A nationwide analysis of pancreatic cancer trial enrollment reveals disparities and participation problems.

BACKGROUND: Our research group recently surveyed the clinical trial landscape in pancreatic adenocarcinoma and identified 430 active trials. These represent an opportunity to expand treatment options for patients with pancreatic adenocarcinoma. Our primary objective was to detail clinical trial participation among patients with pancreatic adenocarcinoma. Our secondary objective was to evaluate survival. METHODS: We queried the National Cancer Database (2004-2016) for patients with pancreatic adenocarcinoma. Patients were stratified by trial participation: clinical trial or non-trial. Multivariable logistic regression was used to identify variables associated with trial participation. The Kaplan-Meier method and multivariable Cox hazards regression were used to analyze survival. RESULTS: In total, 261,483 patients were included: 1,110 (0.4%) were enrolled in a clinical trial. A total of 57 Black patients participated in a clinical trial (0.19% of Black patients). This was lower compared to White patients (n = 955, 0.49% of White patients, P < .001). After adjusting for demographic and clinical factors, Black patients were less likely to be enrolled in a clinical trial (odds ratio = 0.387, P < .001). Patients treated at nonacademic medical centers were less likely to be in a clinical trial. Trial participation was associated with an increased median survival relative to non-trial patients (stage IV: 9.0 vs 3.8 months, P < .001), and this association remained on multivariable regression (hazard ratio = 0.779, P < .001). CONCLUSION: Fewer than 1% of patients with pancreatic adenocarcinoma participated in a clinical trial. There are racial and sociodemographic disparities in clinical trial enrollment. An association was observed between clinical trial participants and prolonged survival.

Valuing innovative endoscopic techniques: endoscopic suturing to prevent stent migration for benign esophageal disease.

BACKGROUND AND AIMS: Reimbursement often presents a significant barrier to widespread adoption of innovative endoscopic devices. We aimed to determine the value (defined as cost savings to a payer) of endoscopic suturing devices in preventing the migration of esophageal stents placed for benign esophageal diseases. METHODS: A decision-analytic model was constructed from a payer perspective evaluating fully covered metal stent placement for benign esophageal diseases (fistula, leak, perforation, or stricture) in a hospital outpatient setting. The model compared 2 strategies: endoscopic suturing to anchor the stent or no suture. Health care outcomes and costs were derived from published systematic reviews and national databases (U.S. Food and Drug Administration Manufacturer and User Facility Device Experience [MAUDE] for safety data; 2018 Medicare Physician Fee Schedule and Provider Utilization and Payment Data databases for reimbursement data). RESULTS: From a payer perspective, reimbursement for care increased by US$1487.98 without endoscopic suturing per patient, compared with US$621.06 with endoscopic suturing, to cover the risk of stent migration in addition to usual professional and facility reimbursement for stent placement. Thus, an average cost saving of US$866.92 per patient was achieved with endoscopic suturing to reduce stent migration risks. Cost savings associated with suturing ranged from US$147.48 to US$1586.36 per patient, based on the indication for the procedure in sensitivity analysis. Cost savings increased with higher rates of technical success in suture placement. CONCLUSIONS: Creating a defined reimbursement pathway for endoscopic suture fixation of a stent for the treatment of benign esophageal diseases appears to be justified from a payer perspective.

Prevalence and Severity of Fecal Incontinence in Veterans.

BACKGROUND/AIMS: Fecal incontinence (FI) is a common complaint that increases in prevalence with age. Our aim was to determine the prevalence of FI and assess its severity by self-report in a male-predominant Veteran outpatient clinic setting. METHODS: An anonymous 28 item questionnaire was administered to a convenience sample of veterans awaiting appointments. FI was defined as a loss of liquid or solid stool at least monthly. Multivariable logistic and linear models were used to identify predictors of FI prevalence and severity. RESULTS: One hundred thirty-three gastroenterology (GI) participants and 126 primary care (PC) participants completed the survey. Ninety-four of 259 participants (36.3%, 95% confidence interval [CI]: 30.4-42.5) reported an episode of FI (41.4% GI participants vs 31.0% PC participants; P = 0.078) with 33.6% having FI within the last 30 days (36.8% GI participants vs 30.2% PC participants; P = 0.122). Participants with more bowel movements per week (P = 0.005) and per day (P < 0.001) and with a higher Bristol Stool Scale form (P = 0.010) were more likely to have FI. Of participants with FI, mean Fecal Incontinence Severity Index score was 23.0 ± 9.5 with a significantly higher symptom score in GI participants compared to PC participants (25.2 ± 10.0 vs 20.1 ± 8.2; P = 0.011). Few participants had ever been asked by (35.0%) or evaluated by (18.0%) a doctor for FI symptoms. CONCLUSION: FI is a common complaint and under-recognized problem in the male-dominant Veteran population. Despite its prevalence, relatively few participants were asked about FI, with even less being treated. Due to the possible effects and implications on quality of life, more should be done to recognize this condition and arrange treatment.

