Naoki Ohmiya

OBJECTIVES: We aimed to determine the compliance, safety, and acceptance of colon capsule endoscopy (CCE) and small bowel capsule endoscopy (SBCE) in an out-of-clinic setting remotely supported by medical staff. METHODS: We enrolled 30 examinees (24 with CCE and six with SBCE) who had not undergone CE at six gastroenterological centers. All examinees were provided with instructions on equipment and bowel preparations. RESULTS: CCE was performed at home (n = 16) or at the workplace (n = 8). Compliance with data-recorder alerts was 100% for bowel preparation and 79% for equipment operation. Total capsule colonoscopy was achieved in 83.3%. The overall adequate endoscopic cleansing rate was 83.3%, and abnormalities, including colorectal polyps, were detected in 37.5%. CCE malfunction, such as the inability to automatically detect the small bowel mucosa occurred in one (4.2%). One experienced mild abdominal pain that required no treatment. Inquiries were present from half of the examinees. The proportions of examinees who desired and refused CCE at the next examination were 67% and 4%, respectively. SBCE was performed at home (n = 4) or at the workplace (n = 2). Compliance with the procedures was 100%. Whole small bowel images were recorded for all examinees. The overall adequate endoscopic clearness rate was 100%. One abnormality was detected. Inquiries were present from half of the examinees. There were no adverse events or malfunctions. The proportion of examinees who reported "quite easy" and "fairly easy" was 66%. CONCLUSION: CCE and SBCE with all procedures in the out-of-clinic setting supported by remote consultations were feasible. A multicenter prospective study of the safety and acceptance of capsule endoscopy examinations at home (HomeCam-J study) (jRCTs042220163).

BACKGROUND: A serum biomarker for diagnosing ulcerative colitis (UC) remains to be established. Although we recently reported an anti-integrin αvβ6 antibody (V6 Ab) for diagnosing UC with high sensitivity and specificity, no large-scale validation study exists. This study aimed to validate the diagnostic value of V6 Ab for UC using a nationwide multicenter cohort study. METHODS: We measured V6 Ab titers in patients definitively diagnosed with UC, Crohn's disease (CD), or other gastrointestinal disorders (OGDs). The primary outcome was the diagnostic value of V6 Ab. Secondary outcomes were factors associated with false-negative results in patients with UC and false-positive results in patients without UC and the heterogeneity of the diagnostic value of V6 Ab among the participating facilities. RESULTS: We enrolled 1241, 796, and 206 patients with UC, CD, and OGD, respectively, from 28 Japanese high-volume referral centers. The diagnostic sensitivity of V6 Ab for UC was 87.7%, and its specificities for CD and OGDs were 82.0% and 87.4%, respectively. Multivariable logistic regression analysis showed that false-negative results were associated with older age at the time of sample collection, current smokers, lower partial Mayo score, and not receiving advanced therapies in patients with UC, and false-positive results were associated with colonic CD in patients with CD. No factor was associated with false-positive results in patients with OGDs. There were no significant differences in the diagnostic value of V6 Ab among the centers. CONCLUSIONS: The diagnostic value of V6 Ab for UC was validated in the large-scale nationwide multicenter study.

BACKGROUND & AIMS: Although biologic therapy has revolutionized the treatment of Crohn's disease (CD), surgery remains unavoidable in cases involving ileal complications. We aimed to evaluate the efficacy of biologics on proximal ileal lesions using balloon-assisted enteroscopy (BAE). METHODS: This open-label multicenter prospective study was conducted at tertiary referral centers in Japan. We enrolled 253 patients with active ileal CD who were treated with biologics (infliximab/adalimumab/ustekinumab/vedