To develop personalized screening and surveillance strategies, the information required to superimpose state-specific covariates into the multi-step progression of disease natural history often ...relies on the entire population-based screening data, which are costly and infeasible particularly when a new biomarker is proposed. Following Prentice’s case-cohort concept, a non-standard case-cohort design from a previous study has been adapted for constructing multistate disease natural history with two-stage sampling. Nonetheless, the use of data only from first screens may invoke length-bias and fail to consider the test sensitivity. Therefore, a new sampling-based Markov regression model and its variants are proposed to accommodate additional subsequent follow-up data on various detection modes to construct state-specific covariate-based multistate disease natural history with accuracy and efficiency. Computer simulation algorithms for determining the required sample size and the sampling fraction of each detection mode were developed either through power function or the capacity of screening program. The former is illustrated with breast cancer screening data from which the effect size and the required sample size regarding the effect of BRCA on multistate outcome of breast cancer were estimated. The latter is applied to population-based colorectal cancer screening data to identify the optimal sampling fraction of each detection mode.
Background
Helicobacter pylori infection and metabolic syndrome have been reported to be positively associated. However, only a few studies have focused on this issue, and H. pylori serum antigen was ...used to diagnose infection in most of them. We aimed to investigate the association between metabolic syndrome factors and H. pylori infection, as diagnosed via a 13C‐urea breath test.
Materials and Methods
This cross‐sectional study consisted of 3578 subjects (18–64 years old) enrolled from one health management center between 2008 and 2013. H. pylori infection was defined as a positive urea breath test. The risk of metabolic syndrome from H. pylori infection was assessed using a multiple logistic regression model.
Results
The prevalence of the H. pylori was similar in both genders (20.6% in men and 19.7% in women). H. pylori ‐infected participants had significantly higher body mass index, fasting glucose, low‐density lipoprotein, and triglycerides, and lower high‐density lipoprotein (p < 0.05), than uninfected ones (p < 0.05). The prevalence of metabolic syndrome was higher in H. pylori ‐infected subjects than uninfected ones (men: 12.4% vs. 7.4%, p < 0.001; women: 7.4% vs. 2.5%, p < 0.001). Furthermore, H. pylori infection prevalence increased with metabolic score (P for trend <0.001, both sexes). Moreover, the association between metabolic syndrome and UBT positivity was significant in females (OR 1.91, 95% CI:1.03–3.53), but only borderline significant in males (OR 1.38, 95% CI: 0.97–1.95).
Conclusion
H. pylori infection is positively associated with metabolic syndrome, especially in females. The causal relationship between H. pylori infection and metabolic syndrome warrants further investigation.
Acute upper gastrointestinal bleeding (UGIB) in acute coronary syndrome (ACS) patients are not uncommon, particularly under dual antiplatelet therapy (DAPT). The efficiency and safety of early ...endoscopy (EE) for UGIB in these patients needs to be elucidated. This multicenter randomized controlled trial randomized recent ACS patients presenting acute UGIB to non-EE and EE groups. All eligible patients received intravenous proton pump inhibitor therapy. Those in EE group underwent therapeutic endoscopy within 24 h after bleeding. The data regarding efficacy and safety of EE were analyzed. It was early terminated because the UGIB rate was lower than expected and interim analysis was done. In total, 43 patients were randomized to non-EE (21 patients) and EE (22 patients) groups. The failure rate of control hemorrhage (intention-to-treat ITT 4.55% vs. 23.81%, p < 0.001; per-protocol PP 0% vs. 4.55%, p = 0.058) and 3-day rebleeding rate (ITT 4.55% vs. 28.57%, p = 0.033; PP 0% vs. 21.05%, p = 0.027) were lower in EE than non-EE group. The mortality, minor and major complication rates were not different between two groups. Male patients were at higher risk of minor and major complications after EE with OR (95% CI) of 3.50 (1.15-10.63) and 4.25 (1.43-12.63), respectively. In multivariate analysis, EE was associated with lower needs for blood transfusion (HR 0.13, 95% CI 0.02-0.98). Among patients who discontinued DAPT during acute UGIB, a higher risk (OR 5.25, 95% CI 1.21-22.74) of coronary artery stent re-thrombosis within 6 months was noticed. EE for acute UGIB in recent ACS patients has higher rate of bleeding control, lower 3-day rebleeding rate and lower needs for blood transfusion, but more complications in male patients. Further enrollment is mandatory to avoid bias from small sample size (ClinicalTrial.gov Number NCT02618980, registration date 02/12/2015).
