Treatment of locally advanced pancreatic cancer using localized trans-arterial micro perfusion of gemcitabine: combined analysis of RR1 and RR2.

BACKGROUND: Locally advanced pancreatic cancer (LAPC) comprises 40% of pancreatic cancer diagnoses and has a relatively poor prognosis. Trans-arterial micro perfusion (TAMP)-mediated chemotherapy delivery to the primary tumor is a novel approach worthy of investigation. The RR1 (dose escalation) and RR2 (observational) studies examined the safety and preliminary efficacy of TAMP-delivered gemcitabine for LAPC. PATIENTS AND METHODS: RR1 and RR2 data were pooled. Both studies enrolled patients with LAPC with histologically confirmed adenocarcinoma. Participant data, including age, sex, race, stage, previous treatments, toxicity, disease progression, and death, were collected. Median number of cycles and average treatment dosage were calculated. Overall survival (OS) was determined for the whole group and separately for patients who received and did not receive previous treatments. Aims of the analysis were to assess procedure safety, OS, and evaluate factors associated with OS. RESULTS: The median age of the 43 patients enrolled in RR1 and RR2 was 72 years (range, 51-88 years). Median OS for the 35 eligible patients with stage III disease was 12.6 months (95% CI, 2.1-54.2 months). Previous chemoradiation was associated with significantly longer OS [27.1 months (95% CI, 8.4-40.6 months)] compared to previous systemic chemotherapy [14.6 months (95% CI, 6.4-54.2 months)] or no prior treatment [7.0 months (95% CI, 2.1-35.4 months)] (P < .001). The most common adverse events were GI related (abdominal pain, emesis, and vomiting); the most common grade 3 toxicity was sepsis. CONCLUSION: Study results indicate that TAMP-mediated gemcitabine delivery in patients with LAPC is potentially safe, feasible, and provides potential clinical benefits. CLINICAL TRIAL REGISTRATION: NCT02237157 (RR1) and NCT02591082 (RR2).

A simple matrix to predict treatment success and long-term survival among patients undergoing pancreatectomy.

BACKGROUND: A more accurate measure of long-term survival among patients who have undergone a successful resection for pancreatic adenocarcinoma may be computed by accounting for time already survived during the initial treatment window. METHODS: Patients diagnosed with pancreatic adenocarcinoma, from 2004 through 2013, were identified from the American College of Surgeons National Cancer Database (NCDB). A risk-stratification matrix was constructed including age, histopathologic factors and the use of adjuvant therapy, given successful treatment and survival at 3-month following diagnosis. RESULTS: A total of 25,897 patients (50% male, 53% >65 years of age) presented with stage I-III pancreatic cancer. The majority of patients had tumors >2 cm size (82%), grade I/II (65%), lymphatic invasion (LI) (66%), and negative margins (76%). A survival advantage for adjuvant therapy was observed among all patients, independent of their risk-profile. For example, a patient ≤65 years of age, with early stage cancer (size ≤2 cm, grade I/II, -ve LI, -ve margins) who received adjuvant therapy had a 62% probability of being alive beyond three years (95%CI = 59%-66%). In contrast, the survival probability decreased to 53% (95%CI = 59%-66%) without adjuvant therapy. CONCLUSIONS: These results provide surgeons and patients with more accurate information regarding long-term survival, as well as the benefit of opting for adjuvant therapy after successful pancreatic surgery.

Emerging Role of Immune Checkpoint Blockade in Pancreatic Cancer.

Immune checkpoint blockade (ICB) with programmed cell death protein-1(PD-1)/programmed death ligand -1(PD-L1) antibodies has revolutionized the management of several cancers, especially non-small cell lung cancer, melanoma, urothelial, and renal cancer. Pancreatic ductal adenocarcinoma (PDAC) is one of the most aggressive cancers associated with high morbidity and mortality. Based on available data, it's obvious that ICB has limited success in PDACs, which can be explained by the low immunogenicity and immunosuppressive tumor microenvironment of these tumors. In this review article, we focus on PD-L1 expression and microsatellite instability (MSI) in PDAC, and their roles as prognostic and predictive markers. We also discuss data supporting combination therapies to augment cancer immunity cycle. Combining anti-PD-1/PD-L1 agents with other modalities such as vaccines, chemotherapy, and radiation could potentially overcome resistance patterns and increase immune responsiveness in PDAC.

