Molecular targeted and systemic therapy for intrahepatic cholangiocarcinoma: a multi-disciplinary approach.

Most patients with intrahepatic cholangiocarcinoma (ICC) are diagnosed with advanced disease. For individuals with resectable tumors, R0 resection with lymphadenectomy is the best potentially curative-intent treatment. After resection, adjuvant therapy with capecitabine is the current standard of care. For patients with unresectable or distant metastatic disease, doublet chemotherapy with gemcitabine and cisplatin is the most utilized first-line regimen, but recent studies using triplet regimens and even the addition of immunotherapy have begun to shift the paradigm of systemic therapy. Molecular therapies have recently received US FDA approval for second-line treatment for patients harboring actionable genomic alterations. This review focuses on the multidisciplinary approach to the treatment of ICC with an emphasis on molecular targeted and systemic therapy.

Postoperative Liver Failure: Definitions, Risk factors, Prediction Models and Prevention Strategies.

BACKGROUND: Liver resection is the treatment for a variety of benign and malignant conditions. Despite advances in preoperative selection, surgical technique, and perioperative management, post hepatectomy liver failure (PHLF) is still a leading cause of morbidity and mortality following liver resection. METHODS: A review of the literature was performed utilizing MEDLINE/PubMed and Web of Science databases in May of 2023. The MESH terms "liver failure," "liver insufficiency," and "hepatic failure" in combination with "liver surgery," "liver resection," and "hepatectomy" were searched in the title and/or abstract. The references of relevant articles were reviewed to identify additional eligible publications. RESULTS: PHLF can have devastating physiological consequences. In general, risk factors can be categorized as patient-related, primary liver function-related, or perioperative factors. Currently, no effective treatment options are available and the management of PHLF is largely supportive. Therefore, identifying risk factors and preventative strategies for PHLF is paramount. Ensuring an adequate future liver remnant is important to mitigate risk of PHLF. Dynamic liver function tests provide more objective assessment of liver function based on the metabolic capacity of the liver and have the advantage of easy administration, low cost, and easy reproducibility. CONCLUSION: Given the absence of randomized data specifically related to the management of PHLF, current strategies are based on the principles of management of acute liver failure from any cause. In addition, goal-directed therapy for organ dysfunction, as well as identification and treatment of reversible factors in the postoperative period are critical.

Quality of Care Among Medicare Patients Undergoing Pancreatic Surgery: Safety Grade, Magnet Recognition, and Leapfrog Minimum Volume Standards-Which Quality Benchmark Matters?

BACKGROUND: The association of national quality benchmarking metrics with postoperative outcomes following complex surgery remains unknown. We assessed the relationship between the "quality trifactor" of Leapfrog minimum volume standards, Hospital Safety Grade A, and Magnet Recognition with outcomes of Medicare patients undergoing pancreatectomy. METHODS: The Standard Analytic Files (SAF) merged with Leapfrog Hospital Survey and Leapfrog Safety Scores Denominator Files were reviewed to identify Medicare patients who underwent pancreatic procedures between 2013 and 2015. Primary outcomes were overall and serious complications, as well as 30- and 90-day mortality. Multivariable logistic regression analyses were conducted to evaluate possible associations among hospitals meeting the quality trifactor and short-term outcomes. RESULTS: Among 4853 Medicare patients, 909 (18.7%) underwent pancreatectomy at hospitals meeting the quality trifactor. Among 260 hospitals, 7.3% (n = 19) met the quality trifactor. Safety Grade A (48.8%, n = 127) was the most commonly met criterion followed by Magnet Recognition (36.2%, n = 94); the Leapfrog minimum volume standards were achieved by 25% (n = 65) of hospitals. Patients undergoing surgery at hospitals that were only Safety Grade A and Magnet designated, but did not meet Leapfrog criteria, had higher odds of serious complications (OR 1.59, 95% CI 1.00-2.51). In contrast, patients undergoing treatment at hospitals having all three designations (i.e., the quality trifactor) had 40% and 39% lower odds of both serious complications (OR 0.60, 95% CI 0.37-0.97) and 90-day mortality (OR 0.61, 95% CI 0.42-0.89), respectively. In turn, patients undergoing pancreatectomy at quality trifactor hospitals had higher odds of experiencing the composite quality measure textbook outcome (OR 1.28, 95% CI 1.03-1.59) versus patients undergoing pancreatectomy at non-trifactor hospitals. CONCLUSION: While Safety Grade A and Magnet designation alone were not associated with higher odds of an optimal composite outcome following pancreatectomy, compliance with Leapfrog criteria to achieve the "quality trifactor" metric was associated with lower odds of serious complications and mortality.

