ABSTRACT
BACKGROUND AND OBJECTIVES: Early detection of hepatocellular carcinoma (HCC) is associated with improved survival. However, a greater proportion of patients treated at safety net hospitals (SNHs) present with late-stage disease compared to those at academic medical centers (AMCs). This study aims to identify barriers to diagnosis of HCC, highlighting differences between SNHs and AMCs. METHODS: The US Safety Net Collaborative-HCC database was queried. Patients were stratified by facility of diagnosis (SNH or AMC). Patient demographics and HCC screening rates were examined. The primary outcome was stage at diagnosis (AJCC I/II-"early"; AJCC III/IV-"late"). RESULTS: 1290 patients were included; 50.2% diagnosed at SNHs and 49.8% at AMCs. At SNHs, 44.4% of patients were diagnosed late, compared to 27.6% at AMCs. On multivariable regression, Black race was associated with late diagnosis in both facilities (SNH: odds ratio 1.96, p = 0.03; AMC: 2.27, <0.01). Screening was associated with decreased odds of late diagnosis (SNH: 0.46, p = 0.04; AMC: 0.37, p < 0.01). CONCLUSIONS: Black race was associated with late diagnosis of HCC, while screening was associated with early diagnosis across institutional types. These results suggest socially constructed racial bias in screening and diagnosis of HCC. Screening efforts targeting SNH patients and Black patients at all facilities are essential to reduce disparities.
ABSTRACT
BACKGROUND: While hepatocellular carcinoma (HCC) is ideally diagnosed outpatient by screening at-risk patients, many are diagnosed in Emergency Departments (ED) due to undiagnosed liver disease and/or limited access-to-healthcare. This study aims to identify sociodemographic/clinical factors associated with being diagnosed with HCC in the ED to identify patients who may benefit from improved access-to-care. METHODS: HCC patients diagnosed between 2012 and 2014 in the ED or an outpatient setting [Primary Care Physician (PCP) or hepatologist] were identified from the US Safety-Net Collaborative database and underwent retrospective chart-review. Multivariable regression identified predictors for an ED diagnosis. RESULTS: Among 1620 patients, median age was 60, 68% were diagnosed outpatient, and 32% were diagnosed in the ED. ED patients were more likely male, Black/Hispanic, uninsured, and presented with more decompensated liver disease, aggressive features, and advanced clinical stage. On multivariable regression, controlling for age, gender, race/ethnicity, poverty, insurance, and PCP/navigator access, predictors for ED diagnosis were male (odds ratio [OR] 1.6, 95% confidence interval [CI]: 1.1-2.2, p = 0.010), black (OR 1.7, 95% CI: 1.2-2.3, p = 0.002), Hispanic (OR 1.6, 95% CI: 1.1-2.6, p = 0.029), > 25% below poverty line (OR 1.4, 95% CI: 1.1-1.9, p = 0.019), uninsured (OR 3.9, 95% CI: 2.4-6.1, p < 0.001), and lack of PCP (OR 2.3, 95% CI: 1.5-3.6, p < 0.001) or navigator (OR 1.8, 95% CI: 1.3-2.5, p = 0.001). CONCLUSIONS: The sociodemographic/clinical profile of patients diagnosed with HCC in EDs differs significantly from those diagnosed outpatient. ED patients were more likely racial/ethnic minorities, uninsured, and had limited access to healthcare. This study highlights the importance of improved access-to-care in already vulnerable populations.
Subject(s)
Carcinoma, Hepatocellular , Liver Neoplasms , Carcinoma, Hepatocellular/diagnosis , Emergency Service, Hospital , Female , Healthcare Disparities , Humans , Liver Neoplasms/diagnosis , Male , Medically Uninsured , Middle Aged , Retrospective Studies , United States/epidemiologyABSTRACT
BACKGROUND: Although consensus guidelines generally discourage any surgical management (ASM; i.e., resection and/or transplantation) in patients with hepatocellular carcinoma (HCC) and portal vein thrombosis (PVT), recent series from Asia have challenged this paradigm. METHODS: Patients from the US Safety Net Collaborative database (2012-2014) with localized HCC and radiographically confirmed PVT were propensity-score matched based on demographic and clinicopathologic factors associated with receipt of ASM and overall survival (OS). OS was compared between patients undergoing ASM and those not selected for surgery. RESULTS: Of 1910 HCC patients, 207 (14.5%) had localized disease and PVT. The majority received either liver-directed therapies (LDTs; 34%) and/or targeted systemic therapies (36%). Twenty-one patients (10.1%) underwent ASM (resection [n = 11], transplantation [n = 10]); a third experienced any complication with no 30-day mortalities. Independent predictors of undergoing ASM were younger age, recent hepatology consultation, and lower model of end-stage liver disease (MELD) score. After matching for age, comorbidities, MELD, tumor size, receipt of LDT, or systemic therapy, OS was significantly longer for patients selected for ASM versus non-ASM patients (median not reached vs. 5.8 months, p < .001). CONCLUSION: In a large North American multi-institutional cohort, a minority of HCC patients with PVT were selected for ASM. Resection or transplantation was associated with improved survival and may have a role in the multimodality management in selected patients.