Impact of malnutrition on gastrointestinal surgical patients.

BACKGROUND: The accurate diagnosis of malnutrition is imperative if we are to impact outcomes in the malnourished. The American Society of Parenteral and Enteral Nutrition (ASPEN) and Academy of Nutrition and Dietetics (AND), in an attempt to address this issue, have provided evidence-based criteria to diagnose malnutrition. The purpose of this study was to validate the ASPEN/AND criteria in a cohort of patients from a single high-volume surgical oncology unit. METHODS: Patients undergoing major abdominal surgery from June 2013 to March 2015 were classified by their nutritional status using the ASPEN/AND criteria. RESULTS: A total of 490 patients were included. Median age was 64 y, a majority were female (50.6%), white (60.2%), underwent elective procedures (77.6%), had a Charlson comorbidity score (CCS) of 3-5 (40.0%), and a Clavien-Dindo complication (CDC) grade of 0-II (81.2%). A total of 93 (19.0%) patients were classified as moderately/severely malnourished. On univariate analysis, malnourished patients were more likely to be older, undergo emergent procedures, and have a CCS >5 (P < 0.05). Malnutrition was also associated with a longer postoperative length of stay (LOS), higher cost, higher in-hospital mortality, more severe complications, and higher readmission rates (P < 0.05). Multivariate analysis reaffirmed the association between malnutrition, LOS (odds ratio [OR] = 1.67), and cost (OR = 2.49), P < 0.05. Complications (OR = 1.35), mortality rates (OR = 3.05), and readmission rates (OR = 1.34) P > 0.05 failed to reach significance. CONCLUSIONS: Malnutrition worsens LOS and cost. Utilization of standardized criteria consistently identifies patients at risk of negative outcomes who may benefit from perioperative nutritional support.

Patterns of node mapping differ for axial and extremity primary cutaneous melanoma: A case for a more selective use of pre-operative imaging.

PURPOSE: Preoperative lymphoscintigraphy for sentinel lymph node mapping in melanoma improves the ability to locate nodes. However, it still remains unclear whether this step is required for all patients. METHODS: Patients diagnosed with cutaneous melanoma from 1996 to 2012 were identified. Exclusion criteria were in situ disease, metastatic disease, or no SLN biopsy. RESULTS: 214 patients were evaluated. Median age was 57 years, the majority were male (59.8%), white (97.2%), and stage I (60.7%). SLN revealed metastatic disease in 14.5% of patients. The most common primary site was the trunk (43.4%) followed by head and neck (21%), upper extremity (19.2%), and lower extremity (16.4%). Multiple lymphatic basins were most common for head and neck lesions (66.7%) followed by those on the trunk (28.8%), with fewer identified when lower (11.4%), and upper extremities were involved (4.2%). When comparison was restricted to extremity vs. axial, a single basin was noted in 94.5% vs. 59.9% of patients, p < 0.0001. For all extremity lesions the SLN was located in the primary basin. Additional sites included in-transit (popliteal) and second tier basins. The only melanomas with bilateral or contralateral SLN were axial melanomas. CONCLUSIONS: Patients with axial melanomas benefit most from lymphoscintigraphy. This step may not be required for extremity melanoma.

Radiotherapy associated with improved survival for high-grade sarcoma of the extremity.

BACKGROUND: The impact of radiotherapy on local control in limb-preserving surgery for high-risk sarcoma has been well studied. However, the impact of the use and timing of radiation therapy on survival is unclear. METHODS: From 1988 to 2010, patients with Stage III extremity sarcoma were identified within the SEER registry and cohorts were created using propensity score matching between irradiated and non-irradiated groups. RESULTS: A total of 2,606 patients were identified, with a median age of 59 years a majority were white (81%), male (54%), received radiotherapy (78%), and had lower extremity (80%) sarcomas. The most common subtype was fibrohistiocytic (29.8%). Patients treated with radiotherapy were younger (57.2 vs. 60.3 years) and differed in subtype compared to those untreated. The matched cohorts were better balanced for all factors. Radiation therapy was associated with a 5% 5-year survival advantage on univariate analysis for both the unmatched (P = 0.002) and matched cohorts (P = 0.01). On multivariate analysis radiotherapy was associated with a 20% and 30% survival advantage for the matched and unmatched cohorts, respectively (P ≤ 0.02). The timing of radiotherapy did not affect survival. CONCLUSIONS: Radiotherapy, regardless of the timing, is associated with improved survival in high-risk sarcoma.

