Liver biopsy is required for staging hepatic fibrosis in patients with chronic hepatitis C, but it is an expensive procedure with occasional complications and poor patient acceptance. This cohort ...study was designed to assess the accuracy of a noninvasive method aimed to discriminate between patients with and without significant liver fibrosis (stages 2-4 versus 0-1). Clinically relevant variables were analyzed in a cohort of 476 consecutive untreated patients (estimation group, 351 patients; validation group, 125 patients) with chronic hepatitis C who underwent a liver biopsy. Multivariate analysis identified age, gamma glutamyl transpeptidase (GGT), cholesterol, platelet count, and prothrombin time as independent predictors of fibrosis. We constructed a model and a score system combining age, GGT, cholesterol, and platelet count that proved useful to identify patients without significant hepatic fibrosis. The area under the ROC curve was 0.86 for the estimation group and 0.81 for the validation group. Using the best cutoff score (less than 4.2), presence of significant fibrosis (F2 to F4) could be excluded with high accuracy (negative predictive value of 96%) in 125 (36%) of 351 patients. Similarly, it could be excluded with the same certainty in 49 (39%) of the 125 patients of the validation group. Only 2 patients with liver fibrosis stage 2 were incorrectly classified. In conclusion, a combination of easily accessible variables accurately predicts the absence of significant fibrosis and might render liver biopsy unnecessary in more than one third of patients with chronic hepatitis C. (H
EPATOLOGY 2002;36:986-992.)
Background and Aims
There is controversy about the length of low‐residue diet (LRD) for colonoscopy preparation. The aim of the study was to compare one‐day vs. three‐day LRD associated to standard ...laxative treatment for achieving an adequate colonoscopy preparation in average risk subjects with positive fecal immunochemical test undergoing screening colonoscopy.
Methods
A non‐inferiority, randomized, controlled, parallel‐group clinical trial was performed in the setting of average risk colorectal cancer screening program. Participants were randomized to receive 1‐day vs. 3‐day LRD in addition to standard polyethilenglicol treatment. Adequacy of preparation was evaluated using the Boston Bowel Preparation Scale (BBPS). Primary outcome was achieving a BBPS ≥ 2 in all colon segments. Analysis was performed for a non‐inferiority margin of 5%, a 95% statistical power and one‐sided 0.05 significance level.
Results
A total of 855 patients were randomized. Adequate bowel preparation was similar between groups: 97.9% of patients in the 1‐day LRD group vs 96.9% in the 3‐day LRD group achieved the primary outcome (P‐value for non‐inferiority < 0.001). The percentage of patients with BBPS scores ≥ 8 was superior in the 1‐day LRD group (254 vs 221 in the 3‐day LRD group, P = 0.032). The 1‐day regimen was better tolerated than the 3‐day diet. 47.7% (vs 28.7%, P < 0.05) of patients rated the 1‐day LRD as very easy to follow.
Conclusion
The 1‐day LRD is non‐inferior to 3‐day LRD for achieving an adequate colon cleansing before average risk screening colonoscopy and it is better tolerated.
Background & Aims:
Patients with chronic hepatitis C who do not respond rapidly to therapy have a low chance of developing a sustained virologic response (SVR) when treated for 48 weeks. This study ...investigated whether treatment for 72 weeks increases the rate of SVR in patients with detectable hepatitis C virus (HCV)-RNA levels at week 4 of treatment.
Methods:
A total of 510 treatment-naive patients were treated with peginterferon-alfa2a (180 μg/wk) plus ribavirin (800 mg/day). Patients with detectable HCV-RNA levels at week 4 (n = 326) were randomized to complete 48 (group A, n = 165) or 72 weeks (group B, n = 161) of treatment. Patients with undetectable HCV-RNA levels at week 4 (n = 184) were allocated into group C (n = 148) or group D (n = 36), according to HCV genotype and baseline viremia, and treated for 24 or 48 weeks, respectively. All patients were followed-up for 24 weeks after the end of treatment.
