Bleeding Risk of Cold Versus Hot Snare Polypectomy for Pedunculated Colorectal Polyps Measuring 10 mm or Less: Subgroup Analysis of a Large Randomized Controlled Trial.

INTRODUCTION: Concerns regarding bleeding remain in cold snare polypectomy (CSP) for small pedunculated (0-Ip) polyps. The aim of this study was to compare the risk of CSP and hot snare polypectomy (HSP) for such lesions. METHODS: Data on 0-Ip colorectal polyps ≤10 mm were extracted from a large, pragmatic, randomized trial. Immediate postpolypectomy bleeding (IPPB), defined as the perioperative use of a clip for bleeding, was evaluated through polyp-level analysis. Delayed postpolypectomy bleeding (DPPB), defined as bleeding occurring within 2 weeks postoperatively, was assessed at the patient-level among patients whose polyps were all ≤10 mm, including at least one 0-Ip polyp. RESULTS: A total of 647 0-Ip polyps (CSP: 306; HSP: 341) were included for IPPB analysis and 386 patients (CSP: 192; HSP: 194) for DPPB analysis. CSP was associated with a higher incidence of IPPB (10.8% vs 3.2%, P < 0.001) but no adverse clinical events. The procedure time of all polypectomies was shorter for CSP than for HSP (123.0 ± 117.8 vs 166.0 ± 237.7 seconds, P = 0.003), while the procedure time of polypectomies with IPPB were similar (249.8 ± 140.2 vs 227.4 ± 125.9 seconds, P = 0.64). DPPB was observed in 3 patients (1.5%) in the HSP group, including one patient (0.5%) with severe bleeding, but not in the CSP group. DISCUSSION: Despite CSP being associated with more IPPB events, it could be timely treated without adverse outcomes. Notably, no delayed bleeding occurred in the CSP group. Our findings support the use of CSP for 0-Ip polyps ≤ 10 mm.

The impact of comorbidities, neutrophil-to-lymphocyte ratio, and drug toxicities on quality of life in lung cancer patients receiving EGFR-TKI therapy.

BACKGROUND: Epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) are used as the standard first-line treatment for patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC). However, the impact of comorbidities and treatment toxicities on quality of life (QoL) was seldom investigated. OBJECTIVE: We aimed to investigate the association of comorbidities, adverse events (AEs), and QoL in treatment-naïve advanced NSCLC patients receiving EGFR-TKI treatments. METHODS: This multi-center prospective observational study was conducted to evaluate QoL and AEs at baseline, the 2nd, 4th, 12th, and 24th week. Clinical characteristics, comorbidities, and pre-treatment laboratory data were recorded. QoL was assessed by using the summary score of the EORTC QLQ-C30 and the dermatology life quality index. The impact of comorbidities, neutrophil-to-lymphocyte ratio (NLR), and AEs on QoL was analyzed by generalized estimating equations. RESULTS: A total of 121 patients were enrolled. Diarrhea (p = 0.033), anorexia (p < 0.001), and NLR ≥4 (p = 0.017) were significantly associated with a QoL impairment. Among skin toxicities, acneiform rash (p = 0.002), pruritus (p = 0.002), visual analogue scale for pruritus (≥3 and < 7, p = 0.006; ≥7, p = 0.001) and pain (1-3, p = 0.041) were associated with a QoL impairment. No significant association was found between comorbidities and QoL changes. CONCLUSION: Diarrhea, anorexia, skin pain, and pruritus may cause a deterioration in QoL in patients receiving EGFR-TKI therapy. NLR may be a potential predictive factor for QoL impairment. Aggressive management and close monitoring for these clinical factors are crucial to improve QoL.

Cold Versus Hot Snare Polypectomy for Small Colorectal Polyps : A Pragmatic Randomized Controlled Trial.

BACKGROUND: 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. OBJECTIVE: To clarify whether CSP would reduce delayed bleeding risk after polypectomy compared with hot snare polypectomy (HSP) in the general population. DESIGN: Multicenter randomized controlled study. (ClinicalTrials.gov: NCT03373136). SETTING: 6 sites in Taiwan, July 2018 through July 2020. PARTICIPANTS: Participants aged 40 years or older with polyps of 4 to 10 mm. INTERVENTION: CSP or HSP to remove polyps of 4 to 10 mm. MEASUREMENTS: 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. RESULTS: 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%]). LIMITATION: An open-label, single-blind trial. CONCLUSION: Compared with HSP, CSP for small colorectal polyps significantly reduces the risk for delayed postpolypectomy bleeding, including severe events. PRIMARY FUNDING SOURCE: Boston Scientific Corporation.