Assessment of health care cost for complex surgical patients: review of cost, re-imbursement and revenue involved in pancreatic surgery at a high-volume academic medical centre.

BACKGROUND: Pancreatic surgery is complex with the potential for costly hospitalization. METHODS: A retrospective review of patients undergoing a pancreatic resection was performed. RESULTS: The median age of the study population was 64 years. Half of the cohort was female (51%), and the majority were white (62%). Most patients underwent a pancreaticoduodenectomy (PD) (69%). The pre-operative age-adjusted Charlson comorbidity index was zero for 36% (n = 50), 1 for 31% (n = 43) and ≥2 for 33% (n = 45). The Clavien-Dindo grading system for post-operative complication was grade I in 17% (n = 24), whereas 45% (n = 62) were higher grades. The medians direct fixed, direct variable, fixed indirect and total costs were $2476, $15,397, $13,207 and $31,631, respectively. There was a positive contribution margin of $7108, whereas the net margin was a loss of $6790. On univariate analyses, age, type of operation and complication grade were associated with total cost (P ≤ 0.05), whereas operation type and complication grade were associated with a net margin (P = 0.01). These findings remained significant on multivariate analysis (P < 0.05). CONCLUSIONS: Increased cost, reimbursement and revenue were associated with type of operation and post-operative complications.

Sentinel lymph node biopsy is associated with improved survival in Merkel cell carcinoma.

BACKGROUND: Although sentinel lymph node biopsy (SNB) has become a standard for Merkel cell carcinoma (MCC), the impact on survival is unclear. To better define the staging and therapeutic value of SNB, we compared SNB with nodal observation. METHODS: Patients with clinical stage I and II MCC in the Surveillance, Epidemiology, and End Results (SEER) registry undergoing surgery between 2003 and 2009 were identified and divided into two groups-SNB and observation. RESULTS: A total of 1,193 patients met the inclusion criteria (SNB 474 and Observation 719). The median age was 78 years, and the majority were White (95.3 %), male (58.8 %), received radiation therapy (52.9 %) and had T1 tumors (65.3 %). Twenty-four percent had a positive SNB. SNB patients were younger (73 vs. 81 years; p < 0.0001), had T1 tumors (69.6 vs. 62.5 %; p = 0.04) and received radiotherapy (57.8 vs. 40 %; p < 0.0001). Among biopsy patients, a negative SNB was associated with improved 5-year MCC-specific survival (84.5 vs. 64.6 %; p < 0.0001). Univariate analysis demonstrated an increased 5-year MCC-specific survival for the SNB group versus the Observation group (79.2 vs. 73.8 %; p = 0.004), female gender (83.2 vs. 70.4 %; p = 0.0004), and lower T stage (p < 0.0001). On Cox regression, diminished survival was noted for the Observation group (risk ratio [RR] 1.43; p = 0.04), male gender (RR 2.06; p < 0.0001), and a higher T stage. CONCLUSION: SNB for MCC provides prognostic information and is associated with a significant survival advantage.

The influence of sentinel lymph node biopsy on survival for intermediate-thickness melanoma.

