Comparison of Cap-Assisted vs Conventional Endoscopic Technique for Management of Food Bolus Impaction in the Esophagus: Results of a Multicenter Randomized Controlled Trial.

INTRODUCTION: "Push" or "pull" techniques with the use of snares, forceps, baskets, and grasping devices are conventionally used to manage esophageal food bolus impaction (FBI). A novel cap-assisted technique has recently been advocated to reduce time taken for food bolus (FB) removal. This study aimed to compare the effectiveness of the cap-assisted technique against conventional methods of esophageal FB removal in a randomized controlled trial. METHODS: Consecutive patients with esophageal FBI requiring endoscopic removal, from 3 Australian tertiary hospitals between 2017 and 2019, were randomized to either the cap-assisted technique or the conventional technique. Primary outcomes were technical success and FB retrieval time. Secondary outcomes were technical success rate, en bloc removal rate, procedure-related complication, length of hospital stay, and cost of consumables. RESULTS: Over 24 months, 342 patients with esophageal FBI were randomized to a cap-assisted (n = 171) or conventional (n = 171) technique. Compared with the conventional approach, the cap-assisted technique was associated with (i) shorter FB retrieval time (4.5 ± 0.5 minutes vs 21.7 ± 0.9 minutes, P < 0.001), (ii) shorter total procedure time (23.0 ± 0.6 minutes vs 47.0 ± 1.3 minutes, P < 0.0001), (iii) higher technical success rate (170/171 vs 160/171, P < 0.001), (iv) higher rate of en bloc removal (159/171 vs 48/171, P < 0.001), and (v) lower rate of procedure-related mucosal tear and bleeding (0/171 vs 13/171, P < 0.001). There were no major adverse events or deaths within 30 days in either group. The total cost of consumables was higher in the conventional group (A$19,644.90 vs A$6,239.90). DISCUSSION: This multicenter randomized controlled trial confirmed that the cap-assisted technique is more effective and less costly than the conventional approach and should be first-line treatment for esophageal FBI.

Cost effectiveness of treatment models of care for hepatitis C: the South Australian state-wide experience.

AIM: The objective was to study the long-term (lifetime) cost effectiveness of four different hepatitis C virus (HCV) treatment models of care (MOC) with directly acting antiviral drugs. METHODS: A cohort Markov model-based probabilistic cost-effectiveness analysis (CEA) was undertaken extrapolating to up to 30 years from cost and outcome data collected from a primary study involving a real-life Australian cohort. In this study, noncirrhotic patients treated for HCV from 1 March 2016 to 28 February 2017 at four major public hospitals and liaising sites in South Australia were studied retrospectively. The MOC were classified depending on the person providing patient workup, treatment and monitoring into MOC1 (specialist), MOC2 (mixed specialist and hepatitis nurse), MOC3 (hepatitis nurse) and MOC4 (general practitioner, GP). Incremental costs were estimated from the Medicare perspective. Incremental outcomes were estimated based on the quality-adjusted life years (QALY) gained by achieving a sustained virological response. A cost-effectiveness threshold of Australian dollar 50 000 per QALY gained, the implicit criterion used for assessing the cost-effectiveness of new pharmaceuticals and medical services in Australia was assumed. Net monetary benefit (NMB) estimates based on this threshold were calculated. RESULTS: A total of 1373 patients, 64% males, mean age 50 (SD ±11) years, were studied. In the CEA, MOC4 and MOC2 clearly dominated MOC1 over 30 years with lower costs and higher QALYs. Similarly, NMB was the highest in MOC4, followed by MOC2. CONCLUSION: Decentralized care using GP and mixed consultant nurse models were cost-effective ways of promoting HCV treatment uptake in the setting of unrestricted access to new antivirals.

Use of aspartate aminotransferase to platelet ratio to reduce the need for FibroScan in the evaluation of liver fibrosis.

AIM: To evaluate the performance of aspartate aminotransferase to platelet ratio (APRI) score against FibroScan in predicting the presence of fibrosis. METHODS: Data of patients who concurrently had APRI score, FibroScan and liver biopsy to assess their hepatitis C virus (HCV) and hepatitis B virus (HBV) over 6 years were retrospectively reviewed and details of their disease characteristics and demographics were recorded. Advanced fibrosis was defined as ≥ F3. RESULTS: Of the 3619 patients (47.5 ± 11.3 years, 97M:36F) who had FibroScans and APRI for HCV and HBV, 133 had concurrent liver biopsy. Advanced liver fibrosis was found in 27/133 (20%, F3 = 21 and F4 = 6) patients. Although APRI score (P < 0.001, AUC = 0.83) and FibroScan (P < 0.001, AUC = 0.84) predicted the presence of advanced fibrosis, the sensitivities and specificities were only modest (APRI score: 51.9% sensitivity, 84.9% specificity; FibroScan: 63% sensitivity, 84% specificity). Whilst 13/27 (48%) patients with advanced fibrosis had APRI ≤ 1.0, no patients with APRI ≤ 0.5 had advanced fibrosis, with 100% sensitivity. The use of APRI ≤ 0.5 would avoid the need for FibroScan in 43% of patients. CONCLUSION: APRI score and FibroScan performed equally well in predicting advanced fibrosis. A proposed APRI cut-off score of 0.5 could be used as a screening tool for FibroScan, as cut-off score of 1.0 will miss up to 48% of patients with advanced fibrosis. Further prospective validation studies are required to confirm this finding.

