Deep Learning Model Using Stool Pictures for Predicting Endoscopic Mucosal Inflammation in Patients With Ulcerative Colitis.

INTRODUCTION: Stool characteristics may change depending on the endoscopic activity of ulcerative colitis (UC). We developed a deep learning model using stool photographs of patients with UC (DLSUC) to predict endoscopic mucosal inflammation. METHODS: This was a prospective multicenter study conducted in 6 tertiary referral hospitals. Patients scheduled to undergo endoscopy for mucosal inflammation monitoring were asked to take photographs of their stool using smartphones within 1 week before the day of endoscopy. DLSUC was developed using 2,161 stool pictures from 306 patients and tested on 1,047 stool images from 126 patients. The UC endoscopic index of severity was used to define endoscopic activity. The performance of DLSUC in endoscopic activity prediction was compared with that of fecal calprotectin (Fcal). RESULTS: The area under the receiver operating characteristic curve (AUC) of DLSUC for predicting endoscopic activity was 0.801 (95% confidence interval [CI] 0.717-0.873), which was not statistically different from the AUC of Fcal (0.837 [95% CI, 0.767-0.899, DeLong P = 0.458]). When rectal-sparing cases (23/126, 18.2%) were excluded, the AUC of DLSUC increased to 0.849 (95% CI, 0.760-0.919). The accuracy, sensitivity, and specificity of DLSUC in predicting endoscopic activity were 0.746, 0.662, and 0.877 in all patients and 0.845, 0.745, and 0.958 in patients without rectal sparing, respectively. Active patients classified by DLSUC were more likely to experience disease relapse during a median 8-month follow-up (log-rank test, P = 0.002). DISCUSSION: DLSUC demonstrated a good discriminating power similar to that of Fcal in predicting endoscopic activity with improved accuracy in patients without rectal sparing. This study implies that stool photographs are a useful monitoring tool for typical UC.

Comparison of the Pharmacokinetics of CT-P13 Between Crohn's Disease and Ulcerative Colitis.

BACKGROUND: We aimed to compare trough infliximab levels and the development of antidrug antibody (ADA) for 1 year between Crohn's disease (CD) and ulcerative colitis (UC) patients who were biologic-naive, and to evaluate their impact on clinical outcomes. METHODS: This was a prospective, multicenter, observational study. Biologic-naive patients with moderate to severe CD or UC who started CT-P13, an infliximab biosimilar, therapy were enrolled. Trough drug and ADA levels were measured periodically for 1 year after CT-P13 initiation. RESULTS: A total of 267 patients who received CT-P13 treatment were included (CD 168, UC 99). The rates of clinical remission (72% vs. 32.3%, P <0.001) at week 54 were significantly higher in CD than in UC. The median trough drug level (µg/mL) was significantly higher in CD than in UC up to week 14 (week 2, 18.7 vs. 14.7, P <0.001; week 6, 12.5 vs. 8.6, P <0.001; week 14, 3.4 vs. 2.5, P =0.001). The median ADA level (AU/mL) was significantly lower in CD than in UC at week 2 (6.3 vs. 6.5, P =0.046), week 30 (7.9 vs. 11.8, P =0.007), and week 54 (9.3 vs. 12.3, P =0.032). Development of ADA at week 2 [adjusted odds ratio (aOR)=0.15, P =0.026], initial C-reactive protein level (aOR=0.87, P =0.032), and CD over UC (aOR=1.92, P <0.001) were independent predictors of clinical remission at week 54. CONCLUSION: Infliximab shows more favorable pharmacokinetics, including high drug trough and low ADA levels, in CD than in UC, which might result in better clinical outcomes for 1-year infliximab treatment in CD patients.

Effectiveness and safety of adalimumab in patients with intestinal Behçet's disease: a real-world prospective observational study in South Korea.

