation; living in the wealthiest residential areas predicts lower likelihood of implantation compared to the least wealthy areas. Patients with the longest time between RP and prosthesis are more likely to live in the wealthiest areas or have undergone open/laparoscopic RP relative to robotic RP. Bajic P, Patel PM, Nelson MH, et al. Penile Prosthesis Implantation and Timing Disparities After Radical Prostatectomy: Results From a Statewide Claims Database. J Sex Med 2020;17:1175-1181.

Assessment of textbook oncologic outcomes following pancreaticoduodenectomy for pancreatic adenocarcinoma.

BACKGROUND: Composite outcomes may more accurately reflect patient and provider expectations around optimal care. We sought to determine the impact of achieving a so-called "textbook oncologic outcome" (TOO) among patients undergoing resection of pancreatic adenocarcinoma (PDAC). METHODS: Patients undergoing pancreaticoduodenectomy (PD) for PDAC between 2006 and 2016 were identified in the National Cancer Database (NCDB). TOO was defined by: margin negative resection, compliant lymph node evaluation, no prolonged length-of-stay, no 30-day readmission/mortality, and receipt of adjuvant chemotherapy. Factors associated with TOO and overall survival (OS) were evaluated using multivariable logistic and Cox regression models, respectively. RESULTS: Among 18 608 patients who underwent PD at 782 hospitals, many patients successfully achieved certain TOO factors such as R0 margin (77.9%) and no 30-day mortality (96.9%), while other TOO criteria such as receipt of adjuvant therapy (48.2%) were achieved less frequently. Overall, only 3124 (16.8%) patients achieved a TOO. Factors associated with lower odds of TOO included: older age, Black race, Medicaid insurance, Community facility, and low PD facility (<20 PD/y) (all P < .05). Achievement of a TOO was associated with lower risk of mortality (HR 0.74; 95% CI, 0.70-0.77). CONCLUSIONS: While TOO was associated with improved long-term survival, TOO was only achieved in 16.8% of patients undergoing PD.

The Impact of the Affordable Care Act Medicaid Expansion on Vascular Surgery.

BACKGROUND: The Affordable Care Act (ACA) Medicaid expansion increased Medicaid eligibility such that all adults with an income level up to 138% of the federal poverty threshold in 2014 qualified for Medicaid benefits. Prior studies have shown that the ACA Medicaid expansion was associated with increased access to care. The impact of the ACA Medicaid expansion on patients undergoing complex care for major vascular pathology has not been evaluated. METHODS: The Healthcare Cost and Utilization Project State Inpatient Database was used to identify patients undergoing care for major vascular pathology in 6 states from 2010 to 2014. The analysis cohort included adult patients between the ages of 18 and 64 years who underwent a nonemergent surgical procedure for an abdominal aortic aneurysm, thoracic aortic aneurysm, carotid artery stenosis, peripheral vascular disease, or chronic kidney disease. Poisson regression was used to determine the incidence rate ratios (IRRs). RESULTS: There were a total of 83,960 patients in the study cohort. Compared with nonexpansion states, inpatient admissions for Medicaid patients with an abdominal or thoracic aneurysm and carotid stenosis diagnosis increased significantly (IRR, 1.20, 1.27, 1.06, respectively; P < 0.05) in states that expanded Medicaid. Vascular-related surgeries increased for carotid endarterectomy, lower extremity revascularization, lower extremity amputation, and arteriovenous fistula in expansion states (IRR, 1.24, 1.10, 1.11, 1.16, respectively; P < 0.05) compared with nonexpansion states. CONCLUSIONS: In states that expanded Medicaid coverage under the ACA, the rate of vascular-related surgeries and admissions for Medicaid patients increased. We conclude that expanding insurance coverage results in enhanced access to vascular surgery.

Risk stratification for postoperative pancreatic fistula using the pancreatic surgery registry StuDoQ|Pancreas of the German Society for General and Visceral Surgery.