Lumen apposing metal stents are superior to plastic stents in pancreatic walled-off necrosis: a large international multicenter study.

Background and study aims The use of lumen apposing metal stents (LAMS) during EUS-guided transmural drainage (EUS-TD) of pancreatic walled-off necrosis (WON) has gained popularity. Data supporting their use in WON over plastic stents (PS), however, remain scarce. The aim of this study was to compare the clinical efficacy of LAMS (Axios, Boston Scientific) with PS in WON. Patients and methods This was a multicenter, retrospective study involving 14 centers. Consecutive patients who underwent EUS-TD of WON (2012 - 2016) were included. The primary end point was clinical success defined as WON size ≤ 3 cm within a 6-month period without need for percutaneous drainage (PCD) or surgery. Results A total of 189 patients (mean age 55.2 ±â€Š15.6 years, 34.9 % female) were included (102 LAMS and 87 PS). Technical success rates were similar: 100 % in LAMS and 98.9 % in PS ( P  = 0.28). Clinical success was attained in 80.4 % of LAMS and 57.5 % of PS ( P  = 0.001). Rate of PCD was similar (13.7 % LAMS vs. 16.3 % PS, P  = 0.62), while PS was associated with a greater need for surgery (16.1 % PS vs. 5.6 % LAMS, P  = 0.02). Adverse events (AEs) were observed in 9.8 % of LAMS and 10.3 % of PS ( P  = 0.90) and were rated as severe in 2.0 % and 6.9 %, respectively ( P  = 0.93). After excluding patients with < 6 months follow-up, the rate of WON recurrence following initial clinical success was greater with PS (22.9 % PS vs. 5.6 % LAMS, P  = 0.04). Conclusions When compared to PS, LAMS in WON is associated with higher clinical success, shorter procedure time, lower need for surgery, and lower rate of recurrence.

Acute Biliary Pancreatitis is Associated With Adverse Outcomes in the Elderly: A Propensity Score-Matched Analysis.

GOALS AND BACKGROUND: In the elderly (age, 65 y or older), acute pancreatitis is most frequently because of gallstones; however, there is a paucity of national estimates evaluating outcomes of acute biliary pancreatitis (ABP). Hence, we utilized a representative population database to evaluate the outcomes of ABP among the elderly. STUDY: The National Readmission Database provides longitudinal follow-up of inpatients for 1 calendar-year. All adult inpatients (18 y or older) with an index primary admission for ABP between 2011 and 2014 were evaluated for clinical outcomes of mortality, severe acute pancreatitis (SAP), and 30-day readmission. Outcomes between age groups (≥65 vs. <65 y) were compared using multivariate and one-to-one propensity score-matched analyses. RESULTS: Among 184,763 ABP admissions, 41% were elderly. Index mortality and SAP rates in the elderly were 1.96% and 21.5%, respectively. Elderly patients underwent more ERCPs (27.5% vs. 23.6%; P<0.001) and less frequent cholecystectomies (44.4% vs. 58.7%; P<0.001). Elderly patients had increased odds of mortality and SAP along with an age-dependent increase in the odds of adverse outcomes; patients aged 85 years or older demonstrated the highest odds of SAP [odds ratio (OR), 1.3; 95% confidence interval (CI): 1.2, 1.4] and mortality (OR, 2.2; 95% CI: 1.7, 2.9) within in the elderly cohort. Propensity score-matched analysis substantiated that mortality (OR, 2.8; 95% CI: 2.2, 3.5) and SAP (OR, 1.2; 95% CI: 1.1, 1.3) were increased in the elderly. CONCLUSIONS: Current national survey reveals adverse clinical outcomes among elderly patients hospitalized with ABP. Consequently, there is a need for effective management strategies for this demographic as the aging population is increasing nationally.

Lumen-apposing stents versus plastic stents in the management of pancreatic pseudocysts: a large, comparative, international, multicenter study.