Inside the courtroom: An analysis of malpractice litigation in gallbladder surgery.

BACKGROUND: Cholecystectomy is one of the most commonly performed operations in the United States, yet it still carries up to a 6% risk of major morbidity. Lawsuits are a major source of emotional, financial, and personal stress for surgeons. We sought to characterize malpractice claims associated with gallbladder surgery as well as define contributing factors and costs with these claims. METHODS: The Westlaw database (Thomson Reuters Corporation, Toronto, Canada) was queried for jury verdicts and settlements related to cholecystectomy and malpractice between 2000 and 2018. Data were abstracted from the case files and details of the settlements, jury verdicts, and factors related to the claims were assessed. RESULTS: Among 231 cases, a plaintiff verdict was reached in 45 (19.5%) and a defendant verdict was reached in 122 (53%); other cases were either settled (n = 29, 12%), dismissed (n = 31, 13%), or denied (n = 4, 2%). Plaintiff cases often involved young (median age, 44 years [interquartile range: 35-57]) female (n = 146, 63%) patients. The attending surgeon accounted for 59% of defendants. Procedural error (49%), wrongful death (18%), or failure to treat in a timely manner (13%) were the most commonly cited reasons for litigation. Among the 134 cases where a second surgical procedure was performed, the most common types of procedures were biliary tract repair (n = 82, 61%) and bowel repair (n = 16, 12%). The total cost of the claims over the study period was $22 million with a median payout of $500,000; the median time from operative event to final disposition was over 5 years (interquartile range: 4-7). CONCLUSION: A plaintiff verdict or settlement was reached in 1 in 3 cases, and large payouts were common. Minimizing procedural error and improving care of patients after cholecystectomy complications should be emphasized.

Immunotherapy utilization for hepatobiliary cancer in the United States: disparities among patients with different socioeconomic status.

BACKGROUND: Patients with advanced hepatobiliary cancer (HBC) have a dismal prognosis and limited treatment options. Immunotherapy has been considered as a promising treatment, especially for cancers not amenable to surgery. METHODS: Between 2004, and 2015, patients diagnosed with hepatocellular carcinoma (HCC), intra- and extrahepatic cholangiocarcinoma and gallbladder cancer (GBC) were identified in the National Cancer Database. RESULTS: Among 249,913 patients with HBC, only 585 (0.2%) patients received immunotherapy. Among patients who received immunotherapy, most patients were diagnosed between 2012 and 2015, had private insurance, as well as an income ≥$46,000 and were treated at an academic facility. The use of immunotherapy among HBC patients varied by diagnosis (HCC, 67.7%; bile duct cancer, 14%). On multivariable analysis, a more recent period of diagnosis (OR 1.80, 95% CI: 1.44-2.25), median income >$46,000 (OR 1.43, 95% CI: 1.11-1.87), and higher tumor stage (stage III, OR 2.22, 95% CI: 1.65-3.01; stage IV, OR 3.24, 95% CI: 2.41-4.34) were associated with greater odds of receiving immunotherapy. CONCLUSIONS: Overall utilization of immunotherapy in the US among patients with HBC was very low, yet has increased over time. Certain socioeconomic factors were associated with an increased likely of receiving immunotherapy, suggesting disparities in access of patients with lower socioeconomic status.

Hospital variation in Textbook Outcomes following curative-intent resection of hepatocellular carcinoma: an international multi-institutional analysis.