Subject(s)
Carcinoma, Hepatocellular/surgery , Hepatectomy/mortality , Liver Neoplasms/surgery , Portal Vein/physiopathology , Venous Thrombosis/physiopathology , Carcinoma, Hepatocellular/pathology , Databases, Factual , Female , Follow-Up Studies , Humans , Liver Neoplasms/pathology , Male , Middle Aged , Prognosis , Propensity Score , Retrospective Studies , Survival Rate , United StatesABSTRACT
BACKGROUND AND OBJECTIVES: Surgical resection is indicated for hepatocellular carcinoma (HCC) patients with Child A cirrhosis. We hypothesize that surgical intervention and survival are limited by advanced HCC presentation at safety net hospitals (SNHs) versus academic medical centers (AMCs). METHODS: Patients with HCC and Child A cirrhosis in the US Safety Net Collaborative (2012-2014) were evaluated. Demographics, clinicopathologic features, operative characteristics, and outcomes were compared between SNHs and AMCs. Liver transplantation was excluded. Kaplan-Meier and Cox proportional-hazards models were used to identify the effect of surgery on overall (OS). RESULTS: A total of 689 Child A patients with HCC were identified. SNH patients frequently presented with T3/T4 stage (35% vs. 24%) and metastases (17% vs. 8%; p < .05). SNH patients were as likely to undergo surgery as AMC patients (17% vs. 18%); however, SNH patients were younger (56 vs. 64 years), underwent minor hepatectomy (65% vs. 38%), and frequently harbored well-differentiated tumors (23% vs. 2%; p < .05). On multivariate analysis, surgical resection and stage, but not hospital type, were associated with improved OS. CONCLUSIONS: Although SNH patients present with advanced HCC, survival outcomes for early stage HCC are similar at SNHs and AMCs. Identifying barriers to early diagnosis at SNH may increase surgical candidacy and improve outcomes.
Subject(s)
Carcinoma, Hepatocellular/mortality , Hepatectomy/mortality , Liver Neoplasms/mortality , Safety-net Providers/statistics & numerical data , Carcinoma, Hepatocellular/pathology , Carcinoma, Hepatocellular/surgery , Female , Follow-Up Studies , Humans , Liver Neoplasms/pathology , Liver Neoplasms/surgery , Male , Middle Aged , Prognosis , Retrospective Studies , Survival RateABSTRACT
BACKGROUND: Access to health insurance and curative interventions [surgery/liver-directed-therapy (LDT)] affects survival for early-stage hepatocellular carcinoma (HCC). The aim of this multi-institutional study of high-volume safety-net hospitals (SNHs) and their tertiary-academic-centers (AC) was to identify the impact of type/lack of insurance on survival disparities across hospitals, particularly SNHs whose mission is to minimize insurance related access-to-care barriers for vulnerable populations. METHODS: Early-stage HCC patients (2012-2014) from the US Safety-Net Collaborative were propensity-score matched by treatment at SNH/AC. Overall survival (OS) was the primary outcome. Multivariable Cox proportional-hazard analysis was performed accounting for sociodemographic/clinical parameters. RESULTS: Among 925 patients, those with no insurance (NI) had decreased curative surgery, compared to those with government insurance (GI) and private insurance [PI, (PI-SNH:60.5% vs. GI-SNH:33.1% vs. NI-SNH:13.6%, p < 0.001)], and decreased median OS (PI-SNH:32.1 vs. GI-SNH:22.8 vs. NI-SNH:9.4 months, p = 0.002). On multivariable regression controlling for sociodemographic/clinical parameters, NI-SNH (HR:2.5, 95% CI:1.3-4.9, p = 0.007) was the only insurance type/hospital system combination with significantly worse OS. CONCLUSION: NI-SNH patients received less curative treatment than other insurance/hospitals types suggesting that treatment barriers, beyond access-to-care, need to be identified and addressed to achieve survival equity in early-stage HCC for vulnerable populations (NI-SNH).
Subject(s)
Carcinoma, Hepatocellular , Liver Neoplasms , Carcinoma, Hepatocellular/therapy , Humans , Liver Neoplasms/therapy , Retrospective Studies , Safety-net Providers , United States , Vulnerable PopulationsABSTRACT
BACKGROUND: Widespread HCV treatment for hepatocellular carcinoma (HCC) patients remains limited. Our aim was to evaluate the association of HCV treatment with survival and assess barriers to treatment. METHODS: Patients in the U.S. Safety Net Collaborative with HCV and HCC were included. Primary outcome was overall survival (OS). Secondary outcomes were recurrence-free survival (RFS) and barriers to receiving HCV treatment. RESULTS: Of 941 patients, 57% received care at tertiary referral centers (n=533), 74% did not receive HCV treatment (n=696), 6% underwent resection (n=54), 17% liver transplant (n=163), 50% liver-directed therapy (n=473), and 7% chemotherapy (n=60). HCV treatment was associated with improved OS compared to no HCV treatment (70 vs 21 months, p<0.01), persisting across clinical stages, HCC treatment modalities, and treatment facilities (all p<0.01). Surgical patients who received HCV treatment had improved RFS compared to those who did not (91 vs 80 months, p=0.03). On MVA, HCV treated patients had improved OS and RFS. On MVA, factors associated with failure to receive HCV treatment included Black race, higher MELD, and advanced clinical stage (all p<0.05). CONCLUSION: HCV treatment for HCC patients portends improved survival, regardless of clinical stage, HCC treatment, or facility type. Efforts must address barriers to HCV treatment.
