Impact of Artificial Intelligence on Colonoscopy Surveillance After Polyp Removal: A Pooled Analysis of Randomized Trials.

BACKGROUND AND AIMS: Artificial intelligence (AI) tools aimed at improving polyp detection have been shown to increase the adenoma detection rate during colonoscopy. However, it is unknown how increased polyp detection rates by AI affect the burden of patient surveillance after polyp removal. METHODS: We conducted a pooled analysis of 9 randomized controlled trials (5 in China, 2 in Italy, 1 in Japan, and 1 in the United States) comparing colonoscopy with or without AI detection aids. The primary outcome was the proportion of patients recommended to undergo intensive surveillance (ie, 3-year interval). We analyzed intervals for AI and non-AI colonoscopies for the U.S. and European recommendations separately. We estimated proportions by calculating relative risks using the Mantel-Haenszel method. RESULTS: A total of 5796 patients (51% male, mean 53 years of age) were included; 2894 underwent AI-assisted colonoscopy and 2902 non-AI colonoscopy. When following U.S. guidelines, the proportion of patients recommended intensive surveillance increased from 8.4% (95% CI, 7.4%-9.5%) in the non-AI group to 11.3% (95% CI, 10.2%-12.6%) in the AI group (absolute difference, 2.9% [95% CI, 1.4%-4.4%]; risk ratio, 1.35 [95% CI, 1.16-1.57]). When following European guidelines, it increased from 6.1% (95% CI, 5.3%-7.0%) to 7.4% (95% CI, 6.5%-8.4%) (absolute difference, 1.3% [95% CI, 0.01%-2.6%]; risk ratio, 1.22 [95% CI, 1.01-1.47]). CONCLUSIONS: The use of AI during colonoscopy increased the proportion of patients requiring intensive colonoscopy surveillance by approximately 35% in the United States and 20% in Europe (absolute increases of 2.9% and 1.3%, respectively). While this may contribute to improved cancer prevention, it significantly adds patient burden and healthcare costs.

Reducing adenoma miss rate of colonoscopy assisted by artificial intelligence: a multicenter randomized controlled trial.

BACKGROUND: We have developed the computer-aided detection (CADe) system using an original deep learning algorithm based on a convolutional neural network for assisting endoscopists in detecting colorectal lesions during colonoscopy. The aim of this study was to clarify whether adenoma miss rate (AMR) could be reduced with CADe assistance during screening and surveillance colonoscopy. METHODS: This study was a multicenter randomized controlled trial. Patients aged 40 to 80 years who were referred for colorectal screening or surveillance at four sites in Japan were randomly assigned at a 1:1 ratio to either the "standard colonoscopy (SC)-first group" or the "CADe-first group" to undergo a back-to-back tandem procedure. Tandem colonoscopies were performed on the same day for each participant by the same endoscopist in a preassigned order. All polyps detected in each pass were histopathologically diagnosed after biopsy or resection. RESULTS: A total of 358 patients were enrolled and 179 patients were assigned to the SC-first group or CADe-first group. The AMR of the CADe-first group was significantly lower than that of the SC-first group (13.8% vs. 36.7%, P < 0.0001). Similar results were observed for the polyp miss rate (14.2% vs. 40.6%, P < 0.0001) and sessile serrated lesion miss rate (13.0% vs. 38.5%, P = 0.03). The adenoma detection rate of CADe-assisted colonoscopy was 64.5%, which was significantly higher than that of standard colonoscopy (53.6%; P = 0.036). CONCLUSION: Our study results first showed a reduction in the AMR when assisting with CADe based on deep learning in a multicenter randomized controlled trial.

[A case of Crohn's disease complicated by Guillain-Barrè syndrome during ustekinumab therapy].

We herein report a case involving a 23-year-old male patient with active Crohn's disease complicated by Guillain-Barrè syndrome during ustekinumab therapy. At age 11, the patient developed an anal fistula and was found to have multiple aphthae on the rectosigmoid colon, for which he was diagnosed with Crohn's disease. At age 12, he underwent gastrojejunal anastomosis for pyrolic stenosis. At age 20, a longitudinal ulcer was found on the ascending colon, and at age 21, aphthae were found on the stomach and efferent jejunum. At age 22, adalimumab was started, but the patient noted abdominal pain and diarrhea 4 months later. Hence, adalimumab was switched to ustekinumab (2017 June). Though ustekinumab was effective, the patient noted anorexia, weakness, and bilateral lower extremity numbness 1 year later (2018 June) and was admitted to the hospital. He was then diagnosed with Guillain-Barrè syndrome after spinal tap, neurological, and hematological examinations. Immunoglobulin therapy was provided but was less effective. The patient has since been receiving physical therapy. This has been the first report regarding Guillain-Barrè syndrome as a complication during ustekinumab therapy.

Comparison of efficacies of once-daily dose multimatrix mesalazine and multiple-dose mesalazine for the maintenance of remission in ulcerative colitis: a randomized, double-blind study.

