Summary Background Present guidelines are conflicting for patients at high risk of both cardiovascular and gastrointestinal events who continue to require non-steroidal anti-inflammatory drugs ...(NSAIDs). We hypothesised that a cyclooxygenase-2-selective NSAID plus proton-pump inhibitor is superior to a non-selective NSAID plus proton-pump inhibitor for prevention of recurrent ulcer bleeding in concomitant users of aspirin with previous ulcer bleeding. Methods For this industry-independent, double-blind, double-dummy, randomised trial done in one academic hospital in Hong Kong, we screened patients with arthritis and cardiothrombotic diseases who were presenting with upper gastrointestinal bleeding, were on NSAIDs, and require concomitant aspirin. After ulcer healing, an independent staff member randomly assigned (1:1) patients who were negative for Helicobacter pylori with a computer-generated list of random numbers to receive oral administrations of either celecoxib 100 mg twice per day plus esomeprazole 20 mg once per day or naproxen 500 mg twice per day plus esomeprazole 20 mg once per day for 18 months. All patients resumed aspirin 80 mg once per day. Both patients and investigators were masked to their treatments. The primary endpoint was recurrent upper gastrointestinal bleeding within 18 months. The primary endpoint and secondary safety endpoints were analysed in the modified intention-to-treat population. This study was registered with ClinicalTrials.gov , number NCT00153660. Findings Between May 24, 2005, and Nov 28, 2012, we enrolled 514 patients, assigning 257 patients to each study group, all of whom were included in the intention-to-treat population. Recurrent upper gastrointestinal bleeding occurred in 14 patients in the celecoxib group (nine gastric ulcers and five duodenal ulcers) and 31 patients in the naproxen group (25 gastric ulcers, three duodenal ulcers, one gastric ulcer and duodenal ulcer, and two bleeding erosions). The cumulative incidence of recurrent bleeding in 18 months was 5·6% (95% CI 3·3–9·2) in the celecoxib group and 12·3% (8·8–17·1) in the naproxen group (p=0·008; crude hazard ratio 0·44, 95% CI 0·23–0·82; p=0·010). Excluding patients who reached study endpoints, 21 (8%) patients in the celecoxib group and 17 (7%) patients in the naproxen group had adverse events leading to discontinuation of treatment. No treatment-related deaths occurred during the study. Interpretation In patients at high risk of both cardiovascular and gastrointestinal events who require concomitant aspirin and NSAID, celecoxib plus proton-pump inhibitor is the preferred treatment to reduce the risk of recurrent upper gastrointestinal bleeding. Naproxen should be avoided despite its perceived cardiovascular safety. Funding The Research Grant Council of Hong Kong.
Background The need for therapeutic endoscopy in patients with upper GI hemorrhage is important in determining the risk and disposition of these patients. Pre-endoscopic risk scores may be helpful in ...predicting this need. Objective To test the Blatchford and pre-endoscopic Rockall scores with the need for therapeutic endoscopy as the primary outcome. Design Prospective validation study. Setting Tertiary-care university-affiliated hospital. Patients and Interventions Between January 1, 2006 and February 28, 2007, 1087 patients with upper GI hemorrhage who had undergone an inpatient EGD within 24 hours were entered in the study. Main Outcome Measurements Blatchford and pre-endoscopic Rockall scores were prospectively calculated for all patients, and the need for therapeutic endoscopy was determined during the EGD. Results Of the 1087 patients, 297 (27.3%) needed therapeutic endoscopy. The mean Blatchford score for those who needed therapeutic endoscopy was significantly higher (mean standard deviation: 10.3 3.5 vs 7.0 4.4, P < .001). The area under a receiver-operating characteristic curve was 0.72 (95% CI, 0.68-0.75). A threshold of 0 (low risk) predicted the need for therapeutic endoscopy with 100% sensitivity and 6.3% specificity. Fifty (4.6%) patients were identified as low risk. The pre-endoscopic Rockall score was unable to predict this need. Limitations The decision to perform therapeutic endoscopy is a subjective one, although endoscopists are trained to follow international consensus guidelines. Conclusions The Blatchford score is more useful for predicting low-risk patients who do not need therapeutic endoscopy and who may be suitable for outpatient management. A threshold of 0 for low risk should be used. The Rockall score is not helpful in predicting the presence of low-risk lesions.