BACKGROUND: Postoperative pancreatic fistula (POPF) is a major factor for morbidity and mortality after pancreatic resection. Risk stratification for POPF is important for adjustment of treatment, selection of target groups in trials and quality assessment in pancreatic surgery. In this study, we built a risk-prediction model for POPF based on a large number of predictor variables from the German pancreatic surgery registry StuDoQ|Pancreas. METHODS: StuDoQ|Pancreas was searched for patients, who underwent pancreatoduodenectomy from 2014 to 2016. A multivariable logistic regression model with elastic net regularization was built including 66 preoperative und intraoperative parameters. Cross-validation was used to select the optimal model. The model was assessed via area under the ROC curve (AUC) and calibration slope and intercept. RESULTS: A total of N = 2488 patients were included. In the optimal model the predictors selected were texture of the pancreatic parenchyma (soft versus hard), body mass index, histological diagnosis pancreatic ductal adenocarcinoma and operation time. The AUC was 0.70 (95% CI 0.69-0.70), the calibration slope 1.67 and intercept 1.12. In the validation set the AUC was 0.65 (95% CI 0.64-0.66), calibration slope and intercept were 1.22 and 0.42, respectively. CONCLUSION: The model we present is a valid measurement instrument for POPF risk based on four predictor variables. It can be applied in clinical practice as well as for risk-adjustment in research studies and quality assurance in surgery.

Wound protectors mitigate superficial surgical site infections after pancreatoduodenectomy.

BACKGROUND: Whether the choice of antibiotic prophylaxis, the type of incision, or the use of wound protectors decreases surgical site infections (SSIs) in patients undergoing pancreatoduodenectomy (PD) remains unknown. METHODS: Patients undergoing open, elective PD between January 1, 2016 and June 30, 2017 were identified from the American College of Surgeons' National Surgical Quality Improvement Program registry. Multivariable logistic regression models were constructed to determine the association of antibiotic prophylaxis type, incision type, and wound protector use on the incidence of any, superficial, and organ/space SSIs, and to profile hospitals. RESULTS: Overall, 5969 patients were included from 140 hospitals. The overall rate of SSI was 20.3% (n = 1213). Superficial SSIs occurred in 432 (7.2%) patients and organ/space SSIs in 841 (14.1%). Wound protector use was associated with 23% lower odds of experiencing any SSIs (OR 0.77, 95% CI 0.60-0.98), reflective of the decreased odds associated with superficial SSIs (OR 0.65, 95% CI 0.44-0.97), but not organ/space SSIs (OR 0.89, 95% CI 0.68-1.17). Highest-performing hospitals frequently utilized broad-spectrum antibiotics, midline incisions, and wound protectors. CONCLUSION: Wound protectors reduced superficial, but not organ/space, infections in patients undergoing pancreatoduodenectomy. Routine use of wound protectors in patients undergoing proximal pancreatectomy is recommended.

Primary systemic therapy in resectable pancreatic ductal adenocarcinoma using mFOLFIRINOX: A pilot study.

BACKGROUND AND OBJECTIVES: Surgery followed by gemcitabine and/or a fluoropyrimidine is standard therapy for resectable PDAC. mFOLFIRINOX (oxaliplatin 85 mg/m2 , irinotecan 180 mg/m2 , leucovorin 400 mg/m2 Day 1, 5-FU 2400 mg/m2 × 48 h IV, peg-filgrastim 6 mg SQ day 3, every 14 days) has substantial activity in metastatic PDAC. We wished to determine the tolerability/efficacy of peri-operative mFOLFIRINOX in resectable PDAC. METHODS: Patients with resectable PDAC (ECOG PS 0/1) received four cycles of mFOLFIRINOX pre- and post-surgery. The primary endpoint was completion of preoperative chemotherapy plus resection. Secondary endpoints included completion of all therapy, R0 resection, treatment related toxicity, PFS, and OS. RESULTS: Twenty-one patients enrolled: median age 62 (47-78); 20/21 (95%) completed four cycles of preoperative mFOLFIRINOX; response by RECIST was 1 CR, 3 PR, 16 SD; 17/21 (81%) completed resection, 16/21 (76%) R0; 14/21 (66%) completed four cycles of postoperative mFOLFIRINOX. Grade 3 and 4 toxicity occurred in 23% and 14% patients pre-operatively, 26% and 6.0% post-operatively. Nine patients are alive with median follow-up of 27.7 (3.1-47.1) months. CONCLUSIONS: PST using mFOLFIRINOX in resectable PDAC is feasible and tolerable. R0 resection rate is high and survival promising, requiring longer follow-up and larger studies for definitive assessment.