Results:
The end-of-treatment response rate (61%) was similar in groups A and B, but the SVR rate was higher in group B (45% vs 32% in A;
P = .01). In genotype 1–infected patients randomized to group A (n = 149) or B (n = 142), SVR rates were 28% and 44%, respectively (
P = .003). The incidence of adverse events was similar in all groups. Treatment discontinuation was more frequent in group B (36%) than in group A (18%) (
P = .0004). SVR rates in groups C and D were 79% and 64%, respectively.
Conclusions:
Extension of treatment with peginterferon-alfa2a plus ribavirin from 48 to 72 weeks significantly increases the rate of SVR in patients with detectable viremia at week 4 of treatment.
Background/Aims Recurrence of hepatitis C after liver transplantation (LT) is universal and may cause premature graft loss. We evaluated the efficacy and safety of antiviral therapy in HCV-infected ...patients with decompensated cirrhosis awaiting LT. Methods Fifty-one patients underwent treatment with peginterferon-alfa-2a and ribavirin. A control group of 51 untreated individuals awaiting LT were matched by age, Child-Pugh and MELD scores and time on the waiting list. Results Case and control patients were comparable for all relevant variables. Fifteen treated patients (29%) had undetectable HCV-RNA at the time of transplantation and 10 (20%) achieved SVR. Early virological response and non-1 genotype were the strongest predictors of viral clearance. There was a higher incidence of bacterial infections in treated patients vs controls, particularly in Child-Pugh B-C individuals (17 vs 3 episodes) (log-rank = 0.0016). Importantly, the incidence of spontaneous bacterial peritonitis (SBP) in patients who were not receiving norfloxacin prophylaxis ( n = 83) was significantly higher in the treated group than in controls (log-rank = 0.01). Conclusions Our data demonstrate that antiviral treatment prevents hepatitis C recurrence in 20% of HCV-infected patients. However, treatment should be recommended with caution in individuals with poor liver function who do not receive norfloxacin prophylaxis for SBP, since it increases the risk of bacterial infections.
Fast-track colonoscopy to detect patients with colorectal cancer based on high-risk symptoms is associated with low sensitivity and specificity. The aim was to derive a predictive score of advanced ...colonic neoplasia in symptomatic patients in fast-track programs.
All patients referred for fast-track colonoscopy were evaluated. Faecal immunological haemoglobin test (3 samples; positive> 4 μg Hb/g), and a survey to register clinical variables of interest were performed. Colorectal cancer and advanced adenoma were considered as advanced colonic neoplasia. A sample size of 600 and 500 individuals were calculated for each phase 1 and phase 2 of the study, respectively (Phase 1, derivation and Phase 2, validation cohort). A Bayesian logistic regression analysis was used to derive a predictive score.
1495 patients were included. Age (OR, 21), maximum faecal-Hb value (OR, 2.3), and number of positive samples (OR, 28) presented the highest ORs predictive of advanced colonic neoplasia. The additional significant predictive variables adjusted for age and faecal-Hb variables in Phase 1 were previous colonoscopy (last 5 years) and smoking (no, ex/active). With these variables a predictive score of advanced colonic neoplasia was derived. Applied to Phase 2, patients with a Score > 20 had an advanced colonic neoplasia probability of 66% (colorectal cancer, 32%), while those with a Score ≤ 10, a probability of 10% (colorectal cancer, 1%). Prioritizing patients with Score > 10, 49.4% of patients would be referred for fast-track colonoscopy, diagnosing 98.3% of colorectal cancers and 77% of advanced adenomas.
A scoring system was derived and validated to prioritize fast-track colonoscopies according to risk, which was efficient, simple, and robust.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Immunochromatographic tests need to be improved in order to enhance their reliability. Recently, several new kits have appeared on the market. The objective was to evaluate the diagnostic accuracy of ...three monoclonal rapid stool tests – the new Uni-Gold™ H.pylori Antigen (Trinity Biotech, Ireland), the RAPID Hp StAR (Oxoid Ltd., UK) and the ImmunoCard STAT! HpSA (Meridian Diagnostics, USA) – for detecting H. pylori infection prior to eradication treatment.