Subject(s)
Carcinoma, Hepatocellular , Hepatitis C , Liver Neoplasms , Liver Transplantation , Carcinoma, Hepatocellular/therapy , Hepatitis C/diagnosis , Hepatitis C/drug therapy , Humans , Liver Neoplasms/therapy , Retrospective Studies , United States/epidemiologyABSTRACT
BACKGROUND: Safety net hospitals have historically cared for a disproportionate number of patients of low socioeconomic status, racial and ethnic minorities, and patients with cancer. These innate challenges make safety net hospitals important in understanding how to improve access to cancer care in order to fit the needs of vulnerable patients and ultimately improve their outcomes. The purpose of this study is to characterize the current state and treatment of hepatocellular carcinoma (HCC) at Ben Taub Hospital, a safety net hospital in Houston, Texas. MATERIALS AND METHODS: A retrospective chart review was performed to review the demographic characteristics, clinicopathologic data, treatment strategies, and outcomes of HCC patients at Ben Taub Hospital between January 2012 and December 2014. RESULTS: Two-hundred twenty-six men and 78 women with a mean age of 58 y underwent evaluation. Most (87%) were either uninsured or covered by Medicaid. The majority (69%) of patients presented with advanced (stage 2 or more) disease, with 58% of patients presenting with multiple lesions. Of the 40% that presented with a solitary lesion, the average size was 4.97 cm. Transarterial chemoembolization was used in 37% of patients and sorafenib was given to 26% of patients. Five patients underwent successful transplant. One hundred seventeen (38%) patients died of their disease, 25 patients are alive with no evidence of disease, and 159 patients have been lost to follow-up. CONCLUSIONS: Most patients with HCC presented to this safety net hospital with advanced disease; however, multiple local and systemic treatments were offered. Screening programs to detect HCC at an earlier stage are essential for successful long-term outcomes in a resource-strapped hospital with limited access to liver transplantation.
Subject(s)
Carcinoma, Hepatocellular/diagnosis , Health Services Accessibility/statistics & numerical data , Liver Neoplasms/diagnosis , Mass Screening/organization & administration , Safety-net Providers/statistics & numerical data , Carcinoma, Hepatocellular/economics , Carcinoma, Hepatocellular/mortality , Carcinoma, Hepatocellular/therapy , Chemoembolization, Therapeutic/economics , Chemoembolization, Therapeutic/statistics & numerical data , Disease-Free Survival , Female , Follow-Up Studies , Health Services Accessibility/economics , Health Services Needs and Demand/statistics & numerical data , Humans , Liver/pathology , Liver Neoplasms/economics , Liver Neoplasms/mortality , Liver Neoplasms/therapy , Liver Transplantation/economics , Liver Transplantation/statistics & numerical data , Male , Middle Aged , Minority Groups/statistics & numerical data , Neoplasm Staging/economics , Retrospective Studies , Safety-net Providers/organization & administration , Socioeconomic Factors , Sorafenib/economics , Sorafenib/therapeutic useABSTRACT
BACKGROUND: With advances in cross-sectional imaging, pancreatic cysts are more frequently diagnosed and have become a common indication for pancreatectomy. The impact of pancreatectomy in these patients is important. The purpose of this study was to assess short-term outcomes, long-term nutritional status, quality of life (QOL), and pancreas function after pancreatectomy for cystic neoplasms. MATERIALS AND METHODS: At a single institution, patients at least 3 y post-pancreatectomy for benign cystic neoplasms were identified. Using a validated questionnaire, short-term outcomes, long-term outcomes including endocrine and exocrine insufficiency, long-term nutritional status, and preoperative and postoperative QOL were compared based on operation and indication for resection. RESULTS: Among 102 eligible patients, 70 had valid contact information and 51 (72.9%) agreed to participate. Median follow-up was 6 (4-8) y. Patients undergoing pancreatoduodenectomy for benign cysts had higher morbidity than a similar cohort resected for pancreatic adenocarcinoma (patients with at least 1 ≥ grade 2 complication [49.0% versus 31.6%, P = 0.038]). After long-term follow-up, pancreatectomy did not significantly affect perceived QOL. Half of patients had mild-moderate or severe malnourishment, but pancreatic enzyme replacement was reported by only 4 (7.8%) patients. New-onset diabetes was present in 15 (29.4%) patients with median time-to-diagnosis of 6 (1-12) mo after resection. CONCLUSIONS: Pancreatectomy for benign cysts did not negatively impact patients' perceived QOL. However, after long-term follow-up, malnutrition and pancreatic insufficiency occurred in a significant percentage and may be greater than previously estimated. Consideration of short- and long-term outcomes should factor into preoperative counseling, especially in cysts with minimal risk of progression to malignancy.