Background and Aims Upper GI bleeding (UGIB) still constitutes one of the major hospital admissions through emergency departments (EDs). This feasibility study aims to test whether capsule endoscopy ...(CE) can reduce unnecessary hospital admissions in patients with suspected UGIB. Methods This was a prospective randomized controlled trial in which patients who presented with symptoms or signs suggestive of UGIB were randomized to receive either the standard treatment (ST) of hospital management or receive CE, after which hospital admission was determined by the findings of CE. Patients were also graded by Glasgow Blatchford score (GBS) at the ED for assessment of need of hospital admission. Results Seventy-one patients fulfilled the recruitment criteria, with 37 subjects enrolled into the CE group and 34 subjects into the ST group. Seven CE patients with active bleeding or significant endoscopic findings were admitted to the hospital compared with the ST group in which all 34 patients were admitted. There was no difference in the clinical outcome in terms of recurrent bleeding and 30-day mortality. Hospital admission was also greatly reduced if CE instead of GBS was used to triage patients in the ED. Conclusions This feasibility study shows that CE offers a safe and effective method in triaging patients presenting with symptoms of UGIB that do not require hospital admission. (Clinical trial registration number: NCT02446678 .)
Background The Asia-Pacific Colorectal Screening (APCS) score based on age, gender, family history, and smoking is useful to predict advanced colorectal neoplasia (ACN) in asymptomatic Asian ...subjects. Purpose To evaluate the factors in addition to those of APCS associated with ACN colonoscopic findings. Methods Data from 5,220 asymptomatic subjects aged between 50 and 70 years who underwent screening colonoscopy in a community center between 2008 and 2012 were analyzed. One binary logistic regression analysis was conducted in 2013 with the presence of ACN or cancer as the outcome, controlling for APCS score, alcohol consumption, BMI, hypertension, and other chronic diseases as independent variables. Results The average participant age was 57.7 years (SD=4.9) and 47.5% were men. Advanced neoplasms or cancers were identified at colonoscopy in 5.6% of all screening participants. From multivariate regression analysis, APCS score≥4 (adjusted OR AOR=1.74, 95% CI=1.34, 2.25, p <0.001); overweight (BMI=23−24.9, AOR=1.52, 95% CI=1.12, 2.07, p =0.007); obesity (BMI≥25, AOR=1.56, 95% CI=1.15, 2.10, p =0.004); hypertension (AOR=1.58, 95% CI=1.21, 2.06, p =0.001); and alcohol consumption (AOR=1.47, 95% CI=1.05, 2.06, p =0.025) were associated with ACN. The c-statistic of APCS score alone was 0.560 (95% CI=0.524, 0.595, p =0.001) and that of APCS score plus BMI, hypertension, and alcohol consumption was 0.613 (95% CI=0.578, 0.648, p <0.001). Conclusions Alcohol consumption, hypertension, and BMI are independent predictors of ACN, which could be incorporated into the APCS for prioritizing Asian asymptomatic subjects for colorectal cancer screening.
Background Certain subgroups have higher rates of false fecal immunochemical test (FIT) results, yet few studies have addressed this topic. Objective To identify demographic factors associated with ...false-positive and false-negative FIT results in colorectal cancer screening. Design Retrospective database review of prospectively collected data. Setting A bowel cancer screening center in Hong Kong invited participants for colorectal cancer screening (2008-2012). Patients Study participants who underwent both FIT and colonoscopy in the first year (n = 4482) and underwent colonoscopy after negative FIT results for 3 consecutive years (n = 857). Main Outcome Measurements The diagnostic accuracy and predictive values of FIT according to participant characteristics. Results The sensitivity, specificity, positive predictive values, and negative predictive values for advanced neoplasia were 33.1%, 91.9%, 19.0%, and 96.0%, respectively. Participants 66 to 70 years of age had higher sensitivity, whereas older age, smoking, and use of aspirin/nonsteroidal anti-inflammatory drugs were associated with lower specificity. The rates of false-positive and false-negative results were 8.1% and 66.9%, respectively. Older age (66-70 years; adjusted odds ratio AOR 1.95; 95% confidence interval CI, 1.35-2.81; P < .001), smoking (AOR 1.68; 95% CI, 1.08-2.61; P = .020), and the presence of polypoid adenoma (AOR 1.71; 95% CI, 1.14-2.57; P = .009) were associated with false-positive results. Younger participants (AOR for elderly participants 0.31) and the use of aspirin/nonsteroidal anti-inflammatory drugs (AOR 4.44) in participants with 1 FIT with negative results and the absence of high-grade dysplasia (AOR for presence 0.41) were associated with false-negative results. Limitations Self-referred participants who received one type of qualitative FIT. Conclusion These findings could be used to target screening more toward those with a higher risk of false-negative results and those with a lower risk of false-positive results for earlier colonoscopy.