BACKGROUND/AIMS: This study compared the efficacy of once-daily administration of multimatrix mesalazine 2.4 g/day with multiple-dose mesalazine for the maintenance of remission. METHODS: In this multicenter, randomized, double-blind study, 203 patients with ulcerative colitis in remission received multimatrix mesalazine 2.4 g/day once-daily or time-dependent (controlled-release) mesalazine 2.25 g/day 3 times-daily for 48 weeks. The primary efficacy endpoint was the proportion of patients without rectal bleeding. RESULTS: The proportion of patients without rectal bleeding during the 48-week treatment period in the per protocol set was 84.8% (84/99) in the multimatrix mesalazine 2.4 g/day group and 78.0% (78/100) in the controlled-release mesalazine 2.25 g/day group. The difference between the 2 treatment groups was 6.8% (two-sided 95% confidence interval, -3.9% to 17.6%). The noninferiority margin of -10% was met in the comparison of multimatrix mesalazine 2.4 g/day once-daily with controlled-release mesalazine 2.25 g/day. Multimatrix mesalazine 2.4 g/day once-daily demonstrated consistent efficacy in all subgroups. There was no difference between the 2 treatment groups with regard to safety. CONCLUSIONS: A once-daily dose of 2 multimatrix mesalazine tablets (2.4 g) was not inferior to controlled-release mesalazine 2.25 g/day 3 times-daily in maintaining absence of rectal bleeding in ulcerative colitis.

2.4 g Mesalamine (Asacol 400 mg tablet) Once Daily is as Effective as Three Times Daily in Maintenance of Remission in Ulcerative Colitis: A Randomized, Noninferiority, Multi-center Trial.

BACKGROUND: The noninferiority of pH-dependent release mesalamine (Asacol) once daily (QD) to 3 times daily (TID) administration was investigated. METHODS: This was a phase 3, multicenter, randomized, double-blind, parallel-group, active-control study, with dynamic and stochastic allocation using central registration. Patients with ulcerative colitis in remission (a bloody stool score of 0, and an ulcerative colitis disease activity index of ≤2), received the study drug (Asacol 2.4 g/d) for 48 weeks. The primary efficacy endpoint of the nonrecurrence rate was assessed on the full analysis set. The noninferiority margin was 10%. RESULTS: Six hundred and four subjects were eligible and were allocated; 603 subjects received the study drug. The full analysis set comprised 602 subjects (QD: 301, TID: 301). Nonrecurrence rates were 88.4% in the QD and 89.6% in the TID. The difference between nonrecurrence rates was -1.3% (95% confidence interval: -6.2, 3.7), confirming noninferiority. No differences in the safety profile were observed between the two treatment groups. On post hoc analysis by integrating the QD and the TID, nonrecurrence rate with a mucosal appearance score of 0 at determination of eligibility was significantly higher than the score of 1. The mean compliance rates were 97.7% in the QD and 98.1% in the TID. CONCLUSIONS: QD dosing with Asacol is as effective and safe as TID for maintenance of remission in patients with ulcerative colitis. Additionally, this study indicated that maintaining a good mucosal state is the key for longer maintenance of remission.

Factors associated with poor therapeutic response in outpatients with irritable bowel syndrome: a multicenter study in Japan.

BACKGROUND: Some patients with irritable bowel syndrome (IBS) show poor response to treatment. However, risk factors associated with poor therapeutic response have not been determined. METHODS: This multicenter trial evaluated consecutive outpatients with IBS undergoing treatment for more than 1 month. Mental health status and physical function were evaluated using the Japanese version of the SF-8. Therapeutic response was evaluated using the IBS severity index-Japanese version (IBS-SIJ). Patients with IBS-SIJ scores ≥175 were defined as poor responders to treatment, whereas those with IBS-SIJ scores <175 were defined as good responders. The demographic and clinical characteristics of these two groups, along with medications, were compared. RESULTS: The study enrolled 131 participants, 75 with IBS-SIJ scores ≥175-56 with IBS-SIJ scores <175. Multiple logistic regression analysis showed that female sex [odds ratio (OR) 2.67, 95 % confidence interval (CI) 1.19-5.97, p = 0.0167] and mental component summary (MCS) of the SF-8 <40 (OR 2.58, 95 % CI 1.12-5.97, p = 0.0263) were independent risk factors for poor therapeutic response in patients with IBS. CONCLUSIONS: Lower MCS and female sex were risk factors for poor therapeutic response in patients with IBS. Ascertaining the mechanisms by which lower MCS and female sex are associated with poor therapeutic response in IBS may help design better treatments (Trial registration number: UMIN000016804).

Prospective, randomized, placebo-controlled trial evaluating the efficacy and safety of propofol sedation by anesthesiologists and gastroenterologist-led teams using computer-assisted personalized sedation during upper and lower gastrointestinal endoscopy.

