Quality of Tissue Samples Obtained by Endoscopic Ultrasound-Guided Liver Biopsy: A Randomized, Controlled Clinical Trial.

INTRODUCTION: Liver biopsy (LB) remains essential for the diagnosis and staging of parenchymal liver diseases. Endoscopic ultrasound-guided LB (EUS-LB) has emerged as an attractive alternative to percutaneous and transjugular routes. We aimed at comparing the adequacy of samples obtained by EUS-LB with percutaneous LB. METHODS: A single-center, randomized, controlled clinical trial was designed. Patients undergoing LB were randomly assigned to EUS-LB or percutaneous LB groups. EUS-LB was performed with a 19-gauge Franseen core needle through a transduodenal and transgastric route. Percutaneous LB was performed with a 16-gauge Tru-Cut needle. The main outcome was the percentage of adequate samples obtained. Secondary outcomes were the percentage of accurate histologic diagnosis, number of complete portal tracts (CPT), total and longest specimen length (TSL and LSL), sample fragmentation, adverse events, and patients' satisfaction. An adequate specimen was defined as TSL ≥20 mm and including ≥11 CPT. RESULTS: Ninety patients were randomized (44 to EUS-LB and 46 to percutaneous LB) and included in the analysis. The percentage of adequate tissue samples was 32.6% and 70.4% for percutaneous LB and EUS-LB, respectively ( P < 0.001). A final histologic diagnosis was provided in all cases but one. TSL was longer after EUS-LB (23.5 vs 17.5 mm, P = 0.01), whereas the number of CPT was similar in both groups. Sample fragmentation occurred more often after EUS-LB ( P < 0.001). No differences in adverse events were found. Satisfaction reported with both procedures was high. DISCUSSION: EUS-LB is safe and accurate and may be considered an alternative to percutaneous LB for the evaluation of parenchymal liver diseases.

Non-pharmacologic direct cost of a simplified strategy with glecaprevir/pibrentasvir for 8 weeks in naïve non-cirrhotic patients with hepatitis C implemented in clinical practice. The Just SIMPLE Study.

BACKGROUND AND OBJECTIVE: The emergence of highly tolerable, effective, and shorter duration direct-acting antivirals (DAAs) regimens offers the opportunity to simplify hepatitis C virus management but medical costs are unknown. Thus, we aimed to determine the direct medical costs associated with a combo-simplified strategy (one-step diagnosis and low monitoring) to manage HCV infection within an 8-week glecaprevir/pibrentasvir (GLE/PIB) regimen in clinical practice in Spain. PATIENTS AND METHODS: Healthcare resources and clinical data were collected retrospectively from medical charts of 101 eligible patients at 11 hospitals. Participants were adult, treatment naïve subjects with HCV infection without cirrhosis in whom a combo-simplified strategy with GLE/PIB for 8 weeks were programmed between Apr-2018 and Nov-2018. RESULTS: The GLE/PIB effectiveness was 100% (CI95%: 96.2-100%) in the mITT population and 94.1% (CI95%: 87.5-97.8%) in the ITT population. Three subjects discontinued the combo-simplified strategy prematurely, none of them due to safety reasons. Five subjects reported 8 adverse events, all of mild-moderate intensity. Combo-simplified strategy mean direct costs were 754.35±103.60€ compared to 1689.42€ and 2007.89€ of a theoretical 12-week treatment with 4 or 5 monitoring visits, respectively; and 1370.95€ and 1689.42€ of a theoretical 8-week with 3 or 4 monitoring visits, respectively. Only 4.9% of the subjects used unexpected health care resources. CONCLUSIONS: 8-week treatment with GLE/PIB combined with a combo simplified strategy in real-life offers substantial cost savings without affecting the effectiveness and safety compared to traditional approaches.

Pancreatic exocrine insufficiency and cardiovascular risk in patients with chronic pancreatitis: A prospective, longitudinal cohort study.

BACKGROUND AND AIM: Previous studies have suggested that chronic pancreatitis (CP) is associated with increased risk of cardiovascular (CV) disease independently of other major risk factors. We evaluated the risk of CV events in a well-phenotyped cohort of patients with CP and its association with pancreatic exocrine insufficiency (PEI) among other CV risk factors. METHODS: This was a prospective, longitudinal cohort study of patients with CP, followed up at the Pancreas Unit of the University Hospital of Santiago de Compostela, Spain. RESULTS: Four hundred thirty patients were included (mean 47.8 ± 14.4 years of age, 79.1% male). Mean follow-up was 8.6 ± 4.6 years. CP etiology was toxic (alcohol and/or smoking) in 290 patients (67.4%). PEI and pancreatogenic diabetes mellitus (DM) were present in 29.3% and 29.5% of the patients, respectively. A total of 45 CV events was recorded (10.5%); 21 patients had a major CV event (stroke or myocardial infarction) and 27 developed clinically relevant peripheral arterial disease. A higher incidence of CV events was recorded in patients with PEI than in those without (incidence rate ratio 3.67, 95% confidence interval [CI] 1.92-7.24; P < 0.001). In the multivariate analysis, PEI without DM (OR 4.96; 95% CI 1.68 to 14.65), coexistence of PEI and DM (OR 6.54; 95% CI 2.71 to 15.77), arterial hypertension (OR 3.40; 95% CI 1.50 to 7.72), and smoking (OR 2.91, 95% CI 1.07 to 7.97) were independently associated with increased CV risk. CONCLUSIONS: Together with known major CV risk factors like smoking and hypertension, PEI is significantly associated with the risk of CV events in patients with CP.