BACKGROUND: Composite measures such as "Textbook Outcome" (TO) may be superior to individual quality metrics to assess surgical care and hospital performance. However, the incidence and factors associated with TO after resection of HCC remain poorly defined. METHODS: Hospital variation in the rates of TO, factors associated with achieving a TO and the impact of TO on long-term survival following resection for HCC were examined using an international multi-institutional database. RESULTS: Among 605 patients who underwent curative-intent resection of HCC, the unadjusted incidence of TO ranged from 50.9% to 77.7%. While achievement of each individual quality metric was relatively high (range, 74.5-98.0%), an overall TO was achieved among only 62.3% (n = 377) of patients. At the hospital level, TO ranged from 54.3% to 72.9%. Patients with BCLC-0 HCC (referent BCLC-B/C; OR: 4.17, 95%CI: 1.62-10.7) and ALBI grade 1 (referent ALBI grade 2/3; OR: 1.49, 95%CI: 1.06-2.11) had higher odds of achieving a TO. On multivariable analysis, TO was associated with improved overall survival (HR: 0.60, 95% CI: 0.42-0.85). CONCLUSION: Roughly 6 in 10 patients achieved a TO following resection for HCC. When achieved, TO was associated with better long-term outcomes. TO is a simple composite measure of both short- and long-term outcomes among patients undergoing resection for HCC.

In-hospital Mortality Following Pancreatoduodenectomy: a Comprehensive Analysis.

BACKGROUND: While patient- and hospital-level factors affecting outcomes of patients undergoing pancreatoduodenectomy (PD) have been well described separately, the relative impact of these factors on in-hospital mortality has not been comprehensively assessed. METHODS: Retrospective review of the National Inpatient Sample database (January 2004-December 2014) was conducted to identify patients undergoing PD. Factors associated with in-hospital mortality after PD were analyzed after adjusting for previously defined patient- and hospital-level risk factors. RESULTS: A total of 9639 patients who underwent a PD at 2325 hospitals were identified. Median patient age was 57 years (IQR 66-73). Overall, mortality following PD was 3.2%. When patient- and hospital-level characteristics were analyzed in the same model, patient-level characteristic associated with increased odds of in-hospital mortality included increasing patient age (OR 1.05, 95% CI 1.03-1.06/per 5 years increase), male sex (OR 1.47, 95% CI 1.16-1.86), the presence of liver disease (OR 3.03, 95% CI 1.99-4.61), chronic kidney disease (OR 1.78, 95% CI 1.18-2.68), and congestive heart failure (OR 2.48, 95% CI 1.65-3.74). The only hospital characteristic associated with odds of mortality following PD included compliance with Leapfrog volume standards (OR 0.70, 95% CI 0.54-0.92). CONCLUSION: Patient-level factors, such as advanced comorbidities, male sex, and increased age, contributed the most to increased risk of mortality after PD. Hospital volume was the only hospital-level factor contributing to risk of in-hospital mortality following PD.

Short-Term Outcomes of Patients Undergoing Portal Vein Embolization: an ACS-NSQIP Procedure-Targeted Hepatectomy Analysis.

BACKGROUND: Preoperative portal vein embolization (PVE) is utilized to induce growth of the future liver remnant volume (FLRV) among patients at elevated risk of post-hepatectomy liver failure (PHLF). METHODS: The American College of Surgery National Surgical Quality Improvement Program (ACS-NSQIP) database was used to compare short-term outcomes of PVE versus non-PVE patients. A propensity score match (PSM) was used to compare short-term outcomes among PVE and non-PVE patients. RESULTS: Among the 11,243 patients included in the study, 462 (4.1%) patients had a PVE. Postoperatively, patients who underwent PVE had a higher incidence of overall (PVE, 44% vs. non-PVE, 23%) and liver-specific complications (biliary leak PVE, 16% vs. non-PVE, 7%; post-hepatectomy liver failure [PHLF] PVE, 17% vs. non-PVE, 5%), as well as a longer length of stay (> 7 days PVE, 39% vs. non-PVE, 22%) compared with the non-PVE group (all p < 0.001). After PSM, no differences in mortality or LOS were observed among PVE and non-PVE patients. PVE patients remained more likely to have a bile leak, organ/surgical-site infection, and PHLF versus non-PVE patients (all p < 0.05). CONCLUSION: Among patients who underwent PVE before hepatectomy, the risk of postoperative complications was 1.6-fold higher than non-PVE patients. After PSM, PVE patients still had an increased risk of complications.

Impact of Surgeon Volume on Outcomes and Expenditure Among Medicare Beneficiaries Undergoing Liver Resection: the Effect of Minimally Invasive Surgery.

