Safety, Efficacy and Clinical Utility of the 5.1mm EndoRotor Powered Debridement Catheter for Treatment of Walled-Off Pancreatic Necrosis.

BACKGROUND AND AIMS: Direct endoscopic necrosectomy (DEN) is a recommended strategy for treatment of walled-off-necrosis (WON). DEN uses a variety of devices including the EndoRotor (Interscope, Inc.) debridement catheter. Recently, a 5.1 mm EndoRotor with increased chamber size and rate of tissue removal was introduced. The aim of this study was to assess the efficacy and safety of this device. METHODS: A multi-center cohort study was conducted at eight institutions including patients who underwent DEN with the 5.1 mm EndoRotor. The primary outcome was the number of DEN sessions needed for WON resolution. Secondary outcomes included the average percent reduction in solid WON debris and decrease in WON area per session, total time spent performing EndoRotor therapy for WON resolution, and adverse events. RESULTS: 64 procedures in 41 patients were included. For patients in which the 5.1 mm EndoRotor catheter was the sole therapeutic modality, an average of 1.6 DEN sessions resulted in WON resolution with an average cumulative time of 85.5 minutes. Of the 21 procedures with data regarding percent of solid debris, the average reduction was 85% +/- 23% per session. Of the 19 procedures with data regarding WON area, the mean area significantly decreased from 97.6 +/- 72.0 cm2 to 27.1 +/- 35.5 cm2 (p<0.001) per session. Adverse events included two intra-procedural LAMS dislodgements managed endoscopically and three perforations none of which were related to EndoRotor. Bleeding was reported in seven cases, none required embolic or surgical therapy and two required blood transfusions. CONCLUSIONS: This is the first multi-center retrospective study to investigate the efficacy and safety of the 5.1 mm EndoRotor catheter for WON. Results from this study showed an average of 1.6 DEN sessions were needed to achieve WON resolution with an 85% single session reduction in solid debris and a 70% single session decrease in WON area with minimal adverse events.

Review of Related Factors for Persistent Risk of Hepatitis B Virus-Associated Hepatocellular Carcinoma.

Chronic hepatitis B virus (HBV) infection is the largest global cause of hepatocellular carcinoma (HCC). Current HBV treatment options include pegylated interferon-alpha and nucleos(t)ide analogues (NAs), which have been shown to be effective in reducing HBV DNA levels to become undetectable. However, the literature has shown that some patients have persistent risk of developing HCC. The mechanism in which this occurs has not been fully elucidated. However, it has been discovered that HBV's covalently closed circular DNA (cccDNA) integrates into the critical HCC driver genes in hepatocytes upon initial infection; additionally, these are not targets of current NA therapies. Some studies suggest that HBV undergoes compartmentalization in peripheral blood mononuclear cells that serve as a sanctuary for replication during antiviral therapy. The aim of this review is to expand on how patients with HBV may develop HCC despite years of HBV viral suppression and carry worse prognosis than treatment-naive HBV patients who develop HCC. Furthermore, HCC recurrence after initial surgical or locoregional treatment in this setting may cause carcinogenic cells to behave more aggressively during treatment. Curative novel therapies which target the life cycle of HBV, modulate host immune response, and inhibit HBV RNA translation are being investigated.

RHEMITT Score Predicts Rebleed After Capsule Endoscopy: First Validation at a U.S. Tertiary Care Center.

BACKGROUND: Patients with obscure gastrointestinal bleeding undergo small bowel capsule endoscopy (SBCE), but often return for recurrent bleeding or anemia. The RHEMITT score evaluates patients based on 7 variables (heart failure, chronic kidney disease, Saurin P1/P2 lesions, major bleeding, incomplete SBCE, smoking status, and endoscopic treatment) and seeks to predict the risk of rebleeding. AIMS: This study aims to perform an external validation of the RHEMITT score in the United States. METHODS: SBCEs performed to evaluate anemia or GI bleeding from a tertiary-care center's PillCam database between 1/22/2018 and 7/21/2020 were reviewed. Variables based on the RHEMITT score were collected. The primary outcome was rebleeding, defined as (1) melena or hematochezia or (2) hemoglobin drop of 2 g/dL. Patient were categorized into low, intermediate, and high-risk categories based on RHEMITT score. The accuracy of the RHEMITT score for predicting rebleeding was assessed. RESULTS: A total of 361 SBCEs were included in the study. Age, indication for SBCE, endoscopic treatment, antiplatelet use, cirrhosis, heart failure, chronic kidney disease, and major bleeding were significantly associated with risk of rebleed (p < 0.05). Each increasing risk category for the RHEMITT score predicted increased probability of this study's primary outcome, rebleeding (p < 0.001). There was a significant association between RHEMITT risk category and rebleeding-free survival (log-rank p < 0.001). An area under the receiver operating characteristic curve for the RHEMITT score was 0.790 (p < 0.001). CONCLUSION: Our findings validate the RHEMITT score and confirm acceptable performance for predicting rebleeding at a tertiary referral center in the United States.