BACKGROUND: Larger caliber lumen-apposing stents (LAMSs) have been increasingly used in the management of pancreatic fluid collections, specifically when solid debris is present; however, their advantages over smaller caliber plastic stents in the management of pancreatic pseudocysts are unclear. The aim of this study was to investigate the safety and efficacy of LAMS specifically in the management of pancreatic pseudocysts compared with double-pigtail plastic stents (DPPSs). METHODS: We performed a multicenter, international, retrospective study between January 2012 and August 2016. A total of 205 patients with a diagnosis of pancreatic pseudocysts were included, 80 patients received LAMSs and 125 received DPPSs. Measured outcomes included clinical success, technical success, adverse events, stent dysfunction, pancreatic pseudocyst recurrence, and need for surgery. RESULTS: Technical success was similar between the LAMS and the DPPS groups (97.5 % vs. 99.2 %; P = 0.32). Clinical success was higher for LAMSs than for DPPSs (96.3 % vs. 87.2 %; P = 0.03). While the need for surgery was similar between the two groups (1.3 % vs. 4.9 %, respectively; P = 0.17), the use of percutaneous drainage was significantly lower in the LAMS group (1.3 % vs. 8.8 %; P = 0.03). At 6-month follow-up, the recurrence rate was similar between the groups (6.7 % vs 18.8 %, respectively; P = 0.12). The rate of adverse events was significantly higher in the DPPS group (7.5 % vs. 17.6 %; P = 0.04). There was no difference in post-procedure mean length of hospital stay (6.3 days [standard deviation 27.9] vs. 3.7 days [5.7]; P = 0.31). CONCLUSION: When compared to DPPSs, LAMSs are a safe, feasible, and effective modality for the treatment of pancreatic pseudocysts and are associated with a higher rate of clinical success, shorter procedure time, less need for percutaneous interventions, and a lower overall rate of adverse events.

Endoscopic intervention and cholecystectomy in pregnant women with acute biliary pancreatitis decrease early readmissions.

BACKGROUND AND AIMS: Acute biliary pancreatitis (ABP) is associated with increased rates of morbidity in pregnancy. Because there is a paucity of population-based studies evaluating ABP in pregnancy, we sought to investigate clinical outcomes in hospitalized pregnant women on a national level. METHODS: By using the Nationwide Readmission Database (2011-2014), we identified all women (age ≥18 years) with an index admission for ABP in the United States. Multivariate and propensity-score matched analyses were performed to evaluate the impact of pregnancy on the clinical outcomes of early readmission and severe acute pancreatitis (SAP) in ABP. RESULTS: There were 7787 hospitalizations for ABP in pregnant women during the study period. The rate of 30-day readmission was 16.26%; 57% of these early readmissions were due to adverse events of ABP. Compared with nonpregnant women with ABP, ERCP (21.1% vs 25.2%; P < .001) and cholecystectomy (52.8% vs 55.2%; P = .02) were performed less frequently during pregnancy. Propensity-score matched analysis revealed an increased risk of 30-day readmissions in pregnancy (odds ratio [OR], 1.96; 95% confidence interval [CI], 1.67-2.30), whereas there was no difference in the risk of SAP (OR, 1.09; 95% CI, 0.76-1.57). Multivariate analysis demonstrated that weekend admission (OR, 1.40; 95% CI, 1.10-1.79) and >1 week of hospitalization (OR, 1.75; 95% CI, 1.24-2.48) increased the risk of 30-day readmission, whereas ERCP (OR, 0.40; 95% CI, 0.27-0.57) and cholecystectomy (OR, 0.13; 95% CI, 0.10-0.18) reduced the odds of early readmission in pregnancy. CONCLUSIONS: Pregnant women with ABP less frequently undergo timely endoscopic biliary decompression and cholecystectomy. These modifiable factors can potentially lower early readmissions in pregnant women.

Endoscopic ultrasound-guided hepaticogastrostomy and antegrade clearance of biliary lithiasis in patients with surgically-altered anatomy.