BACKGROUND: Although the role of annual surgeon volume on perioperative outcomes after liver resection (LR) has been investigated, there is a paucity of data regarding the impact of surgeon volume on outcomes of minimally invasive LR (MILR) versus open LR (OLR). METHODS: Patients undergoing LR between 2013 and 2015 were identified in the Medicare inpatient Standard Analytic Files. Patients were classified into three groups based on surgeons' annual caseload: low (≤ 2 cases), medium (3-5 cases), or high (≥ 6 cases). Short-term outcomes and expenditures of LR, stratified by surgeon volume and minimally invasive surgery (MIS), were examined. RESULTS: Among 3403 surgeons performing LR on 7169 patients, approximately 90% of surgeons performed less than 5 liver resections per year for Medicare patients. Only 7.1% of patients underwent MILR (n = 506). After adjustment, the likelihood of experiencing a complication and death within 90 days decreased with increasing surgeon volume. Outcomes of open and MILR among low- or high-volume surgeon groups, including rates of complications, 30- and 90-day readmission and mortality were similar. However, the difference of average total episode payment between open and MIS was higher in the high-volume surgeon group (low volume: $2929 vs. medium volume: $2333 vs. high volume: $7055). CONCLUSION: Annual surgeon volume was an important predictor of outcomes following LR. MILR had comparable results to open LR among both the low- and high-volume surgeons.

Evaluation of the ACS NSQIP Surgical Risk Calculator in Elderly Patients Undergoing Hepatectomy for Hepatocellular Carcinoma.

BACKGROUND: The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) surgical risk calculator (SRC) aims to help predict patient-specific risk for morbidity and mortality. The performance of the SRC among an elderly population undergoing curative-intent hepatectomy for hepatocellular carcinoma (HCC) remains unknown. METHODS: Patients > 70 years of age who underwent hepatectomy for HCC between 1998 and 2017 were identified using a multi-institutional international database. To estimate the performance of SRC, 12 observed postoperative outcomes were compared with median SRC-predicted risk, and C-statistics and Brier scores were calculated. RESULTS: Among 500 patients, median age was 75 years (IQR 72-78). Most patients (n = 324, 64.8%) underwent a minor hepatectomy, while 35.2% underwent a major hepatectomy. The observed incidence of venous thromboembolism (VTE) (3.2%) and renal failure (RF) (4.4%) exceeded the median predicted risk (VTE, 1.8%; IQR 1.5-3.1 and RF, 1.0%; IQR 0.5-2.0). In contrast, the observed incidence of 30-day readmission (7.0%) and non-home discharge (2.5%) was lower than median-predicted risk (30-day readmission, 9.4%; IQR 7.4-12.8 and non-home discharge, 5.7%; IQR 3.3-11.7). Only 57.8% and 71.2% of patients who experienced readmission (C-statistic, 0.578; 95%CI 0.468-0.688) or mortality (C-statistic, 0.712; 95%CI 0.508-0.917) were correctly identified by the model. CONCLUSION: Among elderly patients undergoing hepatectomy for HCC, the SRC underestimated the risk of complications such as VTE and RF, while being no better than chance in estimating the risk of readmission. The ACS SRC has limited clinical applicability in estimating perioperative risk among elderly patients being considered for hepatic resection of HCC.

Minimally Invasive Liver Resection for Early-Stage Hepatocellular Carcinoma: Inconsistent Outcomes from Matched or Weighted Cohorts.

BACKGROUND: The aim of the current study was to re-evaluate the role of minimally invasive liver resection (MILR) among patients with early-stage (stage I or II) hepatocellular carcinoma (HCC) undergoing partial hepatectomy. METHODS: A retrospective analysis of the National Cancer Database (NCDB) was conducted to identify patients with early-stage HCC who underwent partial hepatectomy in the USA from 2010 to 2013. Overall survival (OS) was compared in three cohorts: crude; stabilized inverse probability of treatment propensity score weighting (IPTW); and propensity score matching (PSM). RESULTS: Among 4027 patients included in the study, only 11.7%, (n = 473) underwent MILR. In the stabilized IPTW cohort, patients who underwent MILR versus open resection were more likely to have tumors greater than 3 cm (63.9%, n = 285 vs. 51.4%, n = 228, p < 0.001) and poorly/undifferentiated tumors (21.5%, n = 96 vs. 12.9%, n = 57, p < 0.001). Within the crude cohort, a 5-year OS was superior among patients in the open surgical group (67.8%) compared with patients who underwent MILR (56.6%) (p < 0.001). After classic PSM analysis, the 5-year OS of patients undergoing MILR and open surgery were noted to be comparable (57.3% vs 63.8%, p = 0.17; HR 1.16, 95% CI 0.92-1.45). In contrast, after applying IPTW, the 5-year OS of patients who underwent MILR (55.5%) was worse compared with patients who had an open resection (67.5%) (HR 1.46, 95% CI 1.15-1.84; p < 0.001). CONCLUSIONS: Long-term outcomes of patients undergoing MILR were comparable with patients who had open surgery when assessed by standard PSM. The use of IPTW resulted in more unbalanced groups leading to residual confounding and bias.