Real-World Evidence of Effectiveness and Safety of Vedolizumab for Inflammatory Bowel Disease in Taiwan: A Prospective Nationwide Registry (VIOLET) Study.

BACKGROUND: This nationwide prospective registry study investigated the real-world effectiveness, safety, and persistence of vedolizumab (VDZ) in inflammatory bowel disease (IBD) patients in Taiwan. Disease relapse rates after VDZ discontinuation due to reimbursement restriction were assessed. METHODS: Data were collected prospectively (January 2018 to May 2020) from the Taiwan Society of IBD registry. RESULTS: Overall, 274 patients (147 ulcerative colitis [UC] patients, 127 Crohn's disease [CD] patients) were included. Among them, 70.7% with UC and 50.4% with CD were biologic-naïve. At 1 year, 76.0%, 58.0%, 35.0%, and 62.2% of UC patients and 57.1%, 71.4%, 33.3%, and 30.0% of CD patients achieved clinical response, clinical remission, steroid-free remission, and mucosal healing, respectively. All patients underwent hepatitis B and tuberculosis screening before initiating biologics, and prophylaxis was recommended when necessary. One hepatitis B carrier, without antiviral prophylaxis due to economic barriers, had hepatitis B reactivation during steroid tapering and increasing azathioprine dosage, which was controlled with an antiviral agent. No tuberculosis reactivation was noted. At 12 months, non-reimbursement-related treatment persistence rates were 94.0% and 82.5% in UC and CD patients, respectively. Moreover, 75.3% of IBD patients discontinued VDZ due to mandatory drug holiday. Relapse rates after VDZ discontinuation at 6 and 12 months were 36.7% and 64.3% in CD patients and 42.9% and 52.4% in UC patients, respectively. CONCLUSIONS: The findings demonstrated VDZ effectiveness in IBD patients in Taiwan, with high treatment persistence rates and favorable safety profiles. A substantial IBD relapse rate was observed in patients who had mandatory drug holiday.

Implementing precision medicine in endoscopy practice.

In contrast to the "one-size-fits-all" approach, precision medicine focuses on providing health care tailored to individual variabilities. Implementing precision medicine in endoscopy practice involves selecting the appropriate procedures among the endoscopic armamentarium in the diagnosis and management of patients in a logical sequence, jointly considering the pretest probabilities of possible diagnoses, patients' comorbidities and preference, and risk-benefit ratio of the individual procedures given the clinical scenario. The aim of this review is to summarize evidence-supported strategies and measures that may enhance precision medicine in general endoscopy practice.

5-HT7 receptor-dependent intestinal neurite outgrowth contributes to visceral hypersensitivity in irritable bowel syndrome.

Irritable bowel syndrome (IBS) is characterized by visceral hypersensitivity (VH) associated with abnormal serotonin/5-hydroxytryptamine (5-HT) metabolism and neurotrophin-dependent mucosal neurite outgrowth. The underlying mechanisms of VH remain poorly understood. We investigated the role of 5-HT7 receptor in mucosal innervation and intestinal hyperalgesia. A high density of mucosal nerve fibres stained for 5-HT7 was observed in colonoscopic biopsy specimens from IBS patients compared with those from healthy controls. Staining of 5-HT3 and 5-HT4 receptors was observed mainly in colonic epithelia with comparable levels between IBS and controls. Visceromotor responses to colorectal distension were evaluated in two mouse models, one postinfectious with Giardia and subjected to water avoidance stress (GW) and the other postinflammatory with trinitrobenzene sulfonic acid-induced colitis (PT). Increased VH was associated with higher mucosal density of 5-HT7-expressing nerve fibres and elevated neurotrophin and neurotrophin receptor levels in the GW and PT mice. The increased VH was inhibited by intraperitoneal injection of SB-269970 (a selective 5-HT7 antagonist). Peroral multiple doses of CYY1005 (a novel 5-HT7 ligand) decreased VH and reduced mucosal density of 5-HT7-expressing nerve fibres in mouse colon. Human neuroblastoma SH-SY5Y cells incubated with bacteria-free mouse colonic supernatant, 5-HT, nerve growth factor, or brain-derived neurotrophic factor exhibited nerve fibre elongation, which was inhibited by 5-HT7 antagonists. Gene silencing of HTR7 also reduced the nerve fibre length. Activation of 5-HT7 upregulated NGF and BDNF gene expression, while stimulation with neurotrophins increased the levels of tryptophan hydroxylase 2 and 5-HT7 in neurons. A positive-feedback loop was observed between serotonin and neurotrophin pathways via 5-HT7 activation to aggravate fibre elongation, whereby 5-HT3 and 5-HT4 had no roles. In conclusion, 5-HT7-dependent mucosal neurite outgrowth contributed to VH. A novel 5-HT7 antagonist could be used as peroral analgesics for IBS-related pain.