Non-invasive screening for colorectal cancer in Asia Chiu, Han-Mo, M.D., PhD; Chang, Li-Chun, M.D., MSc; Hsu, Wen-Feng, M.D., MSc ...
Baillière's best practice & research. Clinical gastroenterology,
12/2015, Volume:
29, Issue:
6
Journal Article
Peer reviewed
Abstract There is an increasing trend of colorectal cancer incidence in Asia and nearly 45% of CRC cases worldwide occur in Asia therefore screening for CRC becomes an urgent task. Stool-based tests, ...including guaiac fecal occult blood test (gFOBT) and fecal immunochemical test (FIT), can select subjects at risk of significant colorectal neoplasms from the large target population thus are currently the most commonly used non-invasive screening tool in large population screening programs. FIT has the advantage over gFOBT in terms of higher sensitivity for early neoplasms, the ability to provide high-throughput automatic analysis, and better public acceptance thus greater effectiveness on reducing CRC mortality and incidence is expected. Owing to the large target population and constrained endoscopic capacity and manpower, FIT is nowadays the most popular CRC screening test in Asia. Some Asian countries have launched nationwide screening program in the past one or two decades but also encountered some challenges such as low screening participation rate, low verification rate after positive stool tests, low public awareness, and insufficient manpower. In addition, some controversial or potential future research issues are also addressed in this review.
In patients with positive results from a fecal immunochemical test (FIT), failure to receive a timely follow-up colonoscopy may be associated with higher risks of colorectal cancer (CRC) and ...advanced-stage CRC. We evaluated the prevalence of any CRC and advanced-stage CRC associated with delays in follow-up colonoscopies for patients with positive results from a FIT.
We collected data from 39,346 patients (age, 50–69 years) who participated in the Taiwanese Nationwide Screening Program from 2004 through 2012 and had completed a colonoscopy more than 1 month after a positive result from a FIT. Risks of any CRC and advanced-stage CRC (stage III-IV) were evaluated using logistic regression models and results expressed as adjusted odds ratios (aORs) and corresponding 95% CIs.
In our cohort, 2003 patients received a diagnosis of any CRC and 445 patients were found to have advanced-stage disease. Compared with colonoscopy within 1–3 months (cases per 1000 patients: 50 for any CRC and 11 for advanced-stage disease), risks were significantly higher when colonoscopy was delayed by more than 6 months for any CRC (aOR, 1.31; 95% CI, 1.04–1.64; 68 cases per 1000 patients) and advanced-stage disease (aOR, 2.09; 95% CI, 1.43–3.06; 24 cases per 1000 patients). The risks continuously increased when colonoscopy was delayed by more than 12 months for any CRC (aOR, 2.17; 95% CI, 1.44–3.26; 98 cases per 1000 patients) and advanced-stage disease (aOR, 2.84; 95% CI, 1.43–5.64; 31 cases per 1000 patients). There were no significant differences for colonoscopy follow up at 3–6 months for risk of any CRC (aOR, 0.98; 95% CI, 0.86–1.12; 49 cases per 1000 patients) or advanced-stage disease (aOR, 0.95; 95% CI, 0.72–1.25; 10 cases per 1000 patients).
In an analysis of data from the Taiwanese Nationwide Screening Program, we found that among patients with positive results from a FIT, risks of CRC and advanced-stage disease increase with time. These findings indicate the importance of timely colonoscopy after a positive result from a FIT.
Background and Aim
Risk factors for acute variceal bleeding in patients with hepatocellular carcinoma (HCC) and concurrent main portal vein thrombosis (PVT) remain unclear. We aimed to determine risk ...factors of in‐hospital mortality after acute variceal bleeding for HCC patients with concurrent main PVT.
Methods
We conducted a retrospective analysis of 102 HCC patients (83% men and 17% women) with concurrent main PVT and acute variceal bleeding. All patients received emergent endoscopy to define the bleeding source. Multivariable Cox proportional hazard regression analysis consisting of clinical, laboratory, and endoscopic parameters was performed to identify predictive factors for intrahospital mortality.