BACKGROUND AND AIM: No randomized controlled studies comparing propofol versus no sedation have been reported. Comparative data demonstrating the efficacy and safety of propofol sedation by anesthesiologists (ANES), and gastroenterologist-led teams (GLT) using computer-assisted personalized sedation (CAPS), during routine gastrointestinal (GI) endoscopy in Japan do not exist. We aimed to demonstrate the safety and efficacy of propofol sedation versus no sedation (PLCB) when propofol is given by ANES or GLT, during routine GI endoscopy. METHODS: Two hundred and seventy two American Society of Anesthesiologists (ASA) class I or II adults were prospectively enrolled in this multicenter study and randomized into three groups (PLCB, ANES, GLT). Ability to maintain moderate sedation, defined as MOAA/S scores of 2-4 for ≥50% of all MOAA/S measurements from scope-in to scope-out, was the primary endpoint. Secondary endpoints included patient (PSSI) and clinician (CSSI) satisfaction. RESULTS: Proportion of subjects maintained in moderate sedation by ANES (88.1%) and GLT (94.5%) was significantly higher than PLCB (21.6%; P < 0.001); there was no difference between the ANES and GLT groups (P = 0.116). Mean PSSI scores for subjects sedated by ANES (81.2 ± 12.5) and GLT (80.8 ± 14.1) were significantly higher than PLCB (65.3 ± 19.7; P < 0.001) and mean CSSI scores were also significantly higher in both active treatment groups (75.5 ± 10.2, 77.9 ± 10.3) than PLCB (60.8 ± 18.6; P < 0.001). CONCLUSION: Moderate sedation can be achieved and maintained with propofol, improving both patient and physician satisfaction, when propofol is given by an anesthesiologist or a gastroenterologist-led team using CAPS.

Twice-daily Budesonide 2-mg Foam Induces Complete Mucosal Healing in Patients with Distal Ulcerative Colitis.

BACKGROUND AND AIMS: Mucosal healing is an important therapeutic goal for ulcerative colitis. Once-daily administration of budesonide 2-mg foam is widely used for inducing clinical remission. No study has assessed the usefulness of twice-daily budesonide 2mg foam on mucosal healing in ulcerative colitis patients. We explored the efficacy for mucosal healing of once- or twice-daily budesonide foam in distal ulcerative colitis patients. METHODS: This study was a multicentre, randomised, double-blind, placebo-controlled trial. In all, 165 patients with active, mild to moderate distal ulcerative colitis were randomised to three groups: once- or twice-daily budesonide 2mg/25ml foam, or placebo foam, for 6 weeks. Complete mucosal healing [endoscopic subscore = 0] and the safety profile were assessed at Week 6. Prespecified and post hoc analyses were used. RESULTS: The percentages of complete mucosal healing in the twice-daily budesonide foam group were 46.4% compared with 23.6% in the once-daily group [p = 0.0097], or 5.6% in the placebo group [p < 0.0001]. The percentages of clinical remission and the percentages of endoscopic subscore ≤ 1 in the twice-daily budesonide foam group were 48.2% and 76.8%, compared with 50.9% and 69.1% in the once-daily group [no difference], or 20.4% and 46.3% in the placebo group [p = 0.0029 and p = 0.0007], respectively. In the subgroup of patients with previous use of a 5-aminosalicylic acid suppository or enema, there was a greater percentage of complete mucosal healing in the twice-daily budesonide foam group [32.0%] compared with that in the once-daily [8.7%, p = 0.0774] or placebo groups [4.8%, p = 0.0763], though there was no significant difference. No serious adverse event occurred. CONCLUSIONS: A significantly greater percentage of patients receiving twice-daily administration of budesonide foam compared with once-daily administration/placebo achieved complete mucosal healing. This is the first study to evaluate the endoscopic efficacy of twice-daily administration of 6-week budesonide foam treatment for ulcerative colitis.

Comparison of QD and TID oral mesalazine for maintenance of remission in quiescent ulcerative colitis: a double-blind, double-dummy, randomized multicenter study.

BACKGROUND: Mesalazine preparations are widely used to treat mild to moderately severe ulcerative colitis (UC). We compared once-daily administration of oral mesalazine in patients with quiescent UC with the established 3-times-daily prescription, assessing the efficacy and safety of each method in maintaining remission for 52 weeks. METHODS: This was a double-blind, double-dummy, randomized, multicenter noninferiority study in which 301 patients with quiescent UC were randomly assigned to treatment groups and administered prolonged-release oral mesalazine at doses of 1.5 to 2.25 g/d once daily (QD) or 3 times daily (TID) for 52 weeks. The primary endpoint was whether remission was maintained after 52 weeks of administration or until the time of discontinuation, as represented by the Ulcerative Colitis Disease Activity Index score. RESULTS: The proportion of patients still in remission after 52 weeks of administration was 79.4% in the QD group and 71.6% in the TID group. The between-group difference was 7.8% (2-tailed 95% confidence interval [CI]: -2.2% to 17.8%), and the noninferiority of QD administration to TID administration was verified with a noninferiority margin of -10%. In the safety analysis, the incidence of adverse events in each group was 72.4% for the QD group and 76.5% for the TID group, showing no statistically significant difference between the 2 groups (P = 0.4305). CONCLUSIONS: This double-blind parallel-group comparison verified for the first time the noninferiority of QD administration of oral mesalazine 1.5 to 2.25 g/d to TID administration in terms of maintaining remission in patients with UC.