Diagnostic accuracy (sensitivity and specificity) and reliability (concordance between observers) were evaluated in 250 untreated consecutive dyspeptic patients. The gold standard for diagnosing H. pylori infection was defined as the concordance of two or more of rapid urease test (RUT), histopathology and urease breath test (UBT) or positive culture in isolation. Readings of immunochromatographic tests were performed by two different observers. Sensitivity, specificity, positive and negative predictive values and 95% confidence intervals were calculated. Sensitivity and specificity were compared using the McNemar test.
The three tests showed a good correlation, with Kappa values>0.9. RAPID Hp StAR had a sensitivity of 91%–92% and a specificity ranging from 77% to 85%. Its sensitivity was higher than that of Uni-Gold™ H.pylori Antigen and ImmunoCard STAT! HpSA (p<0.01). Uni-Gold™ H.pylori Antigen kit showed a sensitivity of 83%, similar to ImmunoCard STAT! HpSA. Specificity of Uni-Gold™ H.pylori Antigen approached 90% (87–89%) and was superior to that of RAPID Hp StAR (p<0.01).
Uni-Gold™ H.pylori Antigen and ImmunoCard STAT! HpSA present similar levels of diagnostic accuracy. RAPID Hp StAR was the most sensitive but less reliable of the three immunochromatographic stool tests. None are as accurate and reliable as UBT, RUT and histology.
Background/Aims Isolated cases of acute hepatitis C, as well as hepatitis C outbreaks transmitted by health-care related procedures, have drawn attention to nosocomial transmission of HCV. The aim of ...this study was to investigate the current relevance of nosocomial HCV infection. Methods For this purpose, we performed a retrospective epidemiological analysis of all cases of acute hepatitis C diagnosed in 18 Spanish hospitals. Between 1998 and 2005, 109 cases were documented. Results The most relevant risk factors registered during the 6-month period preceding the diagnosis of acute hepatitis C were: hospital admission in 73 (67%) cases, intravenous drug use in 9 (8%), accidental needlestick injury in 7 (6%) and sexual contact in 6 (5%). Among the 73 patients in whom hospital admission was the only risk factor, 33 underwent surgery and 24 were admitted to a medical emergency unit or a medical ward; the remaining 16 patients underwent an invasive diagnostic or therapeutic procedure. Sixty two patients underwent antiviral therapy and 51 (82%) achieved a sustained virological response. In 47 patients treatment was not indicated (in 24 due to spontaneous resolution of HCV infection). Conclusions In most patients with acute hepatitis C the only documented risk factor associated with the infection is hospital admission. These results stress the need for strict adherence to universal precaution measures. Fortunately, most cases of acute hepatitis C either resolve spontaneously or after antiviral therapy.
Faecal immunochemical test (FIT) has been recommended to assess symptomatic patients for colorectal cancer (CRC) detection. Nevertheless, some conditions could theoretically favour blood originating ...in proximal areas of the gastrointestinal tract passing through the colon unmetabolized. A positive FIT result could be related to other gastrointestinal cancers (GIC).
To assess the risk of GIC detection and related death in FIT-positive symptomatic patients (threshold 10 μg Hb/g faeces) without CRC.
Post hoc cohort analysis performed within two prospective diagnostic test studies evaluating the diagnostic accuracy of different FIT analytical systems for CRC and significant colonic lesion detection. Ambulatory patients with gastrointestinal symptoms referred consecutively for colonoscopy from primary and secondary healthcare, underwent a quantitative FIT before undergoing a complete colonoscopy. Patients without CRC were divided into two groups (positive and negative FIT) using the threshold of 10 μg Hb/g of faeces and data from follow-up were retrieved from electronic medical records of the public hospitals involved in the research. We determined the cumulative risk of GIC, CRC and upper GIC. Hazard rate (HR) was calculated adjusted by age, sex and presence of significant colonic lesion.