Subject(s)
Carcinoma, Pancreatic Ductal/surgery , Pancreatic Cyst/surgery , Pancreatic Neoplasms/surgery , Pancreaticoduodenectomy/adverse effects , Postoperative Complications/epidemiology , Aged , Female , Follow-Up Studies , Humans , Male , Middle Aged , Nutritional Status , Patient Reported Outcome Measures , Postoperative Complications/etiology , Prospective Studies , Quality of Life , Treatment OutcomeABSTRACT
BACKGROUND: Identification of incidental pancreatic lesions is increasing because of advancements in imaging. Diagnosis remains a challenge for clinicians, with intrapancreatic accessory spleens (IPAS) posing a unique dilemma. IPAS are frequently resected because of inability to exclude alternate diagnoses, subjecting patients to unnecessary risk. The purpose of this study was to examine our institutional experience with IPAS and develop a multidisciplinary algorithm to improve preoperative diagnosis. MATERIALS AND METHODS: Patients who underwent a distal pancreatectomy at a single institution from 2005 to 2018 were identified from a prospectively maintained database. Examination of final pathology for a diagnosis of IPAS yielded the final cohort. Demographics, preoperative workup, and operative course were reviewed and analyzed. A diagnostic algorithm was composed based on the consensus of a panel of expert pancreatic surgeons, a radiologist, and a pathologist. RESULTS: Ten patients of 303 patients who underwent a distal pancreatectomy were identified with a final pathology of IPAS. The average age was 54 y, 80% were white, and 60% were male. Lesions ranged in size from 7 mm to 5.1 cm in largest diameter (mean 2.2 cm). Lesions were described as round, well-marginated, and enhancing masses within the pancreatic tail. Preoperative workup was variable in terms of imaging and laboratory testing. Diagnostic workups were examined and combined with multidisciplinary input to create a diagnostic algorithm. CONCLUSIONS: Incidental pancreatic lesions like IPAS remain a diagnostic challenge for clinicians. Employing a diagnostic algorithm as proposed may aid in the distinction of malignant and premalignant pathology and prevent unwarranted pancreatic resections.
Subject(s)
Choristoma/diagnosis , Clinical Protocols , Incidental Findings , Pancreatic Diseases/diagnosis , Spleen , Adult , Aged , Choristoma/pathology , Choristoma/surgery , Diagnosis, Differential , Female , Humans , Male , Middle Aged , Pancreatectomy , Pancreatic Diseases/pathology , Pancreatic Diseases/surgery , Pathologists/organization & administration , Patient Care Team/organization & administration , Prospective Studies , Radiologists/organization & administration , Retrospective Studies , Surgeons/organization & administration , Tomography, X-Ray ComputedABSTRACT
BACKGROUND: Early drain removal when postoperative day (POD) one drain fluid amylase (DFA) was ≤5000 U/L reduced complications in a previous randomized controlled trial. We hypothesized that most surgeons continue to remove drains late and this is associated with inferior outcomes. METHODS: We assessed the practice of surgeons in a prospectively maintained pancreas surgery registry to determine the association between timing of drain removal with demographics, comorbidities, and complications. We selected patients with POD1 DFA ≤5000 U/L and excluded those without drains, and subjects without data on POD1 DFA or timing of drain removal. Early drain removal was defined as ≤ POD5. RESULTS: Two hundred and forty four patients met inclusion criteria. Only 90 (37%) had drains removed early. Estimated blood loss was greater in the late removal group (190 mL versus 100 mL, P = 0.005) and pathological findings associated with soft gland texture were more frequent (97 [63%] versus 35 [39%], P < 0.0001). Patients in the late drain removal group had more complications (84 [55%] versus 30 [33%], P = 0.001) including pancreatic fistula (55 [36%] versus 4 [4%], P < 0.0001), delayed gastric emptying (27 [18%] versus 3 [3%], P = 0.002), and longer length of stay (7 d versus 5 d, P < 0.0001). In subset analysis for procedure type, complications and pancreatic fistula remained significant for both pancreatoduodenectomy and distal pancreatectomy. CONCLUSIONS: Despite level one data suggesting improved outcomes with early removal when POD1 DFA is ≤ 5000 U/L, experienced pancreas surgeons more frequently removed drains late. This practice was associated with known risk factors (estimated blood loss, soft pancreas) and may be associated with inferior outcomes suggesting potential for improvement.
Subject(s)
Drainage/methods , Evidence-Based Medicine/methods , Postoperative Care/methods , Postoperative Complications/prevention & control , Practice Patterns, Physicians'/statistics & numerical data , Aged , Amylases/analysis , Female , Humans , Incidence , Male , Middle Aged , Pancreatectomy/adverse effects , Pancreaticoduodenectomy/adverse effects , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Prospective Studies , Registries/statistics & numerical data , Risk Factors , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: Addition of en bloc segmental venous reconstruction (VR) to pancreaticoduodenectomy (PD) for venous involvement of pancreatic tumors increases the complexity of the operation and may increase complications. The long-term mesenteric venous patency rate and oncologic outcome has not been well defined. METHODS: Our prospective database was reviewed to assess 90-day postoperative outcomes for patients who underwent PD or PD + VR (September 2004-June 2016). Two independent observers reviewed CT scans to determine long-term vein patency. In patients with pancreatic ductal adenocarcinoma, the impact of VR on 5-year overall survival was assessed using multivariate Cox proportional hazards regression. Student's t-test was used to evaluate continuous variables and the chi-square test for categorical variables. RESULTS: Three hundred ninety-three patients underwent PD (51 PD + VR). Patients undergoing PD + VR had longer operations (561 ± 119 versus 433 ± 89 min, P < 0.00001) and greater blood loss (768 ± 812 versus 327 ± 423 cc, P < 0.00001). There was no difference in 90-day mortality, overall postoperative complication rates, complication severity grades, reoperation, readmission, or length of stay. 26.7% experienced venous thrombosis. Most thromboses occurred in the first year after surgery, but we also observed late thrombosis in 1 patient after 89-month follow-up. Among 135 patients with pancreatic ductal adenocarcinoma, survival was significantly longer in the PD-alone group (31.3 months [95% confidence interval: 22.9-40.0] versus 17.0 [95% confidence interval: 13.0-19.1], plog-rank = 0.013). CONCLUSIONS: PD + VR does not increase short-term morbidity, but venous thrombosis is frequent and can occur long after surgery. Survival is inferior when VR is required especially in the absence of neoadjuvant chemotherapy.