Association of Incidence of Acid-related Upper Gastrointestinal Disorders With Glycated Hemoglobin Level.

CONTEXT: Previous cross-sectional studies show diabetes and higher levels of plasma hemoglobin A1c (HbA1c) are associated with a higher prevalence of gastrointestinal (GI) complications. However, whether the glycemic status is associated with incident acid-related upper GI disorders remains unclear. OBJECTIVE: We aimed to determine the effect of hyperglycemia per se, in terms of HbA1c, on the incidence of acid-related disorders. METHODS: We analyzed consecutive subjects who had undergone repeated upper endoscopies as part of the health examinations at the National Taiwan University Hospital from 2005 to 2011. Acid-related endoscopic abnormalities were defined as erosive esophagitis (EE), Barrett's esophagus (BE), and peptic ulcer disease (PUD), which included gastric ulcers (GUs) and duodenal ulcers (DUs). All subjects were categorized by 3 tertiles of HbA1c levels. We analyzed the occurrence of respective acid-related disorders during the follow-up period. RESULTS: A total of 11 391 participants (mean HbA1c level 5.6 ±â€…0.7%) were enrolled in this longitudinal study. During the 38 426.3 person-years of follow-up (mean duration 3.37 ±â€…1.59 years), the incidence of EE, BE, GU, DU, PUD, and any acid-related disorders were 22.1%, 0.5%, 4.5%, 8.6%, 12.3%, and 30.3%, respectively. The higher HbA1c level was associated with higher risk of disease incidents, except BE, during the follow-up (all log-rank P < .001). In the Cox regression analyses with confounding factors fully adjusted, the hazard ratios for EE, GU, DU, PUD, and acid-related disorders were 1.174, 1.339, 1.24, 1.24, and 1.186, respectively, for the third tertile of HbA1c (all P < .05). CONCLUSION: Higher HbA1c level was associated with a higher risk of acid-related upper GI endoscopic abnormalities. Efforts toward better glycemic control may help to prevent the development of late GI complications.

Obesity Exacerbates Irritable Bowel Syndrome-Related Sleep and Psychiatric Disorders in Women With Polycystic Ovary Syndrome.

Background/Objectives: Polycystic ovary syndrome (PCOS) and irritable bowel syndrome (IBS) share similar clinical and psychosocial features. We aimed to investigate the clinical characteristics of IBS in women with PCOS, and its relationship with obesity, metabolic and hormonal profiles, as well as sleep and psychiatric disorders. Subjects/Methods: This is a cross-sectional case-control study of 431 untreated women with PCOS and 259 healthy volunteers. All participants were assessed with a comprehensive clinical evaluation and two questionnaires: the Athens Insomnia Scale (AIS) and the Brief Symptom Rating Scale (BSRS-5). IBS was diagnosed using the Rome III criteria. Obesity was defined as a BMI ≥30 kg/m2. Anthropometric measurements, metabolic, hormonal profiles, and psychosocial morbidities were compared. Results: Women with PCOS were more likely to have IBS (10.7% vs 5.8%, p=0.029) and obesity (29% vs 4%, p<0.001) than healthy volunteers. Mixed-type IBS (IBS-M) was the most common subtype (74%) among patients with PCOS and IBS. There was a higher prevalence of psychiatric morbidities (total BSRS-5 score ≥10) in women with PCOS than in healthy women (11.4% vs 3.5%, p<0.001). Women with PCOS and IBS were more likely to have sleep difficulties (67.4% vs 30.9%, p<0.001) and psychiatric morbidities (21.7% vs 10.1%, p=0.019) than those without IBS. Anthropometrics, metabolic and hormonal profiles were similar between PCOS women with and without IBS. Among women with PCOS, those with both IBS and obesity had the highest risk of developing sleep difficulties (odds ratio: 5.91; 95% confidence interval: 1.77-19.77) and psychiatric distress (odds ratio: 4.39; 95% confidence interval: 1.26-15.29) than those without. Conclusion: Women with PCOS have increased IBS, obesity, sleep and psychiatric disturbances. The presence of IBS in PCOS women is associated with sleep and psychiatric disorders. The coexistence of obesity and IBS exacerbates sleep difficulties and psychiatric distress. Screening and management of IBS and obesity might be warranted to improve sleep and psychiatric disturbances in women with PCOS.