Travel to a high volume hospital to undergo resection of gallbladder cancer: does it impact quality of care and long-term outcomes?

BACKGROUND: The relationship of volume and travel distance to patient outcomes after resection of gallbladder cancer (GBC) remains poorly defined. METHODS: The 2004-2015 National Cancer Database was used to identify GBC resection patients and examine the impact of travel distance, hospital volume and both on overall survival (OS) and quality of care indicators. RESULTS: Among 10,174 patients undergoing surgery for GBC, the majority of patients were Caucasian (N = 8,175, 80%) and had a Charlson-Deyo comorbidity score of 0 (N = 6,785, 67%). On unadjusted survival analysis increasing travel distance and hospital volume were associated with improved OS (both p < 0.001). After controlling for competing risk factors, the 4th quartile of hospital volume was associated with a decreased hazard of death (HR 0.831, 95% CI 0.751-0.920, p < 0.001). When both hospital volume and travel distance were included, the association with improved OS persisted only for hospital volume (4th quartile HR 0.835, 95% CI 0.753-0.925, p < 0.001), whereas there was no independent association of increasing travel distance with OS. CONCLUSIONS: Both increasing travel distance and hospital volume were associated with improved OS; however, adjusted models demonstrated that the impact of travel distance was mediated through hospital volume.

Insurance Coverage Type Impacts Hospitalization Patterns Among Patients with Hepatopancreatic Malignancies.

INTRODUCTION: Disparities in health and healthcare access remain a major problem in the USA. The current study sought to investigate the relationship between patient insurance status and hospital selection for surgical care. METHODS: Patients who underwent liver or pancreatic resection for cancer between 2004 and 2014 were identified in the National Inpatient Sample. The association of insurance status and hospital type was examined. RESULTS: In total, 22,254 patients were included in the study. Compared with patients with private insurance, Medicaid patients were less likely to undergo surgery at urban non-teaching hospitals (OR = 0.36, 95%CI 0.22-0.59) and urban teaching hospitals (OR = 0.54, 95%CI 0.34-0.84) than rural hospitals. Medicaid patients were less likely to undergo surgery at private investor-owned hospitals (OR = 0.53, 95%CI 0.38-0.73) than private non-profit hospitals. In contrast, uninsured patients were 2.2-fold more likely to go to government-funded hospitals rather than private non-profit hospitals (OR = 2.19, 95%CI 1.76-2.71). CONCLUSION: Insurance status was strongly associated with the type of hospital in which patients underwent surgery for liver and pancreatic cancers. Addressing the reasons for inequitable access to different hospital settings relative to insurance status is essential to ensure that all patients undergoing pancreatic or liver surgery receive high-quality surgical care.

Skilled nursing facility (SNF) utilization and impact of SNF star-quality ratings on outcomes following hepatectomy among Medicare beneficiaries.