Results
Twenty‐eight (27.5%) patients died within admission. The median survival of all patients was 56 days. Multivariable Cox proportional hazard regression analyses revealed Child‐Pugh score (adjusted hazard ratio aHR: 1.29 for each point; 95% confidence interval CI: 1.11–1.50), active bleeding on index endoscopy (aHR: 7.50; 95% CI: 3.05–18.4), esophageal varices as the bleeder (compared with gastric varices, aHR: 14.3; 95% CI: 3.12–66.1), failure to control bleeding (aHR: 38.0; 95% CI: 7.44–194), and serum creatinine (aHR: 1.28 for each increase of 1 mg/dL; 95% CI: 1.09–1.50) independently predicted in‐hospital mortality.
Conclusions
Hepatic reserve, active bleeding on index endoscopy, failure to control bleeding, esophageal varices as the bleeder when compared with gastric varices, and renal function were independent predictive factors for in‐hospital mortality in HCC patients with acute variceal bleeding and concurrent main PVT.
Background:
Whether adjunctive N-acetylcysteine (NAC) may improve the efficacy of triple therapy in the first-line treatment of Helicobacter pylori infection remains unknown. Our aim was to compare ...the efficacy of 14-day triple therapy with or without NAC for the first-line treatment of H. pylori.
Material and methods:
Between 1 January 2014 and 30 June 2018, 680 patients with H. pylori infection naïve to treatment were enrolled in this multicenter, open-label, randomized trial. Patients were randomly assigned to receive triple therapy with NAC NAC-T14, dexlansoprazole 60 mg four times daily (q.d.); amoxicillin 1 g twice daily (b.i.d.), clarithromycin 500 mg b.i.d., NAC 600 mg b.i.d. for 14 days, or triple therapy alone (T14, dexlansoprazole 60 mg q.d.; amoxicillin 1 g b.i.d., clarithromycin 500 mg b.i.d.) for 14 days. Our primary outcome was the eradication rates by intention to treat (ITT). Antibiotic resistance and CYP2C19 gene polymorphism were determined.
Results:
The ITT analysis demonstrated H. pylori eradication rates in NAC-T14 and T14 were 81.7% 276/338, 95% confidence interval (CI): 77.5–85.8% and 84.3% (285/338, 95% CI 80.4–88.2%), respectively. In 646 participants who adhered to their assigned therapy, the eradication rates were 85.7% and 88.0% with NAC-T14 and T14 therapies, respectively. There were no differences in compliance or adverse effects. The eradication rates in subjects with clarithromycin-resistant, amoxicillin-resistant, or either clarithromycin/amoxicillin resistant strains were 45.2%, 57.9%, and 52.2%, respectively, for NAC-T14, and were 66.7%, 76.9%, and 70.0%, respectively, for T14. The efficacy of NAC-T14 and T14 was not affected by CYP2C19 polymorphism.
Conclusion:
Add-on NAC to triple therapy was not superior to triple therapy alone for first-line H. pylori eradication ClinicalTrials.gov identifier: NCT02249546.
Carbon dioxide (CO2) insufflation during colonoscopy can significantly decrease abdominal pain and bloating after the procedure, but its impact on the frequency and duration of toilet use remains ...unknown. The aim of this study was to assess the impact of CO2 insufflation on toilet use after screening colonoscopy.
From 138 average-risk individuals who underwent screening colonoscopy during March to August 2013, 120 were enrolled and randomized to receive either CO2 or air insufflation at colonoscopy. Both the colonoscopist and participant were blinded to the type of gas used. Abdominal pain and distension were assessed using a visual analog scoring system. The frequency and duration of toilet visits during a 2-hour postcolonoscopy period were recorded using a radiofrequency identification system.
Baseline characteristics were similar in both groups in terms of age, sex, and procedure time. In the 2 hours after colonoscopy, 50 participants (83 %) in the air group and 18 participants (30 %) in the CO2 group (P < 0.001) used the toilet at least once. The mean (± SD) duration of each toilet visit was 5.93 ± 4.65 minutes in the air group and 1.53 ± 2.84 minutes in the CO2 group (P < 0.001). The abdominal discomfort score was lower in the CO2 group than in the air group both at the end of the colonoscopy (P < 0.001) and 2 hours later (P < 0.001).