BACKGROUND: The Multicenter Selective Lymphadenectomy Trial-1 (MSLT-1) failed to demonstrate a survival advantage for sentinel lymph node biopsy (SNB) in melanoma. This may have been secondary to inadequate statistical power. This study was designed to determine the impact of SNB on melanoma-specific survival (MSS) in a larger patient cohort. METHODS: From 2003-2008, patients with tumors 1-4 mm in thickness and clinically negative nodes were identified within the SEER registry. Propensity score was used to create two matched cohorts: those who underwent a wide excision with SNB or wide excision alone. RESULT: A total of 15,274 met inclusion criteria and 7,910 comprised the match cohort. Average age was 67.4 years. The majority were male (62.3 %) and white (97.2 %). Primary tumors were most frequently nonulcerated (77.1 %), located on the extremity (42.3 %), and T2 (64.1 %). There were 3,955 patients in both the SNB and observation groups. There was no significant difference in gender, ethnicity, ulceration status, primary site, or T-classification between the groups. Improved 5-year MSS was associated with SNB (85.7 vs. 84.0 %), female gender (88.3 vs. 82.7 %), absence of ulceration (87.5 vs. 75.7 %), extremity location (87.4 %), T2 disease (88.6 vs. 77.9 %), and a negative SNB (88.9 vs. 64.8 %). The relationships between observation [hazard ratio (HR) 1.18], male gender (HR 1.33), ulceration (HR 1.77), head-and-neck location (HR 1.34), and T3 disease (HR 1.82) persisted on multivariate analysis. CONCLUSIONS: Status of the sentinel node is the strongest predictor of survival in patients with intermediate thickness melanoma. SNB compared with observation was associated with a modest survival advantage.

Toward eliminating catheter-associated urinary tract infections in an academic health center.

BACKGROUND: Eliminating catheter-associated urinary tract infections (CAUTI) is at the forefront of quality improvement and cost reduction for payers and hospitals alike. Herein we describe a double-focused strategy to eliminate CAUTI's on a surgical oncology unit over the course of 24 mo. METHODS: CAUTI's were tracked on a 30-bed surgical oncology unit 12 mo before and 12 mo after implementation of specific measures aimed at (1) decreasing utilization and (2) increasing catheter bundle and hand hygiene compliance. A policy of early Foley catheter removal was implemented. Univariate analyses were performed comparing nominal and numerical variables between the pre- and post-intervention groups. RESULTS: The pre- and post-intervention groups comprised of 1376 and 1467 patients, respectively. Postintervention, there was a significant decrease in both total Foley (P = 0.02) and patient (P = 0.03) days. This resulted in a significant reduction in utilization rate from 0.28 to 0.24, (P < 0.0001) and median CAUTI rate from 4.6 to 0.0 (P = 0.03). Reduced CAUTIs were associated with significant improvements in monthly bundle compliance at ≥95% (75% versus 17%, P = 0.003) and hand hygiene compliance at ≥95% (92% versus 58%, P = 0.05). Among our thoracic epidural cohort (n = 11), three patients (27%) required reinsertion for urinary retention. None of these epidural patients were diagnosed with a CAUTI. CONCLUSIONS: Although not eliminated entirely, CAUTIs on our unit were significantly reduced through decreased utilization and improved compliance to institutional patient safety measures. Adoption of these strategies to other inpatient units would not only improve patient safety but also result in significant cost savings.

The benefits of liver resection for non-colorectal, non-neuroendocrine liver metastases: a systematic review.

PURPOSE: Defining the benefits of resection of isolated non-colorectal, non-neuroendocrine (NCRNNE) liver metastases is difficult. To better understand the survival benefit in this group of patients, we conducted a systematic review of the previous literature. METHODS: Medline, Web of Knowledge, and manual searches were performed using search terms, such as "liver resection" and "primary tumor." Inclusion criteria were year>1990, >five patients, and median survival reported or derived. An expected median survival was calculated from weighted averages of median survivals, and differences were assessed using a permutation test. RESULTS: A total of 7,857 references were identified. Overall 4,735 abstracts were reviewed; 120 manuscripts evaluated and of these, 73 met the study inclusion criteria. The final population consisted of 3,596 patients with renal (n=234), ovarian (n=119), testicular (n=153), adrenal (n=90), small bowel (n=28), gallbladder (n=21), duodenum (n=38), gastric (n=481), pancreatic (n=55), esophageal (n=23), head and neck (n=15), and lung (n=36) cancers, gastrointestinal stromal tumors (GISTs) (n=106), cholangiocarcinoma (n=13), sarcoma (n=189), and melanoma (n=643). The greatest expected median was 63 months for genitourinary (GU) primaries (n=549; range 5.4-142 months) followed by 44.4 months for breast cancer (n=1,013; range 8-74 months), 22.3 months for gastrointestinal cancer (n=549; range 5-58 months), and 23.7 months for other tumor types (n=1,082; range 10-72 months). Using a permutation test, we observed that survival was best for patients with GU primaries followed by that for breast cancer patients. Additionally, we also observed that survival was similar for those with cancer of the GI tract and other primary sites. CONCLUSIONS: There appears to be a benefit to resection for patients with NCRNNE liver metastases. The degree of survival advantage is predicated by primary site.