BACKGROUND: Intestinal Behçet's disease (BD) is characterized by typical gastrointestinal ulcers in patients with BD followed by complications such as bleeding, perforation and fistula. Biologic agents are currently under active investigation to delay the disease course. Various data regarding infliximab are available, but there is relatively lack of data regarding adalimumab. METHODS: This was a multicenter, real-world prospective observational study to evaluate the effectiveness and safety of adalimumab in intestinal BD. The primary endpoint was disease activity at each follow up, including disease activity index for intestinal Behçet's disease (DAIBD), serum C-reactive protein (CRP) level, and endoscopic findings. The secondary endpoint was the incidence of adverse drug reactions (ADRs). RESULTS: A total of 58 patients were enrolled and 8 of them were excluded. Adverse events were reported in 72.0% of patients with 122 events. ADRs were reported in 24.0% with 28 events. For adverse events, arthralgia was most commonly reported (13.1%: 16/122) and only one experienced critical adverse event (0.82%, 1/122: death due to stroke). On multivariable regression analysis, a longer disease duration was significantly associated with decreased ADRs [Odds ratio 0.976 (0.953-0.999, 95% CI); p = 0.042]. Clinical response rates as assessed by DAIBD were 90.9% at Week 12 and 89.7% at Week 56, respectively. The mean serum CRP level at baseline was significantly decreased after 12 weeks (3.91 ± 4.93 to 1.26 ± 2.03 mg/dL; p = 0.0002). CONCLUSION: Adalimumab was found to be safe and effective in Korean patients with intestinal BD. A longer disease duration was significantly associated with decreased ADRs.

Incidence of colonoscopy-related perforation and risk factors for poor outcomes: 3-year results from a prospective, multicenter registry (with videos).

BACKGROUND AND AIMS: Perforation is a life-threatening adverse event of colonoscopy that often requires hospitalization and surgery. We aimed to prospectively assess the incidence of colonoscopy-related perforation in a multicenter registry and to analyze the clinical factors associated with poor clinical outcomes. METHODS: This prospective observational study was conducted at six tertiary referral hospitals between 2017 and 2020, and included patients with colonic perforation after colonoscopy. Poor clinical outcomes were defined as mortality, surgery, and prolonged hospitalization (> 13 days). Logistic regression was used to identify factors associated with poor clinical outcomes. RESULTS: Among 84,673 patients undergoing colonoscopy, 56 had colon perforation (0.66/1000, 95% confidence interval [CI] 0.51-0.86). Perforation occurred in 12 of 63,602 diagnostic colonoscopies (0.19/1000, 95% CI 0.11-0.33) and 44 of 21,071 therapeutic colonoscopies (2.09/1000, 95% CI 1.55-2.81). Of these, 15 (26.8%) patients underwent surgery, and 25 (44.6%) patients had a prolonged hospital stay. One patient (1.8%) died after perforation from a diagnostic colonoscopy. In the multivariate analysis, diagnostic colonoscopy (adjusted odds ratio [aOR] 196.43, p = 0.025) and abdominal rebound tenderness (aOR 17.82, p = 0.012) were independent risk factors for surgical treatment. The location of the sigmoid colon (aOR 18.57, p = 0.048), delayed recognition (aOR 187.71, p = 0.008), and abdominal tenderness (aOR 63.20, p = 0.017) were independent risk factors for prolonged hospitalization. CONCLUSIONS: This prospective study demonstrated that the incidence of colonoscopy-related perforation was 0.66/1000. The incidence rate was higher in therapeutic colonoscopy, whereas the risk for undergoing surgery was higher in patients undergoing diagnostic colonoscopy. Colonoscopy indication (diagnostic vs. therapeutic), physical signs, the location of the sigmoid perforation, and delayed recognition were independent risk factors for poor clinical outcomes in colonoscopy-related perforation.

Comparison of 1-Year Colectomy Risk Between the US and Korean Patients with Acute Severe Ulcerative Colitis: A Propensity Score Matching Analysis.

BACKGROUND: Colectomy risk after acute severe ulcerative colitis (ASUC) has not been compared between Eastern and Western countries. We compared the 1-year colectomy risk after ASUC between Korea and the USA. METHODS: Data on patients admitted for ASUC to five tertiary referral hospitals in Korea and Mount Sinai Hospital, New York, the USA, between January 2015 and January 2019 were reviewed retrospectively. For comparability between groups, a 1:1 propensity score matching (PSM) was performed. The primary outcome was colectomy, and secondary outcomes were mortality, readmission, and venous thromboembolism (VTE) within 1-year of the index admission for ASUC. The risk of each outcome was compared using Cox proportional hazards model in pre-matched cohort and Kaplan-Meier analysis with log-rank test in post-matched cohort. RESULTS: 290 ASUC patients were included in the study (121 Korea, 169 the USA). After PSM, 56 patients were selected in each group with no significant differences in baseline variables. At 1 year after ASUC, colectomy was less common in Korea than in the USA [3 (5.4%) vs. 24 (42.9%), p < 0.001]. The cumulative colectomy risk was significantly higher in the USA than in Korea in pre-matched cohort [adjusted hazard ratio 7.89, 95% confidence interval 3.23 to 19.22] and in post-matched cohort (log-rank p < 0.001), while there was no difference in cumulative risk of mortality, readmission, and VTE. CONCLUSION: Colectomy risk within 1 year of ASUC is significantly higher in the USA than in Korea. We observed no differences in mortality, readmission, and VTE between the two groups.