Meckel's Diverticulum Diagnosed by Balloon-Assisted Enteroscopy: A Multicenter Report from the Taiwan Association for the Study of Small Intestinal Diseases (TASSID).

BACKGROUND AND AIMS: Patients with Meckel's diverticulum (MD) are difficult to preoperatively diagnose because of its endoscopic inaccessibility. Balloon-assisted enteroscopy (BAE) allows endoscopic access to the entire small intestine. The aim of the current study was to investigate patients with MD diagnosed by BAE in Taiwan. METHODS: We conducted a retrospective, multicenter study of patients with MD who were diagnosed by BAE in Taiwan. The clinical characteristics, endoscopic features, histopathological findings, treatment methods, and outcomes were analyzed. RESULTS: A total of 55 patients with MD were enrolled (46 males and 9 females). The mean age at diagnosis was 34.1 years. Overt gastrointestinal bleeding (87.3%) was the primary indication for BAE, followed by abdominal pain (9.1%), suspected small bowel tumor (1.8%), and Crohn's disease follow-up (1.8%). The mean distance between the ileocecal valve and MD was 71.6 cm (regarding diagnostic yields: BAE-100%, capsule endoscopy-40%, Meckel's scan-35.7%, computed tomography-14.6%, small bowel series-12.5%, and angiography-11.1%; regarding endoscopic features of MD: a large ostium-89.1%, a small ostium-7.3%, and a polypoid mass-3.6%). Surgical treatment was performed in 76.4% patients, and conservative treatment was performed in 23.6% patients. The mean length of MD in 42 patients who underwent surgical resection was 5.2 cm (in 43 patients of MD with available histopathology: heterotopic gastric tissue, 42.4%, heterotopic gastric and pancreatic tissues, 7%; heterotopic pancreatic tissue, 4.7%; heterotopic colonic tissue, 2.3%; and a neuroendocrine tumor, 2.3%). CONCLUSIONS: The current study showed BAE is a very useful modality for detecting MD compared with other conventional modalities.

Incidence of suboptimal response to tumor necrosis factor antagonist therapy in inflammatory bowel disease in newly industrialised countries: The EXPLORE study.

BACKGROUND: Incidence of inflammatory bowel disease (IBD) is increasing in newly industrialised countries (NICs); however, data on suboptimal response to anti-tumor necrosis factor (anti-TNF) agents are limited. OBJECTIVES: To assess incidence and indicators of suboptimal response to first anti-TNF therapy in IBD patients in NICs. METHODS: A chart review was conducted in ten countries from Asia-Pacific (APAC), Latin America (LatAm), and Russia and the Middle East (RME) regions among patients diagnosed with ulcerative colitis (UC) or Crohn's disease (CD), initiating anti-TNF therapy in 2010-2015. The cumulative incidence of suboptimal response to anti-TNF therapy was assessed using the following indicators: dose escalation or discontinuation, augmentation with non-biologic therapy, IBD-related hospitalization, or surgery. RESULTS: The study included 1,674 patients (570 UC; 1,104 CD). At 24 months, 32.9% of UC (APAC: 45.1%; LatAm: 38.2%; RME: 23.8%) and 41.2% of CD patients (APAC: 54.1%; LatAm: 42.5%; RME: 29.5%) had experienced suboptimal response. The most frequent first indicator was non-biologic therapy augmentation in LatAm (41.7%), IBD-related hospitalization in RME (UC: 50.7%; CD:37.3%) and in APAC for CD (39.1%), and anti-TNF discontinuation in APAC for UC (38.3%). CONCLUSION: Suboptimal response to anti-TNF agents is common in IBD patients in NICs. Observed regional differences in the incidence and indicators may reflect local practice and anti-TNF restrictions in IBD management. NCT REGISTRATION NUMBER: NCT03090139.

Higher risk of advanced histology in adenoma less than 10 mm in fecal immunochemical test screening: Implication for management.