Subject(s)
Carcinoma, Pancreatic Ductal/surgery , Mesenteric Veins/surgery , Pancreatic Neoplasms/surgery , Pancreaticoduodenectomy/adverse effects , Plastic Surgery Procedures/adverse effects , Postoperative Complications/epidemiology , Venous Thrombosis/epidemiology , Aged , Anastomosis, Surgical/adverse effects , Anastomosis, Surgical/methods , Blood Loss, Surgical/statistics & numerical data , Carcinoma, Pancreatic Ductal/mortality , Female , Follow-Up Studies , Hospital Mortality , Humans , Length of Stay/statistics & numerical data , Male , Middle Aged , Pancreatic Neoplasms/mortality , Pancreaticoduodenectomy/methods , Patient Readmission/statistics & numerical data , Postoperative Complications/etiology , Prospective Studies , Plastic Surgery Procedures/methods , Reoperation/statistics & numerical data , Retrospective Studies , Survival Analysis , Tomography, X-Ray Computed , Treatment Outcome , Vascular Patency , Venous Thrombosis/diagnostic imaging , Venous Thrombosis/etiologyABSTRACT
BACKGROUND: Although used as criterion for early drain removal, postoperative day (POD) 1 drain fluid amylase (DFA) ≤ 5000 U/L has low negative predictive value for clinically relevant postoperative pancreatic fistula (CR-POPF). It was hypothesized that POD3 DFA ≤ 350 could provide further information to guide early drain removal. METHODS: Data from a pancreas surgery consortium database for pancreatoduodenectomy and distal pancreatectomy patients were analyzed retrospectively. Those patients without drains or POD 1 and 3 DFA data were excluded. Patients with POD1 DFA ≤ 5000 were divided into groups based on POD3 DFA: Group A (≤350) and Group B (>350). Operative characteristics and 60-day outcomes were compared using chi-square test. RESULTS: Among 687 patients in the database, all data were available for 380. Fifty-five (14.5%) had a POD1 DFA > 5000. Among 325 with POD1 DFA ≤ 5000, 254 (78.2%) were in Group A and 71 (21.8%) in Group B. Complications (35 (49.3%) vs 87 (34.4%); p = 0.021) and CR-POPF (13 (18.3%) vs 10 (3.9%); p < 0.001) were more frequent in Group B. CONCLUSIONS: In patients with POD1 DFA ≤ 5000, POD3 DFA ≤ 350 may be a practical test to guide safe early drain removal. Further prospective testing may be useful.
Subject(s)
Amylases/metabolism , Clinical Enzyme Tests , Device Removal/methods , Drainage/instrumentation , Pancreatectomy , Pancreaticoduodenectomy , Time-to-Treatment , Adult , Aged , Biomarkers/metabolism , Databases, Factual , Device Removal/adverse effects , Drainage/adverse effects , Female , Humans , Male , Middle Aged , Pancreatectomy/adverse effects , Pancreatic Fistula/etiology , Pancreatic Fistula/prevention & control , Pancreaticoduodenectomy/adverse effects , Predictive Value of Tests , Retrospective Studies , Risk Factors , Time Factors , Treatment OutcomeABSTRACT
OBJECTIVE: The objective of this study was to test the hypothesis that distal pancreatectomy (DP) without intraperitoneal drainage does not affect the frequency of grade 2 or higher grade complications. BACKGROUND: The use of routine intraperitoneal drains during DP is controversial. Prior to this study, no prospective trial focusing on DP without intraperitoneal drainage has been reported. METHODS: Patients undergoing DP for all causes at 14 high-volume pancreas centers were preoperatively randomized to placement of a drain or no drain. Complications and their severity were tracked for 60 days and mortality for 90 days. The study was powered to detect a 15% positive or negative difference in the rate of grade 2 or higher grade complications. All data were collected prospectively and source documents were reviewed at the coordinating center to confirm completeness and accuracy. RESULTS: A total of 344 patients underwent DP with (N = 174) and without (N = 170) the use of intraperitoneal drainage. There were no differences between cohorts in demographics, comorbidities, pathology, pancreatic duct size, pancreas texture, or operative technique. There was no difference in the rate of grade 2 or higher grade complications (44% vs. 42%, P = 0.80). There was no difference in clinically relevant postoperative pancreatic fistula (18% vs 12%, P = 0.11) or mortality (0% vs 1%, P = 0.24). DP without routine intraperitoneal drainage was associated with a higher incidence of intra-abdominal fluid collection (9% vs 22%, P = 0.0004). There was no difference in the frequency of postoperative imaging, percutaneous drain placement, reoperation, readmission, or quality of life scores. CONCLUSIONS: This prospective randomized multicenter trial provides evidence that clinical outcomes are comparable in DP with or without intraperitoneal drainage.