Antioxidant Analogue 6-Amino-2,4,5-Trimethylpyridin-3-ol Ameliorates Experimental Colitis in Mice.

BACKGROUND: Oxidative stress has been suggested to be a factor contributing to the disease severity of inflammatory bowel disease (IBD). BJ-1108, a derivative of 6-amino-2,4,5-trimethylpyridin-3-ol, is reported to significantly inhibit the generation of reactive oxygen species (ROS) in vitro. However, whether this molecule affects intestinal inflammation is largely unknown. We aimed to investigate the effect of BJ-1108 on dextran sulfate sodium (DSS)-induced experimental colitis in mice. METHODS: Colitis was induced in mice with DSS, and disease severity was estimated by evaluating body weight, colon length, histology, immune cell infiltration, and intestinal permeability. We examined the protective effects of BJ-1108 on barrier function using Caco-2 cells. Last, we estimated the impact of BJ-1108 on the phosphorylation of NF-kB, PI3K/AKT, and mitogen-activated protein kinases. RESULTS: Mice treated with BJ-1108 exhibited improved disease severity, as indicated by evaluations of body weight, histological scores, spleen weight, and infiltrates of T cells and macrophages. The administration of BJ-1108 inhibited the colonic mRNA expression of IL-6 and IL-1ß in vivo. Additionally, BJ-1108 limited intestinal permeability and enhanced the expression of tight junction (TJ) proteins such as claudin-1 and claudin-3 in the DSS-induced colitis model. In an in vitro model using Caco-2 cells, BJ-1108 ameliorated cytokine-induced ROS generation in a dose-dependent manner and remarkably recovered barrier dysfunction as estimated by evaluating transepithelial electrical resistance and TJ protein expression. BJ-1108 suppressed the NF-kB/ERK/PI3K pathway. CONCLUSIONS: This study demonstrated that BJ-1108 ameliorated intestinal inflammation in an experimental colitis mouse model, suggesting possible therapeutic implications for IBD.

Low Bone Mineral Density in Young Patients Newly Diagnosed with Inflammatory Bowel Disease.

BACKGROUND: The prevalence and risk factors of low bone mineral density (BMD) in Asian patients newly diagnosed with inflammatory bowel disease (IBD) have not been fully suggested. AIMS: We aimed to examine the prevalence and risk factors of low BMD in young Korean patients newly diagnosed with IBD. METHODS: We prospectively enrolled 132 patients aged less than 50 years and newly diagnosed with IBD from six tertiary referral centers in Korea between November 2014 and April 2017. BMD was measured by dual-energy X-ray absorptiometry, and then the Z-score was determined. We defined low BMD as a Z-score ≤ - 1.0. RESULTS: Of 68 patients with ulcerative colitis (UC), 22 (32.4%) had low BMD. Also, of 64 patients with Crohn's disease (CD), 24 (37.5%) showed low BMD. Results from multivariate regression analysis identified the risk factors for low BMD as a high level of alkaline phosphatase (ALP) (≥ 140 U/L) (P = 0.010) in UC patients, and being underweight (body mass index ≤ 18.5 kg/m2) (P = 0.017) in CD patients. CONCLUSIONS: Our study showed that about one-third of newly diagnosed IBD Asian patients had low BMD. The clinical factors associated with low BMD were a high level of ALP in UC patients, and being underweight, in CD patients. Therefore, measurements of BMD in young patients should be considered at the diagnosis of IBD.

Fecal calprotectin is more accurate than fecal immunochemical test for predicting mucosal healing in quiescent ulcerative colitis: a prospective multicenter study.

