Shortening of treatment duration in patients with chronic hepatitis C genotype 2 and 3 - impact of ribavirin dose - a randomized multicentre trial

<p>Abstract</p> <p>Background</p> <p>Chronic hepatitis C (CHC) Patients, infected with genotype (GT) 2 or 3 are treated with Peg-IFN and ribavirin (RBV) (800 mg/day) for 24 weeks. Treatment duration can be shortened to 12-16 weeks if a higher dose of RBV (1.000/1.200 mg/day) was used without considerable loss of responsiveness or increased risk of relapse. Previously we have shown that in patients with CHC, GT 2/3 RBV can be reduced to 400 mg/day if administered for 24 weeks without an increase in relapse rates. Therefore we investigated the efficacy of a reduced RBV dosage of 400 mg/day with shorter treatment duration (16 weeks).</p> <p>Methods</p> <p>Treatment naïve patients with CHC, GT 2/3 were randomized to receive 180 μg peginterferonα2a/week in combination with either 800 (group C) or 400 mg/d (group D) for 16 weeks. The primary endpoint was SVR.</p> <p>Results</p> <p>12 months after the first patient was randomized a inferior outcome of group D as compared to group C was noted, therefore the study was terminated. At study termination 89 patients were enrolled (group C: 31, D: 51). The SVR rate was statistically different in the two study groups with 51.6% in group C and 28.4% in group D (p = 0.038). Patients with low viral load had higher SVR rates (C: 67%, D: 33%) than those with high viral load (C: 33%, D: 21%).</p> <p>Conclusion</p> <p>Both treatment duration and the dose of RBV play a major role to optimize outcome of patients with GT3. If one intends to shorten the treatment weight based RBV dose should be used, if lower RBV doses are used patients should be treated for at least 24 weeks as. A treatment regimen with a reduced RBV dosage and shortened treatment duration is associated with low SVR rates due to high relapse rates.</p> <p>Trial registration</p> <p><a href="http://www.clinicaltrials.gov/ct2/show/NCT01258101">NCT01258101</a></p

SASE, Success and Adverse event Score in Endoscopic Retrograde Cholangiopancreatography: a Novel Grading System

Abstract Background Validated, accepted grading tools for preprocedural complexity assessment in ERCP are lacking. We therefore created a grading system for ERCP based on the classification used by the American Society for Gastrointestinal Endoscopy (ASGE). Methods Data on ERCP adverse events (AE) and success were collected in a multicenter, prospective uncontrolled study. Multiple logistic regressions were applied to success and AEs in accordance with the ASGE classification. Each procedure suggested by ASGE was tested against different outcomes. Results were used to create a score and were evaluated in a control cohort. Results 16,327 ERCPs were documented in 27 centers. Analysis of ASGE categorization (10,904 cases) showed that this model fails to adequately predict parameters of complexity; only for cardiopulmonary AEs and perforation was no significant variance evident. Depending on the specific clinical circumstances, probability of success of the intervention sometimes varied significantly in risk, implying a twofold score, one part for probability of success and one for risk. A split score with three levels each was designed and tested in a validation cohort (5,423 procedures). Achieving therapeutic targets / post-ERCP pancreatitis could be correctly predicted in 87.0%/95.3%. Conclusions Grading ERCP success and AEs have to be considered independently. Onefold grading systems appear incomplete and unable to provide an adequate classification of severity. SASE (Success and Adverse Event Score in Endoscopic Retrograde Cholangiopancreatography) was created to incorporate these findings. Showing high predictive value, this score could be a potent tool for planning ERCP and training in endoscopy

REAL-Colon: A dataset for developing real-world AI applications in colonoscopy

Abstract Detection and diagnosis of colon polyps are key to preventing colorectal cancer. Recent evidence suggests that AI-based computer-aided detection (CADe) and computer-aided diagnosis (CADx) systems can enhance endoscopists' performance and boost colonoscopy effectiveness. However, most available public datasets primarily consist of still images or video clips, often at a down-sampled resolution, and do not accurately represent real-world colonoscopy procedures. We introduce the REAL-Colon (Real-world multi-center Endoscopy Annotated video Library) dataset: a compilation of 2.7 M native video frames from sixty full-resolution, real-world colonoscopy recordings across multiple centers. The dataset contains 350k bounding-box annotations, each created under the supervision of expert gastroenterologists. Comprehensive patient clinical data, colonoscopy acquisition information, and polyp histopathological information are also included in each video. With its unprecedented size, quality, and heterogeneity, the REAL-Colon dataset is a unique resource for researchers and developers aiming to advance AI research in colonoscopy. Its openness and transparency facilitate rigorous and reproducible research, fostering the development and benchmarking of more accurate and reliable colonoscopy-related algorithms and models

The VITRO Score (Von Willebrand Factor Antigen/Thrombocyte Ratio) as a New Marker for Clinically Significant Portal Hypertension in Comparison to Other Non-Invasive Parameters of Fibrosis Including ELF Test

<div><p>Background</p><p>Clinically significant portal hypertension (CSPH), defined as hepatic venous pressure gradient (HVPG) ≥10 mmHg, causes major complications. HVPG is not always available, so a non-invasive tool to diagnose CSPH would be useful. VWF-Ag can be used to diagnose. Using the VITRO score (the VWF-Ag/platelet ratio) instead of VWF-Ag itself improves the diagnostic accuracy of detecting cirrhosis/ fibrosis in HCV patients.</p><p>Aim</p><p>This study tested the diagnostic accuracy of VITRO score detecting CSPH compared to HVPG measurement.</p><p>Methods</p><p>All patients underwent HVPG testing and were categorised as CSPH or no CSPH. The following patient data were determined: CPS, D’Amico stage, VITRO score, APRI and transient elastography (TE).</p><p>Results</p><p>The analysis included 236 patients; 170 (72%) were male, and the median age was 57.9 (35.2–76.3; 95% CI). Disease aetiology included ALD (39.4%), HCV (23.4%), NASH (12.3%), other (8.1%) and unknown (11.9%). The CPS showed 140 patients (59.3%) with CPS A; 56 (23.7%) with CPS B; and 18 (7.6%) with CPS C. 136 patients (57.6%) had compensated and 100 (42.4%) had decompensated cirrhosis; 83.9% had HVPG ≥10 mmHg. The VWF-Ag and the VITRO score increased significantly with worsening HVPG categories (P<0.0001). ROC analysis was performed for the detection of CSPH and showed AUC values of 0.92 for TE, 0.86 for VITRO score, 0.79 for VWF-Ag, 0.68 for ELF and 0.62 for APRI.</p><p>Conclusion</p><p>The VITRO score is an easy way to diagnose CSPH independently of CPS in routine clinical work and may improve the management of patients with cirrhosis.</p></div

Correlation of aspartate aminotransferase to platelet ratio index (APRI) and CSPH.

<p>Mean values of APRI shown in boxplots for a cohort of patients with and without CSPH each.</p

ROC analysis shows the ability of aspartate aminotransferase to platelet ratio index (APRI) predicting clinically significant portal hypertension (CSPH).

<p>ROC analysis showing the diagnostic ability of APRI detecting CSPH with an AUC of 0.62.</p

ROC analysis shows the ability of transient elastography (TE) predicting clinically significant portal hypertension (CSPH).

<p>ROC analysis showing the diagnostic ability of TE detecting CSPH with an AUC of 0.92.</p

Demographic characteristics of patients with cirrhosis (n = 236).

<p>Demographic characteristics of patients with cirrhosis (n = 236).</p