Subject(s)
Drainage , Pancreatectomy/methods , Postoperative Complications/prevention & control , Aged , Drainage/methods , Female , Follow-Up Studies , Humans , Male , Middle Aged , Outcome Assessment, Health Care , Postoperative Complications/diagnosis , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Prospective StudiesABSTRACT
BACKGROUND: Disparities in colon cancer survival have been reported to result from advanced stage at diagnosis and delayed therapy. We hypothesized that delays in treatment among medically underserved patients occur as a result of system-level barriers in a safety-net hospital system. MATERIALS AND METHODS: Retrospective review and analysis of colon cancer patients treated in a large safety-net hospital system between May 2008 and May 2012. Data were collected on demographics, stage at diagnosis, time to surgery, time to adjuvant chemotherapy, and vital status. Regression analyses were performed to determine predictors of delays and failure to receive therapy. RESULTS: Of 248 patients treated for colon cancer, 56% (n = 140) had advanced disease at the time of presentation; furthermore, 29.1% of all colectomies for colon cancer were performed on an urgent or emergent basis. Thirty-six patients with stage III and IV disease did not receive chemotherapy (26%). Race, age, gender, and hospice care did not predict receipt of chemotherapy or delays to treatment. Patients with stage I colon cancer had a significantly longer interval between diagnosis and elective surgery when compared with patients with stage II, III, and IV colon cancer, with only 10% (n = 3) undergoing resection sooner than 6 wk after diagnosis. CONCLUSIONS: One in three patients diagnosed with colon cancer in a large safety-net hospital system require urgent or emergent surgery, and one in two present with advanced disease. Reducing disparities should focus on earlier diagnosis of colon cancer and improving access to surgical specialists.
Subject(s)
Adenocarcinoma/therapy , Colonic Neoplasms/therapy , Safety-net Providers/statistics & numerical data , Aged , Female , Humans , Male , Middle Aged , Retrospective Studies , Time FactorsABSTRACT
OBJECTIVE: To test by randomized prospective multicenter trial the hypothesis that pancreaticoduodenectomy (PD) without the use of intraperitoneal drainage does not increase the frequency or severity of complications. BACKGROUND: Some surgeons have abandoned the use of drains placed during pancreas resection. METHODS: We randomized 137 patients to PD with (n = 68, drain group) and without (n = 69, no-drain group) the use of intraperitoneal drainage and compared the safety of this approach and spectrum of complications between the 2 groups. RESULTS: There were no differences between drain and no-drain cohorts in demographics, comorbidities, pathology, pancreatic duct size, pancreas texture, baseline quality of life, or operative technique. PD without intraperitoneal drainage was associated with an increase in the number of complications per patient [1 (0-2) vs 2 (1-4), P = 0.029]; an increase in the number of patients who had at least 1 ≥grade 2 complication [35 (52%) vs 47 (68%), P = 0.047]; and a higher average complication severity [2 (0-2) vs 2 (1-3), P = 0.027]. PD without intraperitoneal drainage was associated with a higher incidence of gastroparesis, intra-abdominal fluid collection, intra-abdominal abscess (10% vs 25%, P = 0.027), severe (≥grade 2) diarrhea, need for a postoperative percutaneous drain, and a prolonged length of stay. The Data Safety Monitoring Board stopped the study early because of an increase in mortality from 3% to 12% in the patients undergoing PD without intraperitoneal drainage. CONCLUSIONS: This study provides level 1 data, suggesting that elimination of intraperitoneal drainage in all cases of PD increases the frequency and severity of complications.
Subject(s)
Drainage/methods , Pancreaticoduodenectomy , Postoperative Care/methods , Postoperative Complications/prevention & control , Adult , Aged , Early Termination of Clinical Trials , Female , Follow-Up Studies , Humans , Incidence , Length of Stay , Male , Middle Aged , Pancreatic Fistula/epidemiology , Pancreatic Fistula/etiology , Pancreatic Fistula/prevention & control , Pancreaticoduodenectomy/mortality , Postoperative Care/adverse effects , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Prospective Studies , Severity of Illness Index , Treatment OutcomeABSTRACT
BACKGROUND: Although mortality following pancreaticoduodenectomy is decreasing, postoperative morbidity remains high. It was hypothesized that culture-directed treatment of bacteriobilia would decrease the incidence of infectious complications following pancreaticoduodenectomy. METHODS: In a retrospective study of 197 pancreaticoduodenectomy patients, those in the control group (n = 128, 2005-2009) were given perioperative prophylactic antibiotics, whereas those in the treatment group (n = 69, 2009-2011) were continued on antibiotics until intraoperative bile culture results became available. Patients with bacteriobilia received 10 days of antibiotic treatment, which was otherwise discontinued in patients without bacteriobilia. Various complication rates were compared using Fisher's exact test for categorical variables, Wilcoxon rank sum test for ordinal variables, and a two-sample t-test for continuous variables. RESULTS: Demographics, comorbidities, baseline clinical characteristics, and intraoperative and postoperative variables were similar between the two groups. There were higher incidences of elevated creatinine (19% versus 4%; P = 0.004) and preoperative hyperglycaemia (18% versus 7%; P = 0.053) in the control group. Fewer patients in the control group underwent preoperative biliary stenting (48% versus 67%; P = 0.017) and intraperitoneal drains were placed at the time of resection more frequently in the control group (85% versus 38%; P < 0.001). Bacteriobilia was found in 59% of patients. Treatment of bacteriobilia was associated with a decrease in the rate of postoperative wound infections (12% in the control group versus 3% in the treatment group; P = 0.036) and overall complication severity score (1 in the control group versus 0 in the treatment group; P = 0.027). CONCLUSIONS: Prolonged antibiotic therapy for bacteriobilia may decrease postoperative wound infection rates after pancreaticoduodenectomy. A randomized prospective trial is warranted to provide evidence to further support this practice.