Objective: Non-invasive stool tests, including the fecal immunochemical test (FIT) and fecal calprotectin (FC), are reliable biomarkers for mucosal healing (MH) in ulcerative colitis (UC). However, which fecal test is superior for predicting MH in inactive UC patients requires evaluation. We aimed to compare the accuracy of FIT and FC results for predicting MH in quiescent UC patients.Methods: This prospective, multicenter study was conducted at three tertiary hospitals. UC patients in clinical remission for at least three months underwent colonoscopy and MH was evaluated using the Mayo endoscopic sub-score (MES). The receiver operating characteristic (ROC) curve and cutoff value with the best accuracy for predicting MH were assessed.Results: Among 127 patients, 65 (51.2%) showed MH (MES = 0). The area under the curve (AUC) for predicting MH (MES = 0) was significantly higher for FC than for FIT (AUC 0.858 (95% confidence interval (CI) 0.784-0.913) vs. 0.707 (95% CI 0.620-0.784), p < .001); there was no difference when MH included MES = 1 (MES ≤ 1) (AUC 0.820 (95% CI 0.742-0.883) vs. 0.813 (95% CI 0.734-0.877), p = .891). When the cutoff value was 70 µg/g for FC and 10 ng/mL for FIT, the sensitivity, specificity, positive predictive value and negative predictive value were 89.2, 71, 76.3, and 86.3, respectively, for FC and 92.3, 50, 65.9, and 86.1, respectively, for FIT.Conclusion: FC is more accurate than FIT for predicting MH in quiescent UC patients. The superiority of FC might be related to the distinctive performance of FC in differentiating inflammatory levels, particularly in low-grade mucosal activity.

Disease Activity Patterns Recorded Using a Mobile Monitoring System Are Associated with Clinical Outcomes of Patients with Crohn's Disease.

BACKGROUND: Usefulness of a mobile monitoring system for Crohn's disease (CD) has not been evaluated. We aimed to determine whether disease activity patterns depicted using a web-based symptom diary for CD could indicate disease clinical outcomes. METHODS: Patients with CD from tertiary hospitals were prospectively invited to record their symptoms using a smartphone at least once a week. Disease activity patterns for at least 2 months were statistically classified into good and poor groups based on two factors in two consecutive time frames; the degree of score variation (maximum-minimum) in each frame and the trend (upward, stationary, or downward) of patterns indicated by the difference in the mean activity scores between two time frames. RESULTS: Overall, 220 (82.7%) and 46 (17.3%) patients were included in good and poor groups, respectively. Poor group was significantly more associated with disease-related hospitalization (p = 0.004), unscheduled hospital visits (p = 0.005), and bowel surgery (p < 0.001) during the follow-up period than good group. In the multivariate analysis, poor patterns [odds ratio (OR) 2.62, p = 0.006], stricturing (OR 4.19, p < 0.001) or penetrating behavior (OR 2.27, p = 0.012), and young age at diagnosis (OR 1.06, p = 0.019) were independently associated with disease-related hospitalization. Poor patterns (OR 4.06, p = 0.006) and an ileal location (OR 5.79, p = 0.032) remained independent risk factors for unscheduled visits. Poor patterns (OR 15.2, p < 0.001) and stricturing behavior (OR 9.77, p = 0.004) were independent risk factors for bowel surgery. CONCLUSION: The disease activity patterns depicted using a web-based symptom diary were useful indicators of poor clinical outcomes in patients with CD.

Comparison of 4-L Polyethylene Glycol and 2-L Polyethylene Glycol Plus Ascorbic Acid in Patients with Inactive Ulcerative Colitis.

BACKGROUND: Although colonoscopy preparation may cause symptom flares in patients with ulcerative colitis (UC), little is known about the standard preparation regimen in this population. AIM: We aimed to compare 4L polyethylene glycol (4L-PEG) with 2L polyethylene glycol plus ascorbic acid (2L-PEG-Asc) in quiescent UC patients. METHODS: Patients with inactive UC undergoing colonoscopy for surveillance or checkup of mucosal healing were prospectively enrolled at 5 tertiary hospitals. They were randomly assigned to 4L-PEG and 2L-PEG-Asc groups. The Boston Bowel Preparation Scale (BBPS) was used for the preparation quality. Symptoms were assessed using the Simple Clinical Colitis Activity Index (SCCAI) before colonoscopy, at 1 and 4 weeks after the procedure. RESULTS: Overall, 109 patients were included in the study (4L-PEG group 53, 2L-PEG-Asc group 56, the mean age at diagnosis 42.25 years, male 77). The quality of preparation was comparable between the groups (BBPS ≥ 6, 96.2 vs. 92.9%, p = 0.679). Although 26 patients (23.8%) had increased SCCAI scores within 4 weeks after colonoscopy, resulting in a medication dose-up or add-on in 3 patients (2.7%), the rise in scores was not different between the groups. No serious adverse events during preparation were observed in either group. However, the 2L-PEG-Asc group was more likely to be willing to repeat the preparation with the same agent than the 4L-PEG group (82.1 vs. 64.2%, respectively, p = 0.034). CONCLUSION: PEG-based regimens with different volumes are equally effective and safe in inactive UC patients. 2L-PEG-Asc is more acceptable in this population as indicated by the willingness for further usage.