Colorectal cancer outcome inequalities: association between population density, race, and socioeconomic status.

INTRODUCTION: Conflicting data exists regarding the influence of population density on colorectal cancer (CRC) outcomes; to better understand this, the present study evaluated outcomes along an urban-rural continuum. METHODS: Colorectal patients aged ≥40 years from 1992 to 2002 were identified in the SEER (Surveillance, Epidemiology, and End Results) Registries of the National Cancer Institute in the USA. RESULTS: A total of 176 011 patients were identified, with median age 71; most lived in populous counties and were white (90%). Patients from large metropolitan counties were more often African-American, and those in rural counties were more likely to be white and have low socioeconomic status (SES). Patients from large metropolitan (>1 million) and rural counties were more likely to have metastatic disease and decreased survival compared to smaller metropolitan counties (<1 million). Late stage of presentation and diminished survival were also associated with African-American race, male sex and lower SES. CONCLUSIONS: Metropolitan counties with populations <1 million had superior CRC outcomes, in part secondary to race and SES.

Neoadjuvant radiotherapy for rectal cancer: adherence to evidence-based guidelines in clinical practice.

BACKGROUND: Implementation of evidence-based standards is problematic. Level 1 evidence, largely predicated on the German Rectal Cancer Study, supports neoadjuvant treatment for patients with stage II/III rectal cancer. The purpose of this study was to determine to what extent this evidence has affected clinical practice. METHODS: Stage II/III rectal cancer patients undergoing surgery from 1998 to 2007 were identified in the SEER tumor registry. Variables were analyzed with SPSS software. Trends were evaluated with regression models. Survivals were compared with the log-rank test. RESULTS: A total of 22,136 patients were identified and 15,021 (67.8%) were treated with adjuvant radiotherapy. A large percentage were >60 years old (64.4%), white (83.0%), male (58.8%), at stage III (55.1%), and treated with neoadjuvant radiotherapy (35.5%). A significant increase in the use of neoadjuvant radiotherapy occurred: from 17% in 1998 to 51% in 2007 (p < 0.001). Scatter-plot best-fit lines for neoadjuvant and adjuvant radiotherapy intersected at approximately year 2002. Significant increases in preoperative radiotherapy were observed for all races and cancer stages (p < 0.001). On unadjusted analysis, race (p = 0.018), sex (p < 0.001), year of diagnosis (p < 0.001), age (p < 0.001), and stage (p < 0.001) were associated with increased likelihood of neoadjuvant radiotherapy. On logistic regression analysis, male sex [odds ratio (OR) 1.14, p < 0.001), year (OR 1.223, p < 0.001), and stage II (OR 1.39, p < 0.001) were predictors of neoadjuvant therapy. CONCLUSIONS: When adjuvant radiotherapy was utilized, there was rapid adoption of a neoadjuvant approach. This trend predated publication of prospective randomized data.

Racial Differences in Patient-Reported Access to Telehealth: An Important and Unmeasured Social Determinant of Health.