BACKGROUND AND AIM: Whether diminutive or small adenomas detected by fecal immunochemical tests (FITs) are associated with a higher risk of advanced histology remains unknown. We investigated the prevalence of advanced histology in diminutive and small adenomas detected by FIT and compared with that detected by colonoscopy screening. METHODS: We prospectively compared 1860 FIT-positive patients (FIT-positive cohort) and 6691 average-risk patients (screening colonoscopy cohort). Both groups underwent colonoscopies and were shown to have neoplastic lesions. The prevalence of advanced histology was determined, as was the associations with size and FIT positivity. RESULTS: We analyzed 3920 neoplastic lesions from the FIT-positive cohort and 9789 neoplastic lesions from the screening colonoscopy cohort. Eighty (4.3%) diminutive lesions in FIT-positive cohort had advanced histology but without any invasive cancer. Twenty-one patients in the FIT-positive cohort and 49 in the screening colonoscopy cohort with diminutive adenomas displayed advanced histology (3.5% vs 1.2%; adjusted odds ratio [aOR] = 2.99, 95% confidence interval [CI]: 1.77-5.06). Sixteen patients in the FIT-positive cohort (2.7%) with diminutive adenomas might have changed the surveillance interval if a resect-and-discard strategy was applied, with a higher likelihood compared with the screening colonoscopy cohort (aOR = 2.76, 95% CI: 1.53-4.99). CONCLUSIONS: Fecal immunochemical test screening detected more diminutive and small adenomas with advanced histology compared with colonoscopy screening. Its impact on current management of diminutive polyp is limited.

Endoscopic management of strictures in patients with Crohn's disease - A multi-center experience in Taiwan.

BACKGROUND/PURPOSE: Inflammatory bowel disease (IBD) is a chronic gastrointestinal (GI) disorder that causes relapsing inflammation and severe mucosal damage in the intestine. Crohn's disease (CD)-related stricturing complications are a major cause of surgery, disability, and reduced quality of life. Endoscopic balloon dilation (EBD) has been shown to reliably delay or prevent surgery in patients with stricturing CD. However, cases of EBD performed for stricture in CD in Taiwan are rare. In this study, we want to evaluate the experiences regarding EBD for stricturing CD in Taiwan. METHODS: We conducted a retrospective analysis of 9 medical centers in Taiwan. Patients with CD-related strictures who were treated with EBD were included and analyzed. RESULTS: In nine medical centers, a total of 26 CD patients (19 male, 7 female, mean disease duration 75.4 ± 65.2 months) underwent 42 EBD procedures during the study period. Among the subjects, an 83.3% (35/42) EBD success rate was seen, but 26.9% (7/26) patients underwent surgery after ineffective EBD. In the surgery group, the the small bowel strictures was high compared with the non-surgery group (p = 0.01). There were no significant differences in disease phenotype, disease duration or history of fistulizing disease. In the surgery group, immunosuppressant use was high, and 5-aminosalicylic acid (5-ASA) use was low compared with the non-surgery group. After EBD, the physicians tended to change the drugs, especially increasing the use of biologic agents. CONCLUSION: EBD is a safe and effective procedure for CD-related stricture, with a 83.3% success rate in Taiwan.

Adjunctive use of chromoendoscopy may improve the diagnostic performance of narrow-band imaging for small sessile serrated adenoma/polyp.

BACKGROUND AND AIM: Endoscopic diagnosis of sessile serrated adenoma/polyp (SSA/P) is challenging because of their subtle appearance. Narrow-band imaging (NBI) is useful for diagnosis, but its utility with concurrent chromoendoscopy (CE), especially to detect small SSA/P, is unproven. METHODS: This prospective study enrolled 367 consecutive patients who underwent screening colonoscopy with the finding of serrated polyps. Patients were divided into derivation and validation cohorts: Diagnostic criteria using different endoscopic modalities were generated by regression analysis in the derivation cohort and were validated in the validation cohort for sensitivity, specificity, and accuracy. RESULTS: There were 180 patients with 119 SSA/P and 147 hyperplastic polyps (HP) in the derivation cohort and 187 patients with 177 SSA/P and 125 HP in the validation cohort. With white-light endoscopy plus NBI, mucus cap, surface grooves, and expanded crypt were most associated with SSA/P. With white-light endoscopy plus CE, II-O pit pattern, mucus cap, and superficial telangiectasia were most associated with SSA/P. With the combined use of these three modalities, II-O pit pattern, mucus cap, and surface grooves were most associated with SSA/P. For large serrated polyp, NBI in combination with CE had a better accuracy than NBI alone (91% vs 86%, P = 0.025) to distinguish SSA/P from HP. CE alone had a better accuracy than NBI alone for distinguishing small SSA/P from small HP (85% vs 72%, P < 0.0001). CONCLUSION: Compared with NBI alone, adjunctive use of CE can improve the diagnostic accuracy for distinguishing SSA/P from HP, especially for small SSA/P.

Timing and Risk Factors for a Positive Fecal Immunochemical Test in Subsequent Screening for Colorectal Neoplasms.