Subject(s)
Anti-Bacterial Agents/administration & dosage , Bile Duct Diseases/drug therapy , Bile/microbiology , Pancreaticoduodenectomy/adverse effects , Surgical Wound Infection/prevention & control , Aged , Antibiotic Prophylaxis , Bile Duct Diseases/diagnosis , Bile Duct Diseases/microbiology , Drug Administration Schedule , Female , Humans , Male , Middle Aged , Retrospective Studies , Surgical Wound Infection/microbiology , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: Undocumented immigrants have been shown to be predisposed to worse clinical outcomes than the general population. This study examines survival in socioeconomically disadvantaged Hispanic documented and undocumented breast cancer patients. METHODS: Analysis of a prospective breast cancer database of patients treated in a safety-net hospital system. Overall survival was the primary outcome, and advanced stage at diagnosis (regional and metastatic) was a secondary outcome. Survival analysis and multivariate regression modeling were performed. RESULTS: Seven hundred fifty-one breast cancer patients were identified. Undocumented patients presented at an earlier age and were likely to present with advanced stage. After adjusting for covariates, undocumented status was not associated with increased mortality. The diagnosis-to-treatment interval was significantly longer in undocumented patients. CONCLUSIONS: Despite undocumented patients presenting at a younger age, they have similar mortality compared with documented patients. This finding is partly explained by the local treatment afforded by undocumented patients, further studies are necessary to detail the reasons for these differences in presentation and outcome.
Subject(s)
Breast Neoplasms/ethnology , Breast Neoplasms/mortality , Emigrants and Immigrants , Healthcare Disparities , Hispanic or Latino , Vulnerable Populations , Adult , Breast Neoplasms/pathology , Documentation , Female , Humans , Middle Aged , Neoplasm Staging , Proportional Hazards ModelsABSTRACT
BACKGROUND: Granulomatous mastitis (GM) is a rare, chronic, inflammatory condition of the breast with unknown etiology that affects women of child-bearing age. It can be mistaken radiographically and clinically for breast cancer and due to its rarity can cause a delay in establishing a definitive diagnosis and subsequent initiation of treatment. Furthermore, GM has a progressive clinical course with multiple recurrences. To date, there is no universally accepted treatment for GM. The goal of this study is to review the experience with granulomatous mastitis at a large inner-city public hospital over a 10-y period. METHODS: A retrospective review of a prospectively maintained institutional database was queried for all patients with a histopathologic diagnosis of GM between July 1, 2000 and July 1, 2010. A separate database was created for these patients, and data was collected from electronic medical records and paper charts. Demographic, clinical, and outcomes data were analyzed using summary statistics. RESULTS: A total of 41 cases were identified. The median age at time of diagnosis was 34 y. Thirty-three (80%) patients were of Hispanic ethnicity. The most common physical findings were mass (n = 32, 78%), tenderness (n = 17, 41%), and erythema (n = 12, 29%). Three (7%) patients had a previous history of treatment for tuberculosis whereas 12 (29%) patients were human immunodeficiency virus-positive. Mammography and ultrasonography noted mass (n = 14, 34% and n = 15, 37%, respectively) as the most common radiographic finding. Core needle biopsy and incisional biopsy were used with equal frequency (n = 16, 37%) to establish a definitive pathologic diagnosis. The median number of days between onset of symptoms and definitive diagnosis was 73. Thirteen (32%) patients received antibiotics as initial treatment, whereas 23 (56%) underwent surgical procedures and 1 (2%) received steroid therapy. Steroids were used at any point in the clinical course of 7 (17%) patients, and none of these patients required definitive surgical treatment. CONCLUSIONS: GM affects women of childbearing age and typically presents as an inflamed breast mass with or without pain. The clinical features of GM among Hispanic patients are similar to those among other study populations in the reported literature. This disease is a diagnostic and therapeutic challenge and a high degree of clinical suspicion is warranted. Treatment with steroids may obviate the need for surgery in some patients. Reported recurrence rates for GM are high, and long-term follow-up is essential.