Morphologic Severity of Acute Pancreatitis on Imaging Is Independently Associated with Opioid Dose Requirements in Hospitalized Patients.

BACKGROUND: Prior studies have evaluated clinical characteristics associated with opioid dose requirements in hospitalized patients with acute pancreatitis (AP) but did not incorporate morphologic findings on CT imaging. AIMS: We sought to determine whether morphologic severity on imaging is independently associated with opioid dose requirements in AP. METHODS: Adult inpatients with a diagnosis of AP from 2006 to 2017 were reviewed. The highest modified CT severity index (MCTSI) score and the daily oral morphine equivalent (OME) for each patient over the first 7 days of hospitalization were used to grade the morphologic severity of AP and calculate mean OME per day(s) of treatment (MOME), respectively. Multiple regression analysis was used to evaluate the association of MOME with MCSTI. RESULTS: There were 249 patients with AP, of whom 196 underwent contrast-enhanced CT. The mean age was 46 ± 13.6 years, 57.9% were male, and 60% were black. The mean MOME for the patient cohort was 60 ± 52.8 mg/day. MCTSI (ß = 3.5 [95% CI 0.3, 6.7], p = 0.03), early hemoconcentration (ß = 21 [95% CI 4.6, 39], p = 0.01) and first episode of AP (ß = - 17 [95% CI - 32, - 2.7], p = 0.027) were independently associated with MOME. Among the 19 patients undergoing ≥ 2 CT scans, no significant differences in MOME were seen between those whose MCTSI score increased (n = 12) versus decreased/remained the same (n = 7). CONCLUSION: The morphologic severity of AP positively correlated with opioid dose requirements. No difference in opioid dose requirements were seen between those who did versus those who did not experience changes in their morphologic severity.

Prediction and management of bleeding during endoscopic necrosectomy for pancreatic walled-off necrosis: results of a large retrospective cohort at a tertiary referral center.

BACKGROUND AND AIMS: Lumen-apposing metal stents (LAMSs) provide an endoscopic method for management of walled-off necrosis (WON) and a gateway for the performance of endoscopic necrosectomy (EN). However, bleeding may occur in up to 20% of EN procedures. Predictive factors for bleeding in this patient population are unknown, and there is no agreed-on algorithm for the management of bleeding. The aim of this study was to evaluate preprocedural risk factors for bleeding in patients undergoing endoscopic drainage or EN for WON. METHODS: A retrospective cohort of patients undergoing EN for WON was reviewed. Demographics, comorbidities, concurrent medications, and etiology of pancreatitis were recorded. Pre-, peri-, and postprocedural clinical variables were compared using the χ2 test and independent t test. RESULTS: Between June 2014 and October 2020, 536 ENs were performed in 151 patients. Intraprocedural bleeding occurred during 28 procedures (5.2%) in 18 patients (11.9%). Endoscopic hemostasis was attempted in 8 patients (10 procedures). Eight patients (10 procedures) in total were treated by interventional radiology (IR). Thrombocytopenia (P = .006) and cirrhosis (P = .049) were associated with intraprocedural bleeding, although thrombocytopenia was present in only 1 patient. Identification of a vessel within the cavity endoscopically was also associated with bleeding (P < .001). On multivariate analysis, identification of a vessel within the cavity endoscopically remained a strong predictor of bleeding (P < .001), whereas cirrhosis was no longer significant. Patients who required IR for hemostasis were transfused with significantly more blood before the procedure than patients who did not (3.4 units vs .67 units, P = .002). CONCLUSIONS: EN for WON was associated with a 5.2% per-procedure risk of bleeding and an 11.9% per-patient bleeding risk. Identification of a vessel within the cavity during endoscopy is predictive of bleeding during EN. Patients who require more transfusions before endoscopy may require earlier intervention by IR.