BACKGROUND AND STUDY AIMS: Endoscopic retrograde cholangiography (ERC) in patients with complex surgically-altered anatomy (SAA) is technically demanding and has limitations. Developments in EUS-guided procedures allow alternative approaches for patients with altered gastrointestinal anatomy and biliary lithiasis. PATIENTS AND METHODS: Single-center, retrospective review of prospectively entered patients with SAA who underwent EUS-guided hepaticogastrostomy (HGS) followed by an interval antegrade endoscopic clearance of biliary lithiasis. RESULTS: 9 patients with Roux-en-Y anatomy underwent HGS to allow clearance of biliary lithiasis after a mean of 2.5 procedures. Technical success was achieved in 100 % of patients utilizing subsequent antegrade endoscopic techniques after HGS including: balloon sweep (9), transpapillary balloon dilation (8), cholangioscopy with electrohydraulic lithotripsy (4), and mechanical lithotripsy (1). HGS stents were removed in all patients. 1 adverse event (cholangitis) occurred after cholangioscopy and prolonged intraductal electrohydraulic lithotripsy. CONCLUSION: EUS-guided antegrade therapy for the management of biliary lithiasis in patients with altered gastrointestinal anatomy appears efficacious with a low risk of adverse events. These preliminary results suggest this approach should be considered at centers with available expertise.

Efficacy and Safety of Digital Single-Operator Cholangioscopy for Difficult Biliary Stones.

BACKGROUND & AIMS: It is not clear whether digital single-operator cholangioscopy (D-SOC) with electrohydraulic and laser lithotripsy is effective in removal of difficult biliary stones. We investigated the safety and efficacy of D-SOC with electrohydraulic and laser lithotripsy in an international, multicenter study of patients with difficult biliary stones. METHODS: We performed a retrospective analysis of 407 patients (60.4% female; mean age, 64.2 years) who underwent D-SOC for difficult biliary stones at 22 tertiary centers in the United States, United Kingdom, or Korea from February 2015 through December 2016; 306 patients underwent electrohydraulic lithotripsy and 101 (24.8%) underwent laser lithotripsy. Univariate and multivariable analyses were performed to identify factors associated with technical failure and the need for more than 1 D-SOC electrohydraulic or laser lithotripsy session to clear the bile duct. RESULTS: The mean procedure time was longer in the electrohydraulic lithotripsy group (73.9 minutes) than in the laser lithotripsy group (49.9 minutes; P < .001). Ducts were completely cleared (technical success) in 97.3% of patients (96.7% of patients with electrohydraulic lithotripsy vs 99% patients with laser lithotripsy; P = .31). Ducts were cleared in a single session in 77.4% of patients (74.5% by electrohydraulic lithotripsy and 86.1% by laser lithotripsy; P = .20). Electrohydraulic or laser lithotripsy failed in 11 patients (2.7%); 8 patients were treated by surgery. Adverse events occurred in 3.7% patients and the stone was incompletely removed from 6.6% of patients. On multivariable analysis, difficult anatomy or cannulation (duodenal diverticula or altered anatomy) correlated with technical failure (odds ratio, 5.18; 95% confidence interval, 1.26-21.2; P = .02). Procedure time increased odds of more than 1 session of D-SOC electrohydraulic or laser lithotripsy (odds ratio, 1.02; 95% confidence interval, 1.01-1.03; P < .001). CONCLUSIONS: In a multicenter, international, retrospective analysis, we found D-SOC with electrohydraulic or laser lithotripsy to be effective and safe in more than 95% of patients with difficult biliary stones. Fewer than 5% of patients require additional treatment with surgery and/or extracorporeal shockwave lithotripsy to clear the duct.

Predictors of Early Hospitalization After Deceased Donor Liver Transplantation.

UNLABELLED: Hospitalizations after solid organ transplantation may affect patient outcomes. Identification of the factors attributed to them may decrease hospitalization rates, reduce overall cost, and improve post-transplant outcomes. We examined the risk factors for early hospitalization within 30 and 90 days after liver transplantation (LT). METHODS: Data on all deceased donor LT recipients (age ≥18 years) transplanted between 2/28/2002-2/27/2007 and discharged alive from the index hospitalization within 30 days of LT were collected (N = 267). Patients were followed up until December 31, 2013. Logistic regression was used to identify the predictors of 30-day hospitalization, and linear regression was used to identify the factors associated with number of days hospitalized during 30- and 90-day hospitalization after LT. Renal risk index (RRI), a recently developed and validated risk score that accurately predicts the post-LT ESRD based upon recipient factors at LT, was computed using RRI calculator ( http://rri.med.umich.edu ). RESULTS: One-third and more than half of the patients had at least one 30- and 90-day hospitalization, respectively. RRI decile (OR 1.12, P = 0.02) and serum sodium at LT (OR 0.90, P < 0.001) were independently associated with 30-day hospitalization after adjusting for MELD score. Serum creatinine at LT (ß = 4.34, P = 0.001) and pre-LT admission days (ß = 0.15, P = 0.027) affected the number of days hospitalized for 90-day hospitalization. RRI was also an independent predictor of post-LT mortality. CONCLUSION: Early hospitalizations within 30 and 90 days after deceased donor LT are common. While all post-LT hospitalization cannot be prevented, efforts should be directed toward risk-based post-discharge care, and coordination of effective transitional care through ambulatory clinics. Implementation of such processes may attenuate early post-LT hospitalization and resource utilization and improve quality.