Subject(s)
Breast Neoplasms/diagnosis , Granulomatous Mastitis/diagnosis , Hospitals, County , Hospitals, Urban , Adult , Anti-Bacterial Agents/therapeutic use , Biopsy , Breast/surgery , Databases, Factual , Diagnosis, Differential , Disease Progression , Female , Granulomatous Mastitis/drug therapy , Granulomatous Mastitis/surgery , Humans , Mammography , Recurrence , Retrospective Studies , Steroids/therapeutic use , UltrasonographyABSTRACT
BACKGROUND: Pancreatobiliary (PB) disorders, especially cancer, negatively affect patients' health-related quality of life (HRQoL). However, the influence of baseline, preintervention HRQoL on perioperative and oncologic outcomes has not been well defined. We hypothesized that low baseline HRQoL is associated with worse perioperative and long-term survival outcomes for PB surgical patients. STUDY DESIGN: Pretreatment Functional Assessment of Cancer Therapy - Hepatobiliary Survey results and clinical data from PB patients (2008 to 2016) from a single center's prospective database were analyzed. Survey responses were aggregated into composite scores and divided into quintiles. Patients in the highest quintile of HRQoL were compared to patients in the bottom four quintiles combined. Overall survival (OS) and disease-free survival (DFS) were analyzed using the Kaplan-Meier method. Logistic and Cox regressions were used to determine associations between quintiles of HRQoL scores and 30-day complications and long-term survival, respectively. RESULTS: Of 162 patients evaluated, 99 had malignancy, and 63 had benign disease. Median follow-up was 31 months. Baseline HRQoL scores were similar for benign and malignant disease (p = 0.42) and were not associated with the development of any (p = 0.08) or major complications (p = 0.64). Patients with highest quintile HRQoL scores had improved 3-year OS (84.6 vs 61.7%, p = 0.03) compared to patients in the lowest four quintiles of HRQoL. Among cancer patients only, those with the highest quintile scores had improved 3-year OS (81.6 vs 47.4%, p = 0.02). On multivariable analysis, highest quintile HRQoL scores were associated with longer OS and DFS for patients with malignancy. CONCLUSIONS: Pretreatment HRQoL was associated with both OS and DFS among PB patients and might have prognostic utility. Future studies are necessary to determine whether patients with poorer HRQoL may benefit from targeted psychosocial interventions.
Subject(s)
Quality of Life , Humans , Quality of Life/psychology , Prognosis , Disease-Free Survival , Progression-Free Survival , Surveys and QuestionnairesABSTRACT
BACKGROUND: Malignant small bowel obstruction has a poor prognosis and is associated with multiple related symptoms. The optimal treatment approach is often unclear. We aimed to compare surgical versus non-surgical management with the aim to determine the optimal approach for managing malignant bowel obstruction. METHODS: S1316 was a pragmatic comparative effectiveness trial done within the National Cancer Trials Network at 30 hospital and cancer research centres in the USA, Mexico, Peru, and Colombia. Participants had an intra-abdominal or retroperitoneal primary cancer confirmed via pathological report and malignant bowel disease; were aged 18 years or older with a Zubrod performance status 0-2 within 1 week before admission; had a surgical indication; and treatment equipoise. Participants were randomly assigned (1:1) to surgical or non-surgical treatment using a dynamic balancing algorithm, balancing on primary tumour type. Patients who declined consent for random assignment were offered a prospective observational patient choice pathway. The primary outcome was the number of days alive and out of the hospital (good days) at 91 days. Analyses were based on intention-to-treat linear, logistic, and Cox regression models combining data from both pathways and adjusting for potential confounders. Treatment complications were assessed in all analysed patients in the study. This completed study is registered with ClinicalTrials.gov, NCT02270450. FINDINGS: From May 11, 2015, to April 27, 2020, 221 patients were enrolled (143 [65%] were female and 78 [35%] were male). There were 199 evaluable participants: 49 in the randomised pathway (24 surgery and 25 non-surgery) and 150 in the patient choice pathway (58 surgery and 92 non-surgery). No difference was seen between surgery and non-surgery for the primary outcome of good days: mean 42·6 days (SD 32·2) in the randomised surgery group, 43·9 days (29·5) in the randomised non-surgery group, 54·8 days (27·0) in the patient choice surgery group, and 52·7 days (30·7) in the patient choice non-surgery group (adjusted mean difference 2·9 additional good days in surgical versus non-surgical treatment [95% CI -5·5 to 11·3]; p=0·50). During their initial hospital stay, six participants died, five due to cancer progression (four patients from the randomised pathway, two in each treatment group, and one from the patient choice pathway, in the surgery group) and one due to malignant bowel obstruction treatment complications (patient choice pathway, non-surgery). The most common grade 3-4 malignant bowel obstruction treatment complication was anaemia (three [6%] patients in the randomised pathway, all in the surgical group, and five [3%] patients in the patient choice pathway, four in the surgical group and one in the non-surgical group). INTERPRETATION: In our study, whether patients received a surgical or non-surgical treatment approach did not influence good days during the first 91 days after registration. These findings should inform treatment decisions for patients hospitalised with malignant bowel obstruction. FUNDING: Agency for Healthcare Research and Quality and the National Cancer Institute. TRANSLATION: For the Spanish translation of the abstract see Supplementary Materials section.