BACKGROUND: An increasing number of patients require admission to a skilled nursing facility (SNF) following surgery. However, the impact of SNF quality on post-operative outcomes is unknown. METHODS: The Medicare Standard Analytic Files and Nursing Home Compare Dataset were used to define SNF utilization and determine the influence of SNF star quality ratings on outcomes following hepatectomy. RESULTS: Among 7256 Medicare beneficiaries, 918 (12.7%) required. Compared to patients discharged home, individuals discharged to SNF were older (median age: 75 [IQR 71-80] vs. 71 [IQR 68-76] years), and had a higher incidence of complications such as pulmonary failure, pneumonia, and acute renal failure during index hospitalization (all p < 0.05). Patients sent to a SNF were more likely to be readmitted within 30-days (30.1% vs. 13.4%, p < 0.001). The incidence of new complications within 30- and 90-days of discharge was similar regardless of star quality ratings (all p > 0.05). On multivariable analysis, Charlson comorbidity score ≥3 was the factor most strongly associated with 30-day readmission (OR 1.32-15.29, p = 0.016). CONCLUSION: While post-discharge outcomes were similar across SNF quality ratings, roughly one in three Medicare patients discharged to a SNF were readmitted within 30-days.

Use of Machine Learning for Prediction of Patient Risk of Postoperative Complications After Liver, Pancreatic, and Colorectal Surgery.

BACKGROUND: Surgical resection is the only potentially curative treatment for patients with colorectal, liver, and pancreatic cancers. Although these procedures are performed with low mortality, rates of complications remain relatively high following hepatopancreatic and colorectal surgery. METHODS: The American College of Surgeons (ACS) National Surgical Quality Improvement Program was utilized to identify patients undergoing liver, pancreatic and colorectal surgery from 2014 to 2016. Decision tree models were utilized to predict the occurrence of any complication, as well as specific complications. To assess the variability of the performance of the classification trees, bootstrapping was performed on 50% of the sample. RESULTS: Algorithms were derived from a total of 15,657 patients who met inclusion criteria. The algorithm had a good predictive ability for the occurrence of any complication, with a C-statistic of 0.74, outperforming the ASA (C-statistic 0.58) and ACS-Surgical Risk Calculator (C-statistic 0.71). The algorithm was able to predict with high accuracy thirteen out of the seventeen complications analyzed. The best performance was in the prediction of stroke (C-statistic 0.98), followed by wound dehiscence, cardiac arrest, and progressive renal failure (all C-statistic 0.96). The algorithm had a good predictive ability for superficial SSI (C-statistic 0.76), organ space SSI (C-statistic 0.76), sepsis (C-statistic 0.79), and bleeding requiring transfusion (C-statistic 0.79). CONCLUSION: Machine learning was used to develop an algorithm that accurately predicted patient risk of developing complications following liver, pancreatic, or colorectal surgery. The algorithm had very good predictive ability to predict specific complications and demonstrated superiority over other established methods.

Analysis of Authorship in Hepatopancreaticobiliary Surgery: Women Remain Underrepresented.

INTRODUCTION: Given the need to increase female representation in hepatopancreatobiliary (HPB) surgery, as well as the need to increase the academic pipeline of women in this subspecialty, we sought to characterize the prevalence of female authorship in the HPB literature. In particular, the objective of the current study was to determine the proportion of women who published HPB research articles as first, second, or last author over the last decade. METHODS: All articles pertaining to hepatopancreaticobiliary (HPB) surgery appearing in seven surgical journals (Annals of Surgery, British Journal of Surgery, JAMA Surgery, Annals of Surgical Oncology, HPB (Oxford), Surgery, and Journal of Gastrointestinal Surgery) were reviewed for the years 2008 and 2018. Information on sex of author, country of author's institution, and article type was collected and entered into a computerized database. RESULTS: Among the 1473 index articles included in the final analytic cohort, 414 (28%) publications had a woman as the first or last author, while the vast majority (n = 1,059, 72%) had a man as the first or last author. The number of female first authors increased from 15.6% (n = 92/591) in 2008 to 25.7% (n = 227/882) in 2018 (p < 0.001). There were no differences in the proportion of second (n = 123/536, 23.0% vs n = 214/869, 24.6%, p = 0.47) or last (n = 44/564, 7.8% vs n = 88/875, 10.1%, p = 0.15) authors. Women were more likely to publish papers appearing in medium-impact journals (OR 1.40, 95% CI 1.04-1.88) and articles with a female author were more likely to be from a North American institution (referent: North America, Asia OR 0.43, 95% CI 0.31-0.59 vs Europe OR 0.67, 95% CI 0.51-0.87). CONCLUSION: Women first/last authors in HPB research articles have increased over the past 10 years from 22 to 32%. Women as last authors remain low, however, as only 1 in 10 papers had a senior woman author. These data should prompt HPB leaders to find solutions to the gap in female authorship including mentorship of young female researchers and surgeons.