PURPOSE: The COVID-19 pandemic expanded opportunities for remote oncology telehealth visits. However, reliable internet connectivity, digital literacy, and patient comfort with virtual medical visits may differ among patients, especially socially disadvantaged groups. The primary aim of this study was to identify barriers that might limit access to telehealth video services. METHODS: First, retrospective analysis was performed of composite administrative data of all patient visits to a large regional cancer center during the pandemic (March 2020 to April 2022). Second, a prospective, cross-sectional study was conducted of patients with known or suspected malignancy over a 6-month period (November 2021 to April 2022). A survey regarding video telehealth accessibility was verbally administered to patients at their clinic visit. RESULTS: Administrative data demonstrated that although Black patients comprised 43% (n = 9,021) of all patient visits (n = 20,953), the proportion of telehealth visits conducted among Black patients was significantly lower compared with White patients (29% v 71%; P < .0001). Of the prospective, cross-sectional study cohort (n = 148), 51.4% of patients (n = 76) were Black, 38.5% (n = 57) resided in a rural county, and 8.1% (n = 12) were Medicaid-insured. Black participants were more likely to self-report lack of internet access (73.7% v 90.4%; P < .01) and were less likely to report having access to or actively using a patient portal (29.0% v 47.2%; P < .001) compared with White patients. The independent association of race and internet access (P < .05) and patient portal use (P = .001) persisted after multivariable analysis. CONCLUSION: Black patients disproportionately underparticipated in telehealth visits, suggesting underlying structural disparities in access to digital care. A greater proportion of Black participants self-reported lack of internet access and access to a patient portal compared with White patients. Ensuring equal internet access and digital literacy will be critical to reduce disparities in cancer care among racial minorities.

Cutaneous apocrine adenocarcinoma: defining epidemiology, outcomes, and optimal therapy for a rare neoplasm.

BACKGROUND AND OBJECTIVES: Apocrine adenocarcinoma is a rare neoplasm. There is a paucity of data on demographics and survival with no clear consensus on management of at risk lymph nodes, therefore, we analyzed a large cohort of patients identified via a national tumor registry. METHODS: Patients ages 17-91 from 1973 to 2006 were identified in the SEER registry and excluded breast and non-cutaneous neoplasms. Data analyzed included basic demographics, survival, surgical therapy, and stage. RESULTS: A total of 186 patients with apocrine adenocarcinoma were identified. The median age was 67 years, 76% were white and there was an equal distribution of males and females. The most common site was trunk (53%) followed by head and neck (35%). Surgery was performed on most patients (96%), either excision (50%) or wide excision (30%). Lymph node metastases were present in 69% patients undergoing node surgery. Median overall survival was 51.5 months. Positive lymph node status (P = 0.006) and metastatic disease (P < 0.001) were associated with diminished overall survival. CONCLUSIONS: Cutaneous apocrine adenocarcinoma is a rare neoplasm. Excision is standard treatment. The most important predictor of survival in localized disease is lymph node status; therefore, sentinel lymph node biopsy could be considered in management of this disease.

Racial Disparity in the Surgical Management of Diverticular Disease.

INTRODUCTION: Although minimally invasive surgery (MIS) has clearly been associated with improved colorectal surgery outcomes, not all populations benefit from this approach. Using a national database, we analyzed both, the trend in the utilization of MIS for diverticulitis and differences in utilization by race. METHODS: Colon-targeted participant user files (PUFs) from 2012 to 18 were linked to respective PUFs in National Surgical Quality Improvement Project. Patients undergoing colectomy for acute diverticulitis or chronic diverticular disease were included. Surgical approach was stratified by race and year. To adjust for confounding and estimate the association of covariates with approach, data were fit using multivariable binary logistic regression main effects model. Using a joint effects model, we evaluated whether the odds of a particular approach over time was differentially affected by race. RESULTS: Of the 46 713 patients meeting inclusion criteria, 83% were white, with 7% black and 10% other. Over the study period, there was a decrease in the rate of open colectomy of about 5% P < .001, and increase in the rate of utilization of laparoscopic and robotic approaches (RC) P < .0001. After adjusting for confounders, black race was associated with open surgery P < .0001. CONCLUSION: There is disparity in the utilization of MIS for diverticulitis. Further research into the reasons for this disparity is critical to ensure known benefits of MIC are realized across all races.

Improvement in Surgical Quality Following Pancreaticoduodenectomy With Increasing Case Volume in a Rural Hospital.