The extent of vascular resection is associated with perioperative outcome in patients undergoing pancreaticoduodenectomy.

BACKGROUND: Few studies have examined the relation between extent of vascular resection and morbidity following pancreaticoduodenectomy (PD) with vein resection (PDVR). METHODS: Patients undergoing PD for malignancy were identified using the American College of Surgeons National Surgical Quality Improvement Project from 2006 to 2013. Current procedural terminology codes were used to characterize PDVR. RESULTS: 9235 patients underwent PD, 977 (10.6%) had PDVR - 640 with direct and 224 with graft repair. PDVR had longer operative times (456 ± 136 vs 374 ± 128 min, p < 0.05) and higher intraoperative transfusions (1.8 ± 3.4 vs 4.3 ± 4.9 units, p < 0.05) than PD alone. On adjusted multivariable regression, PDVR with either direct or graft repairs was associated with higher rates of overall morbidity (OR [odds ratio] 1.50 for direct, 1.74 for graft, p < 0.05), bleeding (OR 2.18 for direct, 3.26 for graft, p < 0.05), and DVT (OR 2.12 for direct, 2.62 for graft, p < 0.05) compared to PD alone. Graft repair was further associated with increased risk of reoperation (OR 1.59), septic shock (OR 2.77) and 30-day mortality (OR 2.72), all p < 0.05. DISCUSSION: The risk of significant morbidity and mortality for PDVR is associated with the extent of vascular resection, with graft repairs having increased morbidity and mortality rates.

Adjuvant Therapy Improves Survival for T2N0 Gastric Cancer Patients with Sub-optimal Lymphadenectomy.

BACKGROUND: The benefit of adjuvant therapy following resection of early stage, node-negative gastric adenocarcinoma following a margin negative (R0) resection is unclear. METHODS: The National Cancer Data Base was used to identify patients with a T2N0 gastric adenocarcinoma (tumor invasion into the muscularis propria) who underwent R0 resection. Patients treated with neoadjuvant therapy and those for whom lymph node count was unavailable were excluded from the analysis. Kaplan-Meier and Cox regression were used to evaluate differences in and predictors of overall survival. RESULTS: A total of 1687 patients underwent R0 resection for T2N0 gastric adenocarcinoma between 2003-2011. Adjuvant chemotherapy treatment was administered to 7.1 and 14.1 % received adjuvant chemoradiation; 65.4 % had <15 lymph nodes examined. Multivariate Cox regression identified higher Charlson score, <15 lymph nodes examined, higher tumor grade, and tumor location in the cardia as factors associated with significantly decreased overall survival. With a median follow-up of 36 months, the 5-year overall survival was 71 % for patients with ≥15 lymph nodes examined and 53 % for those with <15 lymph nodes (p < 0.001). In patients who had <15 lymph nodes examined, there was an overall survival benefit for adjuvant chemoradiation (hazard ratio 0.71, p = 0.043). In patients with ≥15 lymph nodes examined, no survival benefit for adjuvant therapy was identified (p > 0.74). CONCLUSIONS: Adequate lymph node dissection and pathologic staging is critical in directing optimal treatment of patients with early gastric cancer. Understaging as a result of suboptimal lymphadenectomy may explain the perceived benefit of adjuvant chemoradiation after an R0 resection for T2N0 gastric cancer.

Hepatocellular Carcinoma: Surgical Management and Evolving Therapies.