Predicting the likelihood of a persistent bile duct stone in patients with suspected choledocholithiasis: accuracy of existing guidelines and the impact of laboratory trends.

BACKGROUND: Existing guidelines aim to stratify the likelihood of choledocholithiasis to guide the use of ERCP versus a lower-risk diagnostic study such as EUS, MRCP, or intraoperative cholangiography. OBJECTIVE: To assess the performance of existing guidelines in predicting choledocholithiasis and to determine whether trends in laboratory parameters improve diagnostic accuracy. DESIGN: Retrospective cohort study. SETTING: Tertiary-care hospital. PATIENTS: Hospitalized patients presenting with suspected choledocholithiasis over a 6-year period. INTERVENTIONS: Assessment of the American Society for Gastrointestinal Endoscopy (ASGE) guidelines, its component variables, and laboratory trends in predicting choledocholithiasis. MAIN OUTCOME MEASUREMENTS: The presence of choledocholithiasis confirmed by EUS, MRCP, or ERCP. RESULTS: A total of 179 (35.9%) of the 498 eligible patients met ASGE high-probability criteria for choledocholithiasis on initial presentation. Of those, 99 patients (56.3%) had a stone/sludge on subsequent confirmatory test. Of patients not meeting high-probability criteria on presentation, 111 (34.8%) had a stone/sludge. The overall accuracy of the guidelines in detecting choledocholithiasis was 62.1% (47.4% sensitivity, 73% specificity) based on data available at presentation. The accuracy was unchanged when incorporating the second set of liver chemistries obtained after admission (63.2%), suggesting that laboratory trends do not improve performance. LIMITATIONS: Retrospective study, inconsistent timing of the second set of biochemical markers. CONCLUSION: In our cohort of patients, existing choledocholithiasis guidelines lacked diagnostic accuracy, likely resulting in overuse of ERCP. Incorporation of laboratory trends did not improve performance. Additional research focused on risk stratification is necessary to meet the goal of eliminating unnecessary diagnostic ERCP.

Immunological dysfunction during or after antiviral therapy for recurrent hepatitis C reduces graft survival.

INTRODUCTION: Pegylated interferon and ribavirin (PEGIFN/RBV) therapy for recurrent hepatitis C after liver transplantation (LT) is associated with a lower sustained virological response (SVR) rate as well as more frequent side effects compared to non-transplant patients. We aimed to determine the incidence and clinical characteristics of LT recipients with recurrent hepatitis C who developed immunological dysfunction (ID) during or after PEG-IFN/RBV therapy and to assess its impact on patient and graft survival. METHODS: Seventy-four deceased donor LT recipients with histological recurrence of hepatitis C were treated with PEG-IFN/RBV from 1/00 to 12/08. ID was defined as biopsy-proven rejection or moderate plasma cell hepatitis. Patients were followed up until death, re-LT or 30 September 2011. RESULTS: Twelve patients (16 %) had ID, 8 (10.7 %) had cholestasis without ID, while 54 had no ID/cholestasis during or after discontinuation of PEG-IFN/RBV therapy. Biopsy-proven acute cellular rejection prior to (hazard ratio = 4.87, p = 0.009) and type of immunosuppression at the time of initiation of PEG-IFN/RBV were the only independent predictors of ID. Patients who were on tacrolimus at the time of initiation of PEG-IFN/RBV had a significantly lower risk of ID compared to those who were on cyclosporine (HR 0.254, p = 0.023). Patients with ID had a trend toward a lower SVR rate (25 vs. 54 %, p = 0.18) and a significantly higher rate of graft failure (33 vs. 4 %, p = 0.004) compared to patients with no ID/cholestasis. CONCLUSIONS: ID is common during or after PEG-IFN/RBV therapy for recurrent hepatitis C and frequently associated with decreased graft survival, trending toward low rates of SVR. Careful monitoring of liver biochemistries during or after PEG-IFN/RBV therapy with a low threshold to biopsy patients and particularly those receiving cyclosporine-based immunosuppression may improve outcomes in these patients.