Textbook Outcomes Among Medicare Patients Undergoing Hepatopancreatic Surgery.

OBJECTIVE: To define and test "Textbook Outcome" (TO)-a composite measure for healthcare quality-among Medicare patients undergoing hepatopancreatic resections. Hospital variation in TO and Medicare payments were analyzed. BACKGROUND: Composite measures of quality may be superior to individual measures for the analysis of hospital performance. METHODS: The Medicare Provider Analysis and Review (MEDPAR) Inpatient Files were reviewed to identify Medicare patients who underwent pancreatic and liver procedures between 2013 and 2015. TO was defined as: no postoperative surgical complications, no prolonged length of hospital stay, no readmission ≤ 90 days after discharge, and no postoperative mortality ≤ 90 days after surgery. Medicare payments were compared among patients who achieved TO versus patients who did not. Multivariable logistic regression was used to investigate patient factors associated with TO. A nomogram to predict probability of TO was developed and validated. RESULTS: TO was achieved in 44% (n = 5919) of 13,467 patients undergoing hepatopancreatic surgery. Adjusted TO rates at the hospital level varied from 11.1% to 69.6% for pancreatic procedures and from 16.6% to 78.7% for liver procedures. Prolonged length of hospital stay represented the major obstacle to achieve TO. Average Medicare payments were substantially higher among patients who did not have a TO. Factors associated with TO on multivariable analysis were age, sex, Charlson comorbidity score, previous hospital admissions, procedure type, and surgical approach (all P > 0.05). CONCLUSIONS: Less than one-half of Medicare patients achieved a TO following hepatopancreatic procedures with a wide variation in the rates of TO among hospitals. There was a discrepancy in Medicare payments for patients who achieved a TO versus patients who did not. TO could be useful for the public reporting of patient level hospital performance and hospital variation.

Effect of Surgical Margin Width on Patterns of Recurrence among Patients Undergoing R0 Hepatectomy for T1 Hepatocellular Carcinoma: An International Multi-Institutional Analysis.

INTRODUCTION: Although a positive surgical margin is a known prognostic factor for recurrence, the optimal surgical margin width in the context of an R0 resection for early-stage hepatocellular carcinoma (HCC) is still debated. The aim of the current study was to examine the impact of wide (> 1 cm) versus narrow (< 1 cm) surgical margin status on the incidence and recurrence patterns among patients with T1 HCC undergoing an R0 hepatectomy. METHODS: Between 1998 and 2017, patients with T1 HCC who underwent R0 hepatectomy for stage T1 HCC were identified using an international multi-institutional database. Recurrence-free survival (RFS) was estimated, and recurrence patterns were examined based on whether patients had a wide versus narrow resection margins. RESULTS: Among 404 patients, median patient age was 66 years (IQR: 58-73). Most patients (n = 326, 80.7%) had surgical margin < 1 cm, while 78 (19.3%) patients had a > 1 cm margin. The majority of patients had early recurrences (< 24 months) in both margin width groups (< 1 cm: 70.3% vs > 1 cm: 85.7%, p = 0.141); recurrence site was mostly intrahepatic (< 1 cm: 77% vs > 1 cm: 61.9%, p = 0.169). The 1-, 3-, and 5-year RFS among patients with margin < 1 cm were 77%, 48.9%, and 35.3% versus 81.7%, 65.8%, and 60.7% for patients with margin > 1 cm, respectively (p = 0.02). Among patients undergoing anatomic resection, resection margin did not impact RFS (3-year RFS: < 1 cm: 49.2% vs > 1 cm: 58.9%, p = 0.169), whereas in the non-anatomic resection group, margin width > 1 cm was associated with a better 3-year RFS compared to margin < 1 cm (86.7% vs 47.3%, p = 0.017). On multivariable analysis, margin > 1 cm remained protective against recurrence (HR = 0.50, 95%CI 0.28-0.89), whereas Child-Pugh B (HR = 2.13, 95%CI 1.09-4.15), AFP > 20 ng/mL (HR = 1.71, 95%CI 1.18-2.48), and presence of microscopic lymphovascular invasion (HR = 1.48, 95%CI 1.01-2.18) were associated with a higher hazard of recurrence. CONCLUSION: Resection margins > 1 cm predicted better RFS among patients undergoing R0 hepatectomy for T1 HCC, especially small (< 5 cm) HCC. Although resection margin width did not influence outcomes after anatomic resection, wider margins were more important among patients undergoing non-anatomic liver resections.