Increased Risk of Mortality Associated With Pancreatic Exocrine Insufficiency in Patients With Chronic Pancreatitis.

BACKGROUND: Pancreatic exocrine insufficiency (PEI) is a common serious complication in chronic pancreatitis (CP); however, little is known about its effect on mortality in these patients. In this study, we assessed the mortality risk of PEI in patients with CP. STUDY: A prospective, longitudinal cohort study conducted in patients with CP under long-term follow-up. CP and PEI were diagnosed using pancreatic imaging and the C-labeled mixed triglyceride breath test, respectively. Multivariate analysis was performed to evaluate the impact of PEI and other clinical features on mortality risk. RESULTS: Patients (N=430) were analyzed (79.1% male; mean age, 47.8 y) during a mean follow-up of 8.6±4.6 years. PEI prevalence was 29.3% and mortality was 10.9%. Most frequent causes of death were cancer (40.4%), infection (21.3%), and acute cardiovascular event (14.9%). Multivariate analyses showed associations between increased mortality and presence of PEI [hazard ratio (HR), 2.59; 95% confidence interval (CI), 1.42-4.71; P<0.003], liver cirrhosis (HR, 3.87; 95% CI, 1.95-7.69; P<0.001), age at diagnosis (HR, 1.05; 95% CI, 1.03-1.09; P<0.001), toxic etiology of CP (HR, 3.11; 95% CI, 1.11-8.70; P<0.05) and respiratory comorbidity (HR, 2.19; 95% CI, 1.12-4.31; P<0.03). Nutritional markers were significantly lower in patients with PEI versus those without PEI (P<0.001) and in those who died versus survivors (P<0.001). CONCLUSIONS: PEI was a significant independent risk factor for mortality in patients with CP. These results support further research into the optimal treatment of PEI to reduce mortality in this population.

Feasibility of endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and biopsy (FNB) with a new slim linear echoendoscope.

BACKGROUND: Endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and biopsy (FNB) is considered a very accurate and safe tool for sampling extra-intestinal tumors. Standard echoendosocopes for FNA/FNB are large with a sharpened tip that can be associated with complications. A new slim linearechoendoscope have been developed trying to overcome this limitation. AIM: Of the present study was to evaluate the feasibility; safety and diagnostic yield of this newly developed slim echoendoscope for performing EUS-guided FNA/FNB. METHODS: A pilot observational study was performed. Consecutive patients submitted for a EUS-FNA/FNB were prospectively included in the study. Patients underwent EUS procedure using the new slim linear PENTAX-echoendoscope. Tissue acquisition was done with standard and histology needles. Feasibility and diagnostic yield were evaluated. A descriptive analysis was performed. RESULTS: 87 patients were included (mean age 66.7 years (range 24-90 years), 45 male. Mean size was of lesions sampled were 33.43 +/- 20.8 mm. Esophagus intubation and access to the second portion of the duodenum (D2) were considered easy in all 87 cases (100%). Nineteen procedures (21.8%) were performed from the esophagus, 42 (48.3%) from the stomach, 22 (25.3%) cases from duodenal bulb, and 4 (4.6%) cases from D2. EUS-FNB was feasible in 85 cases (97.7%), failed in 2 pancreatic lesions accessed from D2. Diagnostic yield was 86.21% (95%CI 77.4- 91.9) in the intention-to-treat analysis and 88.24% (95%CI 79.7- 93.5) in per-protocol analysis. There were no complications related to the technique. CONCLUSION: Performing a EUS-FNA/FNB with the newly designed slim scope is feasible and safe for cyto-histopathology diagnosis of intra-intestinal and extra-intestinal mass lesions.

Cholangitis and multiple liver abscesses after percutaneous ethanol injection (PEI) for recurrent hepatocellular carcinoma (HCC).

Percutaneous ablation procedures are minimally invasive treatments for unresectable early stage hepatocellular carcinoma (HCC). These techniques are usually safe, but rare and even fatal complications have been described. We present a fatal result after percutaneous ethanol injection (PEI) for the treatment of a recurrent HCC in a non-cirrhotic liver, with subsequent development of diffuse cholangitis and multiple liver abscesses. Although percutaneous drainage and intensive antibiotic treatment were employed, the patient finally died. We discuss about the etiology and the physiopathology of this rare complication in which the therapeutic options are limited and usually unsuccessful.