HCC is the second leading cause of cancer death worldwide. The majority of cases arise within the background of liver cirrhosis and are most commonly related to chronic hepatitis B and C viral infection. Surgical resection, liver transplantation, and tumour ablation are potentially curative modalities in cases of localized, non-metastatic, hepatocellular carcinoma. Systemic sorafenib has been shown to be marginally effective in slow disease progression in patients whose cirrhosis is so severe that they are not candidates for liver directed therapy and in those with metastatic disease. Several large prospective and retrospective studies have demonstrated transplantation to provide better long term outcomes than resection in patients with small volume carcinoma. Other small retrospective series have demonstrated similar outcomes for patients with well matched tumour characteristics and compensated cirrhosis. There is not even level one evidence to guide the choice of modality to be used in individual cases and treatment algorithms vary widely among high volume centres. Newer and emerging techniques and approaches such as laparoscopic liver resection and living donor transplantation continue to evolve and impact choice of treatment in absence of well-controlled comparative trials. For locally advanced disease and in patients with significant cirrhosis, interventional technologies such as transarterial chemoembolization or transarterial radioembolization can provide disease control or result in tumour regression and hypertrophy in the future liver remnant and may allow interval resection or down-staging to liver transplantation. Improving transarterial, surgical, and transplant techniques continue to expand the surgical and interventional options for managing localized HCC and are driving a shift towards aggressive multimodality therapy in patients with localized hepatoma.

Defining the Benefit of Adjuvant Therapy Following Resection for Intrahepatic Cholangiocarcinoma.

BACKGROUND: Intrahepatic cholangiocarcinoma (ICC) is rare but is increasing in incidence. While hepatectomy can be curative, the benefit of adjuvant therapy (AT) remains unclear. We utilized the National Cancer Data Base (NCDB) to isolate predictors of overall survival, describe the national pattern of AT administration, and identify characteristics of patients who experience a survival benefit from AT following resection for ICC. METHODS: Patients who were diagnosed with ICC between 1998 and 2006 and underwent surgical resection were identified through the NCDB. Kaplan-Meier and Cox regression analyses evaluated differences in overall survival between patients who received AT and those who did not. RESULTS: Overall, 638 patients who underwent surgery for ICC were identified. Multivariate Cox regression analysis identified positive lymph nodes, unexamined lymph nodes, positive margins, and lack of AT as predictors of decreased overall survival; 28.1 % of patients had positive margins while 20.1 % had positive nodes. These patients, as well as those who were younger and had fewer co-morbid conditions, were most likely to receive AT. After adjusting for other prognostic variables, patients were found to significantly benefit from AT if they had positive lymph nodes [chemotherapy: hazard ratio (HR) 0.54, p = 0.0365; chemoradiation: HR 0.50, p = 0.005] or positive margins (chemotherapy: HR 0.44, p = 0.0016; chemoradiation: HR 0.57, p = 0.0039). CONCLUSIONS: Positive lymph nodes and positive margins were associated with poor survival after resection for ICC. After controlling for other prognostic factors, AT was associated with significant survival benefits among patients with positive nodes or positive margins.

Using a modification of the Clavien-Dindo system accounting for readmissions and multiple interventions: defining quality for pancreaticoduodenectomy.

BACKGROUND: The Clavien-Dindo system (CD) does not change the grade assigned a complication when multiple readmissions or interventions are required to manage a complication. We apply a modification of CD accounting for readmissions and interventions to pancreaticoduodenectomy (PD). METHODS: PDs done between 1999 and 2009 were reviewed. CD grade IIIa complications requiring more than one intervention and II and IIIa complications requiring significantly prolonged lengths of stay including all 90-day readmissions were classified severe-adverse-postoperative-outcomes (SAPO). CD IIIb, IV, and V complications were also classified SAPOs. All other complications were considered minor-adverse-postoperative-outcomes (MAPO). RESULTS: Four-hundred forty three of 490 PD patients (90.4%) had either no complication or a complication of low to moderate CD grade (I, II, IIIa). When reclassified by the new metric, 92 patient-outcomes (19%) were upgraded from CD II or IIIa to SAPO. One-hundred thirty nine patients (28.4%) had a SAPO. Multivariable regression identified age >75 years, pylorus preservation and operative blood loss >1,500 ml as predictors of SAPO. Age was not associated with poor outcome using the unmodified CD system. CONCLUSIONS: Established systems may under-grade the severity of some complications following PD. We define a procedure-specific modification of CD accounting for readmissions and multiple interventions. Using this modification, advanced age, pylorus preservation, and significant blood loss are associated with poor outcome.