Evaluation of the Efficacy and Safety of DA-9601 versus Its New Formulation, DA-5204, in Patients with Gastritis: Phase III, Randomized, Double-Blind, Non-Inferiority Study.

This study compared the efficacy of DA-9601 (Dong-A ST Co., Seoul, Korea) and its new formulation, DA-5204 (Dong-A ST Co.), for treating erosive gastritis. This phase III, randomized, multicenter, double-blind, non-inferiority trial randomly assigned 434 patients with endoscopically proven gastric mucosal erosions into two groups: DA-9601 3 times daily or DA-5,204 twice daily for 2 weeks. The final analysis included 421 patients (DA-5204, 209; DA-9601, 212). The primary endpoint (rate of effective gastric erosion healing) and secondary endpoints (cure rate of endoscopic erosion and gastrointestinal [GI] symptom relief) were assessed using endoscopy after the treatment. Drug-related adverse events (AEs), including GI symptoms, were also compared. At week 2, gastric healing rates with DA-5204 and DA-9601 were 42.1% (88/209) and 42.5% (90/212), respectively. The difference between the groups was -0.4% (95% confidence interval, -9.8% to 9.1%), which was above the non-inferiority margin of -14%. The cure rate of gastric erosion in both groups was 37.3%. The improvement rates of GI symptoms with DA-5204 and DA-9601 were 40.4% and 40.8%, respectively. There were no statistically significant differences between the two groups in both secondary endpoints. AEs were reported in 18 (8.4%) patients in the DA-5204 group and 19 (8.8%) in the DA-9601 group. Rates of AE were not different between the two groups. No serious AE or adverse drug reaction (ADR) occurred. These results demonstrate the non-inferiority of DA-5204 compared to DA-9601. DA-5204 is as effective as DA-9601 in the treatment of erosive gastritis. Registered randomized clinical trial at ClinicalTrials.gov (NCT02282670).

Endoscopic resection as the first-line treatment for early colorectal cancer: comparison with surgery.

INTRODUCTION: Endoscopic resection has emerged as an alternative therapeutic option for selected cases of early colorectal cancer. However, even now, few data are available on the comparative effectiveness of endoscopic versus surgical resection of early colorectal cancer. The aim of our study was to compare the clinical outcomes in patients with early colorectal cancer who underwent endoscopic resection and those who underwent surgical resection. METHODS: 292 early colorectal cancer lesions in 287 patients who were treated with either endoscopic resection or colorectal surgery (open or laparoscopic colorectal resection) between January 2005 and December 2010 were retrospectively analyzed. After excluding 54 deep submucosal lesions [and/or tumor budding (Grade 2 or 3)], a total of 168 lesions with mucosal/superficial submucosal invasion were treated by endoscopic resection, and 70 lesions with mucosal/superficial submucosal invasion were treated by colorectal surgery. RESULTS: In the endoscopic resection group, the en bloc resection rate and the complete resection rate were 91.1 and 91.1%, respectively. In the colorectal surgery group, both the en bloc resection rate and the curative resection rate were 100%. However, using Log rank test in Kaplan-Meier curve, no significant difference in recurrence rate (including metachronous cancer) during the median follow-up period of 37 months (range, 6-98 months) was observed between the two groups (p = 0.647). In addition, a similar morbidity rate was observed for endoscopic resection compared with surgery (5.4 vs. 5.7%, p = 0.760). A significantly shorter hospital stay was observed in the endoscopic resection group than colorectal surgery group [median 2 days (range, 2-29) vs. median 10 days (range, 7-37), p < 0.001). CONCLUSION: We suggest that endoscopic resection, being equally effective but less invasive than surgery, can be the first-line treatment for well selected early colorectal cancer.

A tailored approach for endoscopic treatment of small rectal neuroendocrine tumor.