We included 2709 patients without CRC and a complete baseline colonoscopy, 730 (26.9%) with FIT ≥ 10 µgr Hb/gr. During a mean time of 45.5 ± 20.0 mo, a GIC was detected in 57 (2.1%) patients: An upper GIC in 35 (1.3%) and a CRC in 14 (0.5%). Thirty-six patients (1.3%) died due to GIC: 22 (0.8%) due to an upper GIC and 9 (0.3%) due to CRC. FIT-positive subjects showed a higher CRC risk (HR 3.8, 95%CI: 1.2-11.9) with no differences in GIC (HR 1.5, 95%CI: 0.8-2.7) or upper GIC risk (HR 1.0, 95%CI: 0.5-2.2). Patients with a positive FIT had only an increased risk of CRC-related death (HR 10.8, 95%CI: 2.1-57.1) and GIC-related death (HR 2.2, 95%CI: 1.1-4.3), with no differences in upper GIC-related death (HR 1.4, 95%CI: 0.6-3.3). An upper GIC was detected in 22 (0.8%) patients during the first year. Two variables were independently associated: anaemia (OR 5.6, 95%CI: 2.2-13.9) and age ≥ 70 years (OR 2.7, 95%CI: 1.1-7.0).
Symptomatic patients without CRC have a moderate risk increase in upper GIC, regardless of the FIT result. Patients with a positive FIT have an increased risk of post-colonoscopy CRC.
Guidelines recommend using prognostic scales for risk stratification in patients with non-variceal upper gastrointestinal bleeding. It remains unclear whether risk scores offer greater accuracy than ...clinical evaluation.
Compare the diagnostic accuracy of the endoscopist's judgment against different risk-scoring systems (Rockall, Glasgow-Blatchford, Baylor and the Cedars-Sinai scores) for predicting outcomes in peptic ulcer bleeding (PUB).
Between February 2006 and April 2010 we prospectively recruited 401 patients with peptic ulcer bleeding; 225 received endoscopic treatment. The endoscopist recorded his/her subjective assessment ("endoscopist judgment") of the risk of rebleeding and death immediately after endoscopy for each patient. Independent evaluators calculated the different scores. Area under the receiver-operating-characteristics (ROC) curve, sensitivity, specificity, positive and negative predictive values were calculated for rebleeding and mortality.
: The areas under ROC curve of the endoscopist's clinical judgment for rebleeding (0.67-0.75) and mortality (0.84-0.9) were similar or even superior to the different risk scores in both the whole group and in patients receiving endoscopic therapy.
The accuracy of the currently available risk scores for predicting rebleeding and mortality in PUB patients was moderate and not superior to the endoscopist's judgment. More precise prognostic scales are needed.
Abstract Background and study aims In colonoscopy, preparation is often regarded as the most burdensome part of the intervention. Traditionally, specific diets have been recommended, but the evidence ...to support this policy is insufficient. The aim of this study was to evaluate the impact of the decision not to follow a restrictive diet on bowel preparation and colonoscopy outcomes. Patients and methods This was a multicenter, controlled, non-inferiority randomized trial with FIT-positive screening colonoscopy. The subjects were assigned to follow the current standard (1-day low residue diet LRD) or a liberal diet. The allocation was balanced for the risk of inadequate cleansing using the Dik et al. score. All participants received the same instructions for morning colonoscopy preparation. The primary outcome was the rate of adequate preparations as defined by the Boston Bowel Preparation Scale. Secondary outcomes included tolerability and measures of colonoscopy performance and quality. Results A total of 582 subjects were randomized. Of these, 278 who received the liberal diet and 275 who received the 1-day LRD were included in the intent-to-treat analysis. Non-inferiority was demonstrated with adequate preparation rates of 97.8% in the 1-day LRD and 96.4% in the liberal diet group. Tolerability was higher with the liberal diet (94.7% vs. 83.2%). No differences were found with respect to cecal intubation time, aspirated volume, or length of the examination. Global and right colon average adenoma detection rates per colonoscopy were similar. Conclusions The liberal diet was non-inferior to the 1-day LRD, and increased tolerability. Colonoscopy performance and quality were not affected. (NCT05032794)
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