Association between COVID-19 diagnosis and postoperative outcomes in sleeve gastrectomy and Roux-en-Y gastric bypass: A national cohort study.

BACKGROUND: We seek to determine the association between COVID-19 diagnosis and postoperative outcomes following bariatric surgery. METHODS: Using the Metabolic and Bariatric Surgery Accreditation Quality Improvement Project (MBSAQIP) database, patients undergoing sleeve gastrectomy and gastric bypass without a COVID-19 diagnosis were 2:1 propensity-score matched to those with COVID-19 infection pre or postoperatively. RESULTS: 1369 (0.74 â€‹%) and 1331 (0.72 â€‹%) patients had a COVID-19 diagnosis within 14 days prior to or 30 days after their operation, respectively. Patients with preoperative COVID-19 infection had equivalent outcomes to COVID-19 negative patients (all p â€‹> â€‹0.05). Postoperative COVID-19 diagnosis was associated with worse outcomes including increased risk of anastomotic/staple line leak (1.1 â€‹% vs 0.1 â€‹%, p â€‹< â€‹0.001), postoperative pneumonia (2.9 â€‹% vs 0.1 â€‹%, p â€‹< â€‹0.001), and 30-day reoperation (2.1 â€‹% vs 0.9 â€‹%, p â€‹= â€‹0.002). CONCLUSIONS: Postoperative diagnosis of COVID-19 after bariatric surgery is associated with worse outcomes; however, it is safe to perform these procedures on patients recently convalesced from COVID-19 infection.

Fragmented care, Commission on Cancer accreditation, and overall survival in patients receiving surgery and chemotherapy for esophageal cancer.

BACKGROUND: Increasing regionalization for esophagectomy for cancer may lead patients to travel for surgery at one institution and receive chemotherapy at another closer to home. We explore the effects on survival for care fragmentation, the Commission on Cancer status of secondary institutions providing chemotherapy, and the type of institution performing surgery. METHODS: We queried the National Cancer Database to identify all patients who underwent esophagectomy for esophageal cancer and received perioperative chemotherapy between 2006 and 2019. Patients were divided into single-center care, fragmented-to-Commission on Cancer care, or fragmented-to-non-Commission on Cancer care. We identified associations using multivariable logistic regression, Kaplan-Meier survival analyses, and Cox proportional hazards models. RESULTS: A total of 18,502 patients met the criteria for inclusion: 8,290 (44.8%) received single-center care; 3,414 (18.5%) fragmented-to-Commission on Cancer care; and 6,798 (36.4%) fragmented-to-non-Commission on Cancer care. Fragmented care was more likely in White patients (adjusted odds ratio = 1.25; P < .001) and in patients nonadjacent to a metropolitan area (adjusted odds ratio = 1.36; P < .001). Overall survival was equivalent between single-center and fragmented care, but undergoing an esophagectomy at an academic center was associated with improved survival (adjusted hazard ratio = 0.82; P = .016). In patients with an esophagectomy at a nonacademic center, overall survival was best if perioperative chemotherapy was administered at Commission on Cancer-accredited facilities compared with chemotherapy at fragmented-to-non-Commission on Cancer centers (P = .022). CONCLUSION: Most of the esophageal cancer care in the US is fragmented at multiple institutions. When care is fragmented, it is most commonly at non-Commission on Cancer centers for perioperative chemotherapy. Overall survival is best when esophagectomy is performed at an academic center, and perioperative therapy is administered at Commission on Cancer-accredited facilities.