BACKGROUND: The literature is replete with studies that define the nexus of quantity and quality in complex surgical operations. These observations have heralded a call for centralization of care to high-volume centers. The purpose of this study was to chronicle improvements in quality associated with pancreaticoduodenectomy (PD) as a rural hospital matures from a low- to very high-volume center. METHODS: A retrospective review of a prospective pancreatic surgery database was undertaken from July 2007 to June 2020. Annual periods were characterized as low (≤12/year), high (13-29/year), and very high volume (≥30/year). Data for the following quality benchmarks were aggregated and compared: length of stay (LOS), 30-day readmissions, 30-day mortality, and 1- and 3-year survival. A subgroup analysis was undertaken in those patients undergoing PD for adenocarcinoma detailing margin status and number of lymph nodes harvested. Outcomes were compared using the Fisher's exact and Student's t-test. RESULTS: 375 PD were completed over the 13-year period; 62.1% were undertaken for ductal adenocarcinoma. There was a significant decrease in LOS and 30-day readmissions as the institution matured toward very high volume. There were no significant differences in 30-day mortality, 1- and 3-year survival, or margin negativity rates associated with volume. Extent of lymph node harvest significantly improved as institutional experience increased. DISCUSSION: Our pancreatic surgery program matured rapidly from low to very high volume with institutional commitment and dedicated resources. As the institution matured, operational efficiencies and surgical quality improved. Not unexpectedly, biology trumped volume as reflected in 1- and 3-year survival rates.

When Is It Safe to Proceed With Pancreaticoduodenectomy Without Biliary Decompression?

BACKGROUND: An absolute bilirubin level where preoperative biliary decompression (PBD) is indicated before pancreaticoduodenectomy has been elusive. Our goal was to identify a total bilirubin level whereby biliary decompression provides clear benefit, despite associated expenses and potential complications. MATERIALS AND METHODS: We reviewed a prospectively collected database of patients undergoing pancreaticoduodenectomy at the Vidant Medical Center between 2007 and 2016. Patients were arbitrarily subdivided into 3 groups based on presenting bilirubin level (≤10 mg/dL, 10.1-14.9 mg/dL, and ≥15 mg/dL) to determine the presence of overall complications, severe complications (Clavien-Dindo classification ≥3), prolonged length of stay (>1 SD), readmissions, or mortality. RESULTS: Common bile duct stenting independently predicted a higher incidence of complications in patients presenting with bilirubin ≤10 mg/dL (P = .03) vs. those patients going directly to surgery. No differences were observed for patients with bilirubin between 10.1 mg/dL and 14.9 mg/dL. Biliary decompression in patients with bilirubin ≥15 mg/dL independently predicted fewer overall (73.8% vs. 100%, P = .0082) and less severe complications (14.3% vs. 44.5%, P = .03) and lower readmission rates (15.8% vs. 55.6%, P = .03) vs. those going directly to surgery. Patients not undergoing biliary decompression underwent pancreaticoduodenectomy sooner than those decompressed (4.7 days vs. 17.2 days, P = .01). DISCUSSION: All patients presenting with bilirubin ≥15 mg/dL should undergo PBD, while those with bilirubin ≤10 mg/dL should forego stent placement to avoid stent-related complications. The decision to stent between 10.1 and 14.9 mg/dL should be made on a case-by-case basis keeping in mind timeliness to definitive cancer treatment.

Impact of hospital and surgeon volumes in the management of complicated portal hypertension: review of a statewide database in Florida.

Mortality after complex surgical procedures has been shown to be inversely related to hospital volume. The purpose of this study was to determine whether these findings are applicable to radiologic and surgical procedures for complicated portal hypertension. The Agency for Healthcare Administration for the State of Florida database was queried to determine outcomes after transjugular intrahepatic stent shunts (TIPS) or surgical shunts from 2000 to 2003. A total of 1486 patients underwent either TIPS (1321) or surgical shunts (165). Natural breakpoints occurred at two and six procedures per year were correlated with survival for surgical shunts but not TIPS. Overall mortality was not different between TIPS and surgical shunts (11.0 vs. 12.7%, P = 0.51); however, the cost of TIPS was significantly lower (62,000 +/- 58.5 vs. 107,000 +/- 97.8, P < 0.001) as well as the length of hospitalization (9 +/- 9.0 days vs. 15 days +/- 12.6 days, P < 0.001). Surgical procedures for complicated portal hypertension are rapidly being replaced by TIPS. Like with other complex procedures, outcomes are related to hospital volume.