BACKGROUND: Following a negative test, the performance of fecal immunochemical testing in the subsequent screening round is rarely reported. It is crucial to allocate resources to participants who are more likely to test positive subsequently following an initial negative result. OBJECTIVE: To identify risk factors associated with a positive result in subsequent screening. METHODS: Dataset was composed of consecutive participants who voluntarily underwent fecal tests and colonoscopy in a routine medical examination at the National Taiwan University Hospital between January 2007 and December 2011. Risk factor assessment of positive fecal test in subsequent screening was performed by using the Cox proportional hazards models. RESULTS: Our cohort consisted of 3783 participants during a 5-year period. In three rounds of subsequent testing, 3783, 1537, and 624 participants underwent fecal tests, respectively; 5.7%, 5.1%, and 3.9% tested positive, respectively, and the positive predictive values were 40.2%, 20.3%, and 20.8%, respectively. Age ≥60 years (adjusted hazard ratio: 1.53, 95% CI: 1.21-1.93) and male gender (1.32, 95% CI: 1.02-1.69) were risk factors; however, an interaction between age and gender was noted. Men had higher risk than women when they were <60 years of age (p = 0.002), while this difference was no longer observed when ≥60 years of age (p = 0.74). The optimal interval of screening timing for participant with baseline negative fecal test was 2 years. CONCLUSIONS: Following a negative test, older age and male gender are risk factors for a positive result in the subsequent rounds while the gender difference diminishes with age. Biennial screening is sufficient following a negative fecal test.

Effects of metabolic syndrome and findings from baseline colonoscopies on occurrence of colorectal neoplasms.

BACKGROUND & AIMS: Metabolic syndrome is associated with increased risk of colorectal neoplasm, but little is known about its effects on the occurrence of neoplasm after colonoscopy. We investigated the effects of metabolic syndrome on the risk of advanced neoplasm after colonoscopy. METHODS: We performed a prospective study of 4483 subjects age 50 years and older who underwent screening and surveillance colonoscopies as part of an annual health check-up at National Taiwan University Hospital. Baseline demographic data and colonoscopic findings were recorded. Subjects with either advanced adenoma or 3 or more adenomas detected at baseline were classified as high risk; those with fewer than 3 nonadvanced adenomas were classified as low risk; and those without any neoplastic lesions were classified as normal. The cumulative risk of detecting an advanced neoplasm during surveillance colonoscopies (3 and 5 years later) was correlated with risk group and metabolic syndrome. Hazard ratios (HRs) were calculated for occurrence of neoplasm according to baseline colonoscopic findings and clinical risk factors, including metabolic syndrome. RESULTS: Advanced neoplasms were detected during the surveillance colonoscopies in 1.3% of subjects in the normal group and in 2.4% of those in the low-risk group at 5 years, and in 8.5% of subjects in the high-risk group at 3 years. Subjects with metabolic syndrome had a significantly higher risk for subsequent advanced neoplasms (P < .0001). After stratification based on findings from baseline colonoscopies, the risk for neoplasm was significant in the normal (P < .001) and low-risk groups (P = .04), but not in the high-risk group (P = .48). In Cox regression analysis, metabolic syndrome had significant effects on the risk for advanced neoplasms in the normal (HR, 2.07; 95% confidence interval, 1.13-3.81) and low-risk groups (HR, 2.34; 95% confidence interval, 1.01-5.41), but not in the high-risk group. CONCLUSIONS: Metabolic syndrome is a significant risk factor for occurrence of an advanced adenoma after a negative or low-risk finding from a baseline colonoscopy. Metabolic syndrome should be considered in risk stratification for surveillance intervals.

Performance of a one-step fecal sample-based test for diagnosis of Helicobacter pylori infection in primary care and mass screening settings.

BACKGROUND/PURPOSE: An alternative screening test is needed to efficiently eradicate Helicobacter pylori from a population with prevalent upper gastrointestinal lesions. We evaluated the performance of a new one-step fecal test for H. pylori for diagnosis of H. pylori infection in Taiwan. METHODS: We developed a fecal test to detect H. pylori based on the immunochronomatographic assay and a mixture of monoclonal antibodies. We first recruited symptomatic patients from the primary care setting to evaluate fecal test performance using a reference standard consisting of (13)C urea breath test, rapid urease test, and histology. We also compared the performance of the fecal test with that of others. Next, we recruited asymptomatic participants from the mass screening setting to evaluate population attendance for the fecal test and compared its performance with that of (13)C urea breath test. RESULTS: In the primary care setting, 117 patients were recruited; H. pylori infection was confirmed in 58 (49.6%). Fecal test sensitivity, specificity, positive and negative predictive values, and accuracy were 88.0% [95% confidence interval (CI): 79.6-96.4%], 100%, 100%, 89.4% (95% CI, 82.0-96.8%), and 94% (95% CI, 89.7-98.3%), respectively. Fecal test specificity and positive predictive value were significantly higher than those of the serological test, whereas the sensitivity and negative predictive value were lower than those of the (13)C urea breath test (p < 0.05). In the mass screening setting, 2720 of 3520 invited individuals participated (77.3%; 95% CI, 76-78.7%); 649 (23.9%) showed positive results. Concordance rate and kappa statistic between the fecal test and (13)C urea breath test were 91.7% (563/614; 95% CI, 89.9-94.1%) and 0.78 (95% CI, 0.73-0.84), respectively. CONCLUSION: Given the acceptable sensitivity, excellent specificity, and high participation rate to screening, the one-step H. pylori stool antigen test is feasible for wide application in the community.