Summary Background Guidelines on pain management recommend that patients at risk of ulcers receive either a cyclo-oxygenase (COX 2) inhibitor or a non-steroidal anti-inflammatory drug (NSAID) with a ...proton-pump inhibitor (PPI). These two treatments have similar effectiveness, but they are insufficient for protection of patients at very high risk for ulcer bleeding. We aimed to test the hypothesis that in patients with previous ulcer bleeding induced by non-selective NSAIDs, combined treatment with the COX 2 inhibitor celecoxib and the PPI esomeprazole would be better than celecoxib alone for prevention of recurrent ulcer bleeding. Methods 441 consecutively presenting patients who were taking non-selective NSAIDs for arthritis were recruited to our single-centre, prospective, randomised, double-blind trial after admission to hospital with upper-gastrointestinal bleeding. Patients were enrolled after their ulcers had healed and a histological test for Helicobacter pylori was negative. All patients were given 200 mg celecoxib twice daily. 137 patients were randomly assigned to receive 20 mg esomeprazole twice daily (combined-treatment group), and 136 to receive a placebo (control group) for 12 months. The primary endpoint was recurrent ulcer bleeding during treatment or within 1 month of the end of treatment. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov , number NCT00365313. Findings Combination treatment was more effective than celecoxib alone for prevention of ulcer bleeding in patients at high risk. The 13-month cumulative incidence of the primary endpoint was 0% in the combined-treatment group and 12 (8·9%) in the controls (95% CI difference, 4·1 to 13·7; p=0·0004). The median follow-up was 13 months (range 0·4–13·0). Discontinuation of treatment and the incidence of adverse events were similar in the two treatment groups. Interpretation Patients at very high risk for recurrent ulcer bleeding who need anti-inflammatory analgesics should receive combination treatment with a COX 2 inhibitor and a PPI. Our findings should encourage guideline committees to review their recommendations for patients at very high risk of recurrent ulcer bleeding.
Background and Aims Current evidence of whether distal hyperplastic polyps (HPs) are markers of proximal neoplasia (PN) is mixed. We evaluated the association between distal neoplasia and synchronous ...PN in asymptomatic subjects. Methods We recruited 5819 Chinese asymptomatic screening participants 50 to 70 years of age who underwent colonoscopy in Hong Kong from 2008 to 2014, of whom 206 subjects with distal advanced neoplasia or cancer were excluded. The association between distal pathology (tubular adenomas TAs, HPs, no polyps) and proximal pathology (PN, proximal advanced neoplasia PAN) was assessed by multivariate regression models, overall and stratified by the Asia Pacific Colorectal Screening scoring system (scores of 4-7, high risk; scores of 0-3, lower risk). Results The prevalence of PN in the no distal polyps group, distal HPs group, and distal TAs group was 14.8%, 19.3%, and 29.4%, respectively. The corresponding prevalence of PAN was 1.8%, 3.2%, and 3.5%. Participants with distal HPs did not have significantly higher odds of PN (adjusted odds ratio AOR 1.24; 95% confidence interval CI, 0.97-1.59; P = .089), and their association with PAN was marginally significant (AOR 1.77; 95% CI, 1.00-3.13; P = .052), except in lower risk subjects for whom the odds of PAN were marginally higher in the distal HPs group than the no distal polyps group (AOR 1.97; 95% CI, 1.01-3.85; P = .048). Overall, the distal polyps group had significantly lower odds of PN than the distal TAs group (AOR 0.55; 95% CI, 0.40-0.76; P < .001). The increased risk of PN and PAN among those with distal HPs was modest. Conclusions A direct association between distal HPs and PN is lacking, and this implies a need for a multivariate assessment of the risk of PAN. Recommending colonoscopy for every patient with distal HPs detected by screening sigmoidoscopy is not supported by this study.
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