INTRODUCTION: Resection of rectal neuroendocrine tumors (NETs) less than 1 cm in diameter can be performed using various endoscopic techniques. Endoscopic mucosal resection (EMR) traditionally had suboptimal complete resection rate compared to endoscopic submucosal resection with band ligation (ESMR-L). However, the previous studies did not consider the characteristics of rectal NETs. The aim of our study is to compare the efficacy of ESMR-L and EMR using tailored approach according to the characteristics of rectal NETs. METHODS: 82 rectal NETs in 77 patients treated by ESMR-L (n = 48) or EMR (n = 34) between September 2007 and October 2012 were retrospectively analyzed. ESMR-L was used for flat-type tumors or tumors with non-lifting sign after submucosal injection. Conventional EMR was used for elevated-type tumors or tumors with well-lifting sign after submucosal injection. RESULTS: The pathological complete resection rate was higher in the ESMR-L group (45 lesions, 93.8%) compared with the EMR group (30 lesions, 88.2%); however, this difference was not significant (p = 0.441). Overall complication did not differ significantly between the ESMR-L group and the EMR group (p = 0.774). There was one case of a remnant lesion in the ESMR-L group, which was managed by EMR after circumferential pre-cutting (EMR-P), and no recurrence has been detected in either the ESMR-L or EMR group. CONCLUSIONS: ESMR-L and EMR procedures could have a similar excellent complete resection rate, if we select the endoscopic resection technique according to the characteristics of the small rectal NETs.

Endoscopic resection as a first therapy for gastric epithelial atypia: is it reasonable?

BACKGROUND AND AIMS: Gastric atypical cell (GAC), an indefinite pathologic finding, often requires repeated biopsy or other diagnostic treatments, such as endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), or operation (OP). The aim of this study was to analyze the initial endoscopic and histologic findings of GAC and to discuss the necessity of EMR/ESD at establishing a correct diagnosis. METHODS: This retrospective study enrolled 96 patients proven as GAC on index forceps biopsy. ESD (17/96, 17.7%), EMR (5/96, 5.2%), OP (20/96, 20.8%), and other treatment or follow-up (54/96, 56.3%) were performed. We analyzed the initial endoscopic and histologic characteristics of GAC lesions, predictive of neoplasm. RESULTS: After diagnostic modalities, the final pathologic diagnoses were cancer (36/96, 37.6%), dysplasia (9/96, 9.4%), and non-neoplasm (51/96, 53.0%). In univariate analysis, age [odds ratio (OR) 1.04, 95% confidence interval (CI) 1.01-1.07], lesion size of 10 mm or greater (OR 3.94, 95% CI 1.61-9.61), lesion with depressed type (OR 2.50, 95% CI 1.09-5.72), and presence of H. pylori (OR 2.83, 95% CI 1.11-7.25) were risk factors for neoplasm. In multivariate analysis, lesion size of 10 mm or greater (OR 3.63, 95% CI 1.23-10.66), lesion with depressed type (OR 2.86, 95% CI 1.11-7.38) were independent risk factors for cancer. CONCLUSION: Considering the neoplastic risk of GAC, which could be missed on biopsy, more comprehensive tissue sampling via EMR/ESD might be necessary to establish a definite diagnosis.

Inter-observer agreement in the endoscopic classification of colorectal laterally spreading tumors: a multicenter study between experts and trainees.

BACKGROUND AND AIM: The risk of cancer varies with the subtype of colorectal "laterally spreading tumors" (LSTs). However, visual interpretations vary among endoscopists. The aim of this study was to evaluate inter-observer agreement and accuracy in the endoscopic classification of LST subtypes among experts and trainees. METHODS: In total, 40 LST images were collected and reviewed independently by 14 gastroenterology experts and 10 trainees. All investigators recorded their findings as one of the following four categories: homogeneous, nodular mixed, flat-elevated, and pseudo-depressed. Agreement was assessed in terms of the kappa (κ) statistic and AC1 estimate. Accuracy is reported as percentage agreement with the gold standard, based on the gross morphology of the resected specimens. RESULTS: Of the possible 91 pair-wise κ estimates among experts, 41 (45.1%) were >0.75, indicating excellent agreement, while only 2 (4.44%) of the 45 pair-wise κ estimates among trainees were >0.75. Agreements for individual LST subtypes in the trainee group were significantly lower than those in the expert group. The κ and AC1 estimates showed similar values in individual subtypes of LSTs. The overall accuracy of LST was also significantly higher for the experts than the trainees (85.9 vs. 72.5%, P < 0.001). Notably, the flat-elevated subtype showed the lowest agreement and accuracy and was frequently misclassified as the pseudo-depressed subtype by both groups. CONCLUSIONS: Inter-observer agreement and accuracy for LST subtype classification differ significantly between experts and trainees. Implementation of an adequate training system for beginners is necessary to better identify colorectal LSTs.