Association of esophageal inflammation, obesity and gastroesophageal reflux disease: from FDG PET/CT perspective.

OBJECTIVE: Gastroesophageal reflux disease (GERD) is associated with bothersome symptoms and neoplastic progression into Barrett's esophagus and esophageal adenocarcinoma. We aim to determine the correlation between GERD, esophageal inflammation and obesity with 18F-Fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT). METHODS: We studied 458 subjects who underwent a comprehensive health check-up, which included an upper gastrointestinal endoscopy, FDG PET/CT and complete anthropometric measures. GERD symptoms were evaluated with Reflux Disease Questionnaire. Endoscopically erosive esophagitis was scored using the Los Angeles classification system. Inflammatory activity, represented by standardized uptake values (SUVmax) of FDG at pre-determined locations of esophagus, stomach and duodenum, were compared. Association between erosive esophagitis, FDG activity and anthropometric evaluation, including body mass index (BMI), waist circumference, visceral and subcutaneous adipose tissue volumes were analyzed. RESULTS: Subjects with erosive esophagitis (n = 178, 38.9%) had significantly higher SUVmax at middle esophagus (2.69±0.74 vs. 2.41±0.57, P<.001) and esophagogastric junction (3.10±0.89 vs. 2.38±0.57, P<.001), marginally higher at upper esophageal sphincter (2.29±0.42 vs. 2.21±0.48, P = .062), but not in stomach or duodenum. The severity of erosive esophagitis correlated with SUVmax and subjects with Barrett's esophagus had the highest SUVmax at middle esophagus and esophagogastric junction. Heartburn positively correlated with higher SUVmax at middle oesophagus (r = .262, P = .003). Using multivariate regression analyses, age (P = .027), total cholesterol level (P = .003), alcohol drinking (P = .03), subcutaneous adipose tissue (P<.001), BMI (P<.001) and waist circumference (P<.001) were independently associated with higher SUVmax at respective esophageal locations. CONCLUSIONS: Esophageal inflammation demonstrated by FDG PET/CT correlates with endoscopic findings and symptomatology of GERD. Obesity markers, both visceral and general, are independent determinants of esophageal inflammation.

Metabolic syndrome and smoking may justify earlier colorectal cancer screening in men.

BACKGROUND: Gender, smoking, and metabolic syndrome (MetS) are important risk factors of colorectal neoplasm. Whether presence of these factors may warrant earlier screening remains unclear. OBJECTIVE: To compare age- and gender-specific risk of colorectal neoplasms in association with smoking and MetS under endoscopic or stool-based screening. DESIGN: Cross-sectional observational study. SETTING: Screening center in a university hospital in Taiwan. PATIENTS: A cohort of 10,884 average-risk individuals who received concurrent screening colonoscopy and fecal immunochemical testing (FIT). MAIN OUTCOME MEASUREMENTS: First, the prevalence of colorectal neoplasms and positive predictive value of FIT relative to age, gender, smoking, and MetS. Second, the number of colonoscopies needed to detect 1 advanced neoplasm with different strategies. RESULTS: Male smokers aged 40 to 49 years had a significantly higher prevalence of advanced neoplasms and positive predictive value of stool tests than nonsmoking counterparts. The prevalence of advanced neoplasms in concurrent MetS and smoking (6.2%) or smoking alone (3.8%) men aged 40 to 49 years was higher than that of average-risk women aged 50 to 59 years (2.1%) (P = .03 and .04, respectively). The number of colonoscopies needed to detect 1 advanced neoplasm in men aged 40 to 49 years with concurrent MetS and smoking, smoking, MetS, and women aged 50 to 59 years was, respectively, 14.6, 24.8, 39.8, and 47.4 in the colonoscopy scenario and 1.7, 4.6, 5.7, and 8.3 in the FIT scenario. LIMITATION: Self-selective bias may exist for subjects voluntarily submitted to health check-ups. CONCLUSIONS: MetS and smoking significantly impact both the prevalence of colorectal neoplasms and the diagnostic yields of screening tests in men aged 40 to 49 years. Whether our findings justify earlier screening in this subgroup requires further study.