Outcomes of Patients with Scirrhous Hepatocellular Carcinoma: Insights from the National Cancer Database.

INTRODUCTION: Scirrhous hepatocellular carcinoma (HCC) is a rare primary liver tumor characterized by extensive fibrosis and production of parathyroid hormone-related peptide. There have been conflicting reports on patient survival in scirrhous versus non-scirrhous HCC. The objective of the present study was to define the clinical features, practice patterns, and long-term outcomes of patients with scirrhous HCC versus non-scirrhous HCC in a propensity score-matched cohort. METHODS: A propensity score-matched cohort was created using data from the National Cancer Database for 2004 to 2015. A multivariable Cox proportional hazards regression analysis was performed to assess the effect of the scirrhous HCC variant on overall survival. RESULTS: Among the 70,426 patients with a diagnosis of HCC who met the inclusion criteria, 99.8% had non-scirrhous HCC (n = 70,290) whereas a small subset had scirrhous HCC (n = 136, 0.19%). While 20,330 (28.9%) patients underwent liver-directed therapy (resection, ablation, and transplantation), the majority did not (n = 50,096, 71.1%). After propensity matching, there were no difference in 1-, 3-, or 5-year overall survival among patients with scirrhous versus non-scirrhous HCC (1-year overall survival (OS), 53.7% versus 51.0%; 3-year OS, 34.6% versus 28.7%; and 5-year OS, 18.0% versus 21.0%, respectively; p = 0.52). While the scirrhous HCC variant was not associated with survival (hazard ratio [HR] 0.93, 95% CI 0.74-1.16), non-receipt of liver-directed therapy (HR 0.24, 95% CI 0.18-0.32), advanced AJCC stage (III/IV) (HR 2.14, 95% CI 1.55-2.95), and non-academic facilities (HR 0.60, 95% CI 0.49-0.73) remained associated with worse survival. CONCLUSION: Patients with the scirrhous variant had a comparable overall survival compared with individuals who had non-scirrhous HCC. Failure to receive liver-directed therapy, advanced AJCC stage (III/IV), and treatment at a non-academic facility was strongly associated with a worse long-term prognosis.

Impact of Preoperative Cholangitis on Short-term Outcomes Among Patients Undergoing Liver Resection.

BACKGROUND: The impact of preoperative cholangitis (PC) on perioperative outcomes among patients undergoing liver resection remains poorly defined. We sought to characterize the prevalence of PC among patients undergoing hepatectomy and define the impact of PC on postoperative outcomes. METHODS: Patients who underwent liver resection between 2013 and 2015 were identified using the Center for Medicare Services (CMS) 100% Limited Data Set (LDS) Standard Analytic Files (SAFs). Short-term outcomes after liver resection, stratified by the presence of PC, were examined. Subgroup analyses were performed to evaluate the relationship between the timing of liver resection relative to PC. RESULTS: Among 7392 patients undergoing liver resection, 251 patients (3.4%) experienced PC. Patients with PC were more likely to be male (59.0% vs. 50.6%) and to have a benign diagnosis (34.3% vs. 19.8%) compared with patients without PC (both p<0.05). On multivariable analysis, PC was associated with increased odds of experiencing a complication (OR 1.54, 95%CI 1.17-2.03), extended LOS (OR 2.60, 95%CI 1.99-3.39), 90-day mortality (OR 2.31, 95%CI 1.64-3.26), and higher Medicare expenditures (OR 3.32, 95%CI 2.55-4.32). Among patients with PC, requirement of both endoscopic and percutaneous biliary drainage (OR 5.16, 95%CI 1.36-9.61), as well as liver resection < 2 weeks after PC (OR 2.92, 95%CI 1.13-7.57) were associated with higher odds of 90-day mortality. CONCLUSION: Approximately 1 in 30 Medicare beneficiaries undergoing liver resection had a history of PC. PC was associated with an increased risk of adverse short-term outcomes and higher healthcare expenditures among patients undergoing hepatectomy.