Self-screening questionnaire for perianal fistulizing disease in patients with Crohn's disease.

BACKGROUND/AIMS: A poor prognostic factor for Crohn's disease (CD) includes perianal fistulizing disease, including perianal fistula and/or perianal abscess. Currently, a tool to assess perianal symptoms in patients with CD remains nonexistent. This study aimed to develop a perianal fistulizing disease self-screening questionnaire for patients with CD. METHODS: This prospective pilot study was conducted at three tertiary referral centers between January 2019 and May 2020. We formulated questions on perianal symptoms, including tenesmus, anal discharge, bleeding, pain, and heat. A 4-point Likert scale was used to rate each question. Patients with CD completed a questionnaire and underwent pelvic magnetic resonance imaging (MRI). RESULTS: Overall, 93 patients were enrolled, with 51 (54.8%) diagnosed with perianal fistulizing disease, as determined by pelvic MRI. The Spearman correlation findings demonstrated that anal pain (p = 0.450, p < 0.001) and anal discharge (p = 0.556, p < 0.001) were the symptoms that most significantly correlated with perianal disease. For anal pain and discharge, the area under the receiver operating characteristic curve of the scores was significantly higher than that of the combined score for all five symptoms (0.855 vs. 0.794, DeLong's test p = 0.04). For the two symptoms combined, the sensitivity, specificity, and positive predictive and negative predictive values were 88.2, 73.8, 80.4, and 83.8%, respectively, with 81.7% accuracy for detecting perianal fistulizing disease. CONCLUSION: This study indicates that simple questions regarding anal pain and discharge can help accurately identify the presence of perianal fistulizing disease in patients with CD.

Mobile monitoring system detects the disease activity pattern and shows the association with clinical outcomes in patients with newly diagnosed Crohn's disease.

We aimed to determine whether Crohn's disease (CD) activity patterns assessed via a web-based symptom diary can help predict clinical outcomes in patients with newly diagnosed CD. Patients diagnosed with CD within the preceding 3 months were prospectively enrolled at four tertiary centers. All patients recorded their symptoms on a website using a smartphone at least once a week. The index outcomes were disease-related admission and surgery during follow-up. The disease activity from enrollment to outcome or last follow-up was reviewed for pattern analysis. Cox regression analysis was used to identify the predictors of disease outcomes. A total of 102 patients were enrolled. During a median follow-up period of 42 months, 25 (24.5%) and 6 (5.9%) patients required admission and surgery, respectively. Poor activity pattern was an independent predictor of disease-related hospitalization (adjusted hazard ratio [aHR], 3.96; 95% confidence interval [CI] 1.5-10.45; p = 0.005). A poor activity pattern (aHR, 19.48; 95% CI 1.86-203.95; p = 0.013) and female sex (aHR, 11.28; 95% CI 1.49-85.01; p = 0.018) were found to be independent predictors of bowel resection. CD disease activity patterns monitored through the mobile monitoring system may help predict clinical outcomes, such as disease-related hospitalization and surgery, in patients with newly diagnosed CD.

Efficacy and safety of 1 L polyethylene glycol plus ascorbic acid for bowel preparation in elderly: comparison with oral sulfate solution.

BACKGROUND/AIMS: Recently, 1 L of polyethylene glycol (PEG) plus ascorbic acid (Asc) has been introduced in Korea as a colonoscopy preparation agent. Data on its efficacy and safety in older adults have been limited. We aimed to evaluate the safety and efficacy of 1 L PEG/Asc in older adults by comparing it with oral sulfate solution (OSS). METHODS: A prospective multicenter randomized study was conducted with subjects aged ≥ 65 years who underwent colonoscopy. The participants were randomized to receive 1 L PEG/Asc or OSS. The primary endpoint was successful bowel preparation, defined as total Boston Bowel Preparation Scale ≥ 6, and ≥ 2 at each segment. Patient satisfaction, adverse events, and renal function changes were compared between the groups. RESULTS: Among the 106 patients, 104 were finally included in the analysis. Overall, successful bowel preparation was achieved in 96.2% of both 1 L PEG/Asc and OSS groups. The satisfaction scores for taste, total amount ingested, overall feeling, and willingness to repeat the same regimen were not significantly different between the groups. Adverse events of moderate or higher severity occurred in 16 and 10 cases in the 1 L PEG/Asc and OSS group, respectively. There were no significant changes in electrolyte levels or renal function from baseline. CONCLUSION: The successful bowel preparation rate was > 90% in both groups without severe adverse effects and significant changes in renal function. As a new low-dose preparation regimen for colonoscopy in older adults, 1 L PEG/Asc, is as effective and safe as OSS.