Impact of genetic testing and smoking on the distribution of risk factors in patients with recurrent acute and chronic pancreatitis.

OBJECTIVE: The aim of the present study is to assess the impact of smoking dose and duration on the distribution of risk factor(s) in patients with RAP and CP, and the impact of genetic testing on the distribution of risk factor(s) in patients with idiopathic RAP and CP. METHODS: All adult patients with RAP and CP referred to a multidisciplinary pancreatitis clinic between 2010 and 2017 were evaluated. Risk factors included alcohol and smoking, hypertriglyceridemia, biliary, and other etiologies. Genetic testing was only pursued in patients with idiopathic RAP or CP. RESULTS: Among the 1770 patients evaluated, 167 had RAP and 303 had CP. After genetic testing and smoking, the most common risk factors for RAP and CP were pathogenic variant(s) (23%) and the combination of alcohol and smoking (23%), respectively. Genetic testing and smoking assessment decreased the proportion of patients with alcoholic RAP from 17% to 5%, alcoholic CP from 33% to 10%, idiopathic RAP from 49% to 12%, and idiopathic CP from 54% to 14%. Pathogenic CFTR variants were the most common variant in patients with RAP (51%) and CP (43%). Among the 68 patients with pancreas divisum, other risk factor(s) were identified in 72%. CONCLUSION: Genetic testing and a detailed assessment of smoking dose and duration reduce the proportion of patients with alcoholic and idiopathic pancreatitis. Other risk factor(s) for pancreatitis are found in the majority of patients with pancreas divisum further questioning its role as an independent risk factor.1. What is the current knowledge?Approximately 30% of patients with pancreatitis have no clear risk factor(s) and are categorized as having an idiopathic etiology.Pathogenic variant(s) as well as smoking dose and duration are well-established risk factors for recurrent acute and chronic pancreatitis but are not widely recognized or incorporated into clinical practice.2. What is new here?Genetic testing and a detailed assessment of smoking dose and duration reduced the proportion of patients with alcoholic and idiopathic acute recurrent and chronic pancreatitis.Approximately three-fourths of patients with pancreas divisum have a risk factor for pancreatitis.

Maximizing success in single-session EUS-directed transgastric ERCP: a retrospective cohort study to identify predictive factors of stent migration.

BACKGROUND AND AIMS: EUS-directed transgastric ERCP (the EDGE procedure) is a simplified method of performing ERCP in Roux-en-Y gastric bypass patients. The EDGE procedure involves placement of a lumen-apposing metal stent (LAMS) into the excluded stomach to serve as a conduit for passage of the duodenoscope for pancreatobiliary intervention. Originally a multistep process, urgent indications for ERCP have led to the development of single-session EDGE (SS-EDGE) with LAMS placement and ERCP performed in the same session. The goal of this study was to identify predictive factors of intraprocedural LAMS migration in SS-EDGE. METHODS: We conducted a multicenter retrospective review that included 9 tertiary medical centers across the United States. Data were collected and analyzed from 128 SS-EDGE procedures. The primary outcome was intraprocedural LAMS migration. Secondary outcomes were other procedural adverse events such as bleeding and perforation. RESULTS: Eleven LAMS migrations were observed in 128 procedures (8.6%). Univariate analysis of clinically relevant variables was performed, as was a binary logistic regression analysis of stent diameter and stent dilation. This revealed that use of a smaller (15 mm) diameter LAMS was an independent predictor of intraprocedural stent migration (odds ratio, 5.36; 95% confidence interval, 1.29-22.24; P = .021). Adverse events included 3 patients who required surgery and 2 who experienced intraprocedural bleeding. CONCLUSIONS: Use of a larger-diameter LAMS is a predictive factor for a nonmigrated stent and improved procedural success in SS-EDGE. Although larger patient cohorts are needed to adequately assess these findings, performance of LAMS dilation and fixation may also decrease risk of intraprocedural LAMS migration and improve procedural success.

Low Serum Trypsin Levels Predict Deep Pancreatic Cannulation Failure During Endoscopic Retrograde Cholangiopancreatography in Patients With Symptomatic Obstructive Chronic Pancreatitis.