Patient Age, Sex, and Inflammatory Bowel Disease Phenotype Associate With Course of Primary Sclerosing Cholangitis.

BACKGROUND & AIMS: Primary sclerosing cholangitis (PSC) is an orphan hepatobiliary disorder associated with inflammatory bowel disease (IBD). We aimed to estimate the risk of disease progression based on distinct clinical phenotypes in a large international cohort of patients with PSC. METHODS: We performed a retrospective outcome analysis of patients diagnosed with PSC from 1980 through 2010 at 37 centers in Europe, North America, and Australia. For each patient, we collected data on sex, clinician-reported age at and date of PSC and IBD diagnoses, phenotypes of IBD and PSC, and date and indication of IBD-related surgeries. The primary and secondary endpoints were liver transplantation or death (LTD) and hepatopancreatobiliary malignancy, respectively. Cox proportional hazards models were applied to determine the effects of individual covariates on rates of clinical events, with time-to-event analysis ascertained through Kaplan-Meier estimates. RESULTS: Of the 7121 patients in the cohort, 2616 met the primary endpoint (median time to event of 14.5 years) and 721 developed hepatopancreatobiliary malignancy. The most common malignancy was cholangiocarcinoma (n = 594); patients of advanced age at diagnosis had an increased incidence compared with younger patients (incidence rate: 1.2 per 100 patient-years for patients younger than 20 years old, 6.0 per 100 patient-years for patients 21-30 years old, 9.0 per 100 patient-years for patients 31-40 years old, 14.0 per 100 patient-years for patients 41-50 years old, 15.2 per 100 patient-years for patients 51-60 years old, and 21.0 per 100 patient-years for patients older than 60 years). Of all patients with PSC studied, 65.5% were men, 89.8% had classical or large-duct disease, and 70.0% developed IBD at some point. Assessing the development of IBD as a time-dependent covariate, Crohn's disease and no IBD (both vs ulcerative colitis) were associated with a lower risk of LTD (unadjusted hazard ratio [HR], 0.62; P < .001 and HR, 0.90; P = .03, respectively) and malignancy (HR, 0.68; P = .008 and HR, 0.77; P = .004, respectively). Small-duct PSC was associated with a lower risk of LTD or malignancy compared with classic PSC (HR, 0.30 and HR, 0.15, respectively; both P < .001). Female sex was also associated with a lower risk of LTD or malignancy (HR, 0.88; P = .002 and HR, 0.68; P < .001, respectively). In multivariable analyses assessing the primary endpoint, small-duct PSC characterized a low-risk phenotype in both sexes (adjusted HR for men, 0.23; P < .001 and adjusted HR for women, 0.48; P = .003). Conversely, patients with ulcerative colitis had an increased risk of liver disease progression compared with patients with Crohn's disease (HR, 1.56; P < .001) or no IBD (HR, 1.15; P = .002). CONCLUSIONS: In an analysis of data from individual patients with PSC worldwide, we found significant variation in clinical course associated with age at diagnosis, sex, and ductal and IBD subtypes. The survival estimates provided might be used to estimate risk levels for patients with PSC and select patients for clinical trials.

Ultrathin disposable gastroscope for screening and surveillance of gastroesophageal varices in patients with liver cirrhosis: a prospective comparative study.

BACKGROUND AND AIMS: This study aims to evaluate the role of unsedated, ultrathin disposable gastroscopy (TDG) against conventional gastroscopy (CG) in the screening and surveillance of gastroesophageal varices (GEVs) in patients with liver cirrhosis. METHOD: Forty-eight patients (56.4 ± 1.3 years; 38 male, 10 female) with liver cirrhosis referred for screening (n = 12) or surveillance (n = 36) of GEVs were prospectively enrolled. Unsedated gastroscopy was initially performed with TDG, followed by CG with conscious sedation. The 2 gastroscopies were performed by different endoscopists blinded to the results of the previous examination. Video recordings of both gastroscopies were validated by an independent investigator in a random, blinded fashion. Endpoints were accuracy and interobserver agreement of detecting GEVs, safety, and potential cost saving. RESULTS: CG identified GEVs in 26 (54%) patients, 10 of whom (21%) had high-risk esophageal varices (HREV). Compared with CG, TDG had an accuracy of 92% for the detection of all GEVs, which increased to 100% for high-risk GEVs. The interobserver agreement for detecting all GEVs on TDG was 88% (κ = 0.74). This increased to 94% (κ = 0.82) for high-risk GEVs. There were no serious adverse events. CONCLUSIONS: Unsedated TDG is safe and has high diagnostic accuracy and interobserver reliability for the detection of GEVs. The use of clinic-based TDG would allow immediate determination of a follow-up plan, making it attractive for variceal screening and surveillance programs. (Clinical trial (ANZCTR) registration number: ACTRN12616001103459.).