Accuracy of faecal occult blood test and Helicobacter pylori stool antigen test for detection of upper gastrointestinal lesions.

OBJECTIVE: Highly sensitive guaiac-based faecal occult blood (Hemoccult SENSA) and Helicobacter pylori stool antigen testing might help detect upper gastrointestinal lesions when appended to a colorectal cancer screening programme with faecal immunochemical testing. We evaluated the diagnostic accuracies of two stool tests in detecting upper gastrointestinal lesions. DESIGN: Cross-sectional design. SETTING: Hospital-based and community-based screening settings. PARTICIPANTS: A hospital-based deviation cohort of 3172 participants to evaluate test performance and a community-based validation cohort of 3621 to verify the findings. INTERVENTIONS: Three types of stool tests with bidirectional endoscopy as the reference standard. OUTCOMES: Sensitivity, specificity and positive and negative likelihood ratios. RESULTS: For detecting upper gastrointestinal lesions in cases with negative immunochemical tests, the sensitivity, specificity, and positive and negative likelihood ratios of the guaiac-based and H pylori antigen tests were 16.3% (95% CI 13.3% to 19.8%), 90.1% (88.9% to 91.2%), 1.64 (1.31 to 2.07), and 0.93 (0.89 to 0.97), respectively, and 52.5% (48.1% to 56.9%), 80.6% (79.0% to 82.1%), 2.71 (2.41 to 3.04) and 0.59 (0.54 to 0.65), respectively. For detecting upper gastrointestinal lesions in cases with normal colonoscopy, the results of the guaiac-based and H pylori antigen tests were 17.9% (14.8% to 21.5%), 90.1% (88.9% to 91.2%), 1.81 (1.45 to 2.26) and 0.91 (0.87 to 0.95), respectively, and 53.1% (48.6% to 57.4%), 80.7% (79.1% to 82.2%), 2.75 (2.45 to 3.08) and 0.58 (0.53 to 0.64), respectively. Within the community, positive predictive values of the immunochemical and H pylori antigen tests were 36.0% (26.0% to 46.0%) and 31.9% (28.3% to 35.5%), respectively, for detecting lower and upper gastrointestinal lesions, which were similar to expected values. CONCLUSIONS: The H pylori stool antigen test is more accurate than the guaiac-based test in the screening of upper gastrointestinal lesions in a population with high prevalence of H pylori infection and upper gastrointestinal lesions. It is applicable to add the H pylori antigen test to the immunochemical test for pan detection. TRIAL REGISTRATION: NCT01341197 (ClinicalTrial.gov).

Association between early stage colon neoplasms and false-negative results from the fecal immunochemical test.

BACKGROUND & AIMS: The fecal immunochemical test (FIT) can identify patients with advanced colorectal neoplasms, but it also has a high rate of false-negative results. It would be helpful to characterize colorectal neoplasms that are not detected by FIT to aid in development of new tests. We characterized colorectal neoplasms from patients who had negative results from the FIT. METHODS: We analyzed data from 18,296 subjects who were screened for colorectal cancer by colonoscopy and the FIT at the Health Management Center of National Taiwan University Hospital from September 2005 through September 2010. We identified 4045 subjects with colorectal neoplasms (3385 with nonadvanced adenomas, 632 with advanced adenomas, and 28 with cancer). We analyzed the sensitivity of the FIT in identifying these patients, along with information on lesion size, location, and morphology. RESULTS: The FIT identified patients with nonadvanced adenomas, advanced adenomas, and cancer with sensitivity values of 10.6% (95% confidence interval [CI], 10.2%-12.3%), 28.0% (95% CI, 24.6%-31.7%), and 78.6% (95% CI, 58.5%-91.0%), respectively. The FIT detected proximal advanced adenomas and nonpolypoid lesions with lower levels of sensitivity than distal advanced adenomas; it had a high false-negative rate in detection of adenomas <15 mm (adjusted odds ratio, 2.85; 95% CI, 1.79-4.54) and nonpolypoid adenomas (adjusted odds ratio, 2.15; 95% CI, 1.22-3.80), after adjusting for demographic characteristics, colonoscopy findings, and potential confounders. The FIT produced a higher percentage of false-negative results in detection of carcinoma in situ and T1 cancer than in T2-T4 cancers (66.7% sensitivity vs 100%; P = .049). CONCLUSIONS: The FIT produces a high rate of false-negative results for patients with small or nonpolypoid adenomas. Early-stage cancers are associated with a high rate of false-negative results from the FIT.