Efficacy and Safety of Infliximab in Intestinal Behçet's Disease: A Multicenter, Phase 3 Study (BEGIN).

Background/Aims: To date, there is no prospective study that specifically investigated the efficacy of infliximab in intestinal Behçet's disease (BD). This study evaluated the efficacy of infliximab in patients with moderate-to-severe active intestinal BD that are refractory to conventional therapies. Methods: This phase 3, interventional, open-label, single-arm study evaluated clinical outcomes of infliximab treatment in patients with moderate-to-severe intestinal BD. The coprimary endpoints were clinical response, decrease in disease activity index for intestinal BD (DAIBD) score ≥20 from weeks 0 to 8 for the induction therapy and week 32 for the maintenance therapy. Results: A total of 33 patients entered the induction therapy and were treated with infliximab 5 mg/kg intravenously at weeks 0, 2, and 6. The mean DAIBD score changed from 90.8±40.1 at week 0 to 40.3±36.4 at week 8, with a significant mean change of 50.5±36.4 (95% confidence interval, 37.5 to 63.4; p<0.001). Thirty-one (93.9%) continued to receive 5 mg/kg infliximab every 8 weeks during the maintenance therapy. The mean change in the DAIBD score after the maintenance therapy was statistically significant (61.5±38.5; 95% confidence interval, 46.0 to 77.1; p<0.001, from weeks 0 to 32). The proportion of patients who maintained a clinical response was 92.3% at week 32. No severe adverse reactions occurred during the induction and maintenance therapies. Conclusions: This study provided evidence that infliximab 5 mg/kg induction and maintenance therapies are efficacious and well-tolerated in patients with moderate-to-severe active intestinal BD. (ClinicalTrials.gov identifier: NCT02505568).

Efficacy and safety of CKD-495 in acute and chronic gastritis: A Phase III superiority clinical trial.

BACKGROUND: Despite the availability of numerous treatment options, many patients with gastritis experience only partial symptom relief. CKD-495, a newly developed product with the active ingredient extracted from Cinnamomum cassia Presl., has demonstrated anti-inflammatory and antioxidant activity in vitro and an in vivo protective effect against gastric damage by stimulating mucus secretion. This study compared the efficacy and safety of CKD-495 with Artemisiae argyi folium (AAF) for the treatment of acute and chronic gastritis. AAF, a gastric mucosa protective agent that promotes gastric mucosa regeneration, has been used clinically for about 20 years. METHODS: This phase III multicenter, randomized, double-blind, parallel-group trial (ClinicalTrials.gov; NCT04255589) assigned 242 patients with endoscopically-proven gastric mucosal erosions to receive CKD-495 75 mg (n = 122) or AAF 60 mg (n = 120), respectively, with placebo (for double-blind purposes) 3 times a day for 2 weeks. The primary efficacy endpoint was the erosion improvement rate. Secondary endpoints included erosion cure rates, and improvement rates for edema, redness, hemorrhage, and gastrointestinal (GI) symptoms. Drug-related adverse events were evaluated. RESULTS: The erosion improvement rate was significantly higher in the CKD-495 group than in the AAF group for both the full analysis set (55.9% vs 39.4%, P = .0063) and per-protocol set (54.6% vs 38.2%, P = .0084). In addition, the erosion improvement rate in patients with acute or chronic gastritis showed that the CKD-495 group had better improvement of erosion than the AAF group, especially in patients with chronic gastritis. Analysis of secondary endpoints, which included erosion cure rate and the improvement rates of edema, redness, hemorrhage, and GI symptoms, showed that the CKD-495 group was more effective than the AAF group. There were no significant between-group differences in safety profiles. No serious adverse events or adverse drug reactions occurred. CONCLUSIONS: These results demonstrate that CKD-495 75 mg is superior to AAF 60 mg in terms of the endoscopic improvement rate of erosions in patients with acute or chronic gastritis. This new mucoprotective agent, CKD-495, can be considered the therapy of choice for symptomatic relief and healing of gastritis.