Insufflation with CO2 can significantly reduce abdominal discomfort and toilet use after colonoscopy. Use of this technique may help reduce patient burden and allow more efficient use of space in the endoscopy unit.
Although cold snare polypectomy (CSP) is considered effective in reducing delayed postpolypectomy bleeding risk, direct evidence supporting its safety in the general population remains lacking.
To ...clarify whether CSP would reduce delayed bleeding risk after polypectomy compared with hot snare polypectomy (HSP) in the general population.
Multicenter randomized controlled study. (ClinicalTrials.gov: NCT03373136).
6 sites in Taiwan, July 2018 through July 2020.
Participants aged 40 years or older with polyps of 4 to 10 mm.
CSP or HSP to remove polyps of 4 to 10 mm.
The primary outcome was the delayed bleeding rate within 14 days after polypectomy. Severe bleeding was defined as a decrease in hemoglobin concentration of 20 g/L or more, requiring transfusion or hemostasis. Secondary outcomes included mean polypectomy time, successful tissue retrieval, en bloc resection, complete histologic resection, and emergency service visits.
A total of 4270 participants were randomly assigned (2137 to CSP and 2133 to HSP). Eight patients (0.4%) in the CSP group and 31 (1.5%) in the HSP group had delayed bleeding (risk difference, -1.1% 95% CI, -1.7% to -0.5%). Severe delayed bleeding was also lower in the CSP group (1 0.05% vs. 8 0.4% events; risk difference, -0.3% CI, -0.6% to -0.05%). Mean polypectomy time (119.0 vs. 162.9 seconds; difference in mean, -44.0 seconds CI, -53.1 to -34.9 seconds) was shorter in the CSP group, although successful tissue retrieval, en bloc resection, and complete histologic resection did not differ. The CSP group had fewer emergency service visits than the HSP group (4 0.2% vs. 13 0.6% visits; risk difference, -0.4% CI, -0.8% to -0.04%).
An open-label, single-blind trial.
Compared with HSP, CSP for small colorectal polyps significantly reduces the risk for delayed postpolypectomy bleeding, including severe events.
Boston Scientific Corporation.
We aimed to compare the efficacy of genotypic resistance–guided therapy vs empirical therapy for eradication of refractory Helicobacter pylori infection in randomized controlled trials.
We performed ...2 multicenter, open-label trials of patients with H pylori infection (20 years or older) failed by 2 or more previous treatment regimens, from October 2012 through September 2017 in Taiwan. The patients were randomly assigned to groups given genotypic resistance–guided therapy for 14 days (n = 21 in trial 1, n = 205 in trial 2) or empirical therapy according to medication history for 14 days (n = 20 in trial 1, n = 205 in trial 2). Patients received sequential therapy containing esomeprazole and amoxicillin for the first 7 days, followed by esomeprazole and metronidazole, with levofloxacin, clarithromycin, or tetracycline (doxycycline in trial 1, tetracycline in trial 2) for another 7 days (all given twice daily) based on genotype markers of resistance determined from gastric biopsy specimens (group A) or empirical therapy according to medication history. Resistance-associated mutations in 23S ribosomal RNA or gyrase A were identified by polymerase chain reaction with direct sequencing. Eradication status was determined by 13C-urea breath test. The primary outcome was eradication rate.
H pylori infection was eradicated in 17 of 21 (81%) patients receiving genotype resistance–guided therapy and 12 of 20 (60%) patients receiving empirical therapy (P = .181) in trial 1. This trial was terminated ahead of schedule due to the low rate of eradication in patients given doxycycline sequential therapy (15 of 26 57.7%). In trial 2, H pylori infection was eradicated in 160 of 205 (78%) patients receiving genotype resistance–guided therapy and 148 of 205 (72.2%) patients receiving empirical therapy (P = .170), according to intent to treat analysis. The frequencies of adverse effects and compliance did not differ significantly between groups.
Properly designed empirical therapy, based on medication history, is an acceptable alternative to genotypic resistance–guided therapy for eradication of refractory H pylori infection after consideration of accessibility, cost, and patient preference. ClinicalTrials.gov ID: NCT01725906.
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