OBJECTIVES: Deep pancreatic cannulation (DPC) failure during endoscopic retrograde cholangiopancreatography (ERCP) in patients with chronic pancreatitis (CP) can occur in the presence of ductal obstruction due to strictures and/or stones. There are currently no simple preprocedure clinical or laboratory tests that can predict DPC failure during ERCP. METHODS: All adult patients with definite CP by M-ANNHEIM criteria referred to the pancreatitis clinic between 2010 and 2017 were evaluated. Serum trypsin levels were obtained to assess the morphologic severity of disease and/or exocrine insufficiency. Univariable and multivariable logistic regression analyses were performed to identify factors associated with DPC failure. RESULTS: There were 346 patients, of whom 100 underwent trypsin measurements and ERCP for symptomatic CP. Deep pancreatic cannulation failure occurred in 32 (32%). There were no significant differences with regard to age, sex, etiology, smoking, and alcohol use. Deep pancreatic cannulation failure was more likely to occur in patients with low trypsin levels (53.1% vs 25%, P = 0.007) compared with those with successful DPC. Low trypsin levels were independently associated with DPC failure in adjusted analysis (odds ratio, 3.7; 95% confidence interval, 1.2-11; P = 0.02). CONCLUSIONS: Low serum trypsin levels independently predict DPC failure during ERCP in patients with symptomatic obstructive CP.

Prevalence of positive QuantiFERON gold in-tube testing in hidradenitis suppurativa.

AIM: Hidradenitis suppurativa (HS) is a chronic, recurrent, inflammatory disease of the apocrine sweat glands. Tumor necrosis factor-alpha (TNF-α) inhibitors are commonly used to treat HS. However, prior to initiating therapy patients must be screened for mycobacterium tuberculosis (mTB) exposure. Several mTB screening tests based on interferon gamma release assays are commercially available, but the performance of these assays in the HS population is unknown. The purpose of this study was to investigate the performance of the QuantiFERON gold in-tube assay (QFT-GIT) in a cohort of patients with HS. METHODS: This prospective study was conducted through the Wound Etiology and Healing (WE-HEAL) study. QFTGIT testing was performed using a commercial laboratory. Patients with positive test results underwent follow-up testing to evaluate for latent tuberculosis infection (LTBI). Data were collected on demographics and disease activity scores including Hurley stage, HS Sartorius score (HSS) and active nodule (AN) count. RESULTS: Of the 69 patients with a confirmed diagnosis of HS, seven (10.1%) tested QFT-GIT positive and 5.8% were diagnosed with LTBI. CONCLUSIONS: QFT-GIT results did not correlate with demographic characteristics or HS disease activity.

Clinical and Pathological Risk Factors Associated with Liver Fibrosis and Steatosis in African-Americans with Chronic Hepatitis C.

BACKGROUND AND AIM: Several factors involved in the development of liver fibrosis in African-American patients with chronic hepatitis C have not been well studied. We aimed to evaluate some of these risk factors. METHODS: We reviewed pathology and medical records of 603 African-Americans with chronic hepatitis C virus (HCV) infection at Howard University Hospital from January 2004 to December 2013. Among the clinical and pathological data collected were HIV (human immunodeficiency virus), HCV genotype, hepatitis B virus (HBV), diabetes mellitus (DM), hypertension (HTN), body mass index (BMI), and hepatic steatosis. RESULTS: The frequency of DM, HTN, HIV, and HBV was 22, 16, 11, and 4%, respectively. Median BMI was 27.3 kg/m2. The frequency of fibrosis stages 0, 1, 2, 3, and 4 was 2, 48, 28, 11, and 11%, respectively. In multivariate logistic regression, we found a significant association between liver fibrosis stage (3-4 vs. 0-2) and HIV infection (OR 2.4, P = 0.026), HTN (OR 3.0, P = 0.001), age (OR 2.6 for every 10 years, P < 0.001), weight (OR 1.1 for every 10 lb increase, P = 0.002), and steatosis grade (OR 1.6, P = 0.002). The frequency of liver steatosis was 73%. In an ordinal logistic regression, significant risk factors for steatosis were female gender (OR 1.5, P = 0.034) and inflammation grade (P = 0.001). CONCLUSION: This study shows that steatosis is independently associated with fibrosis in African-American patients with HCV infection. Female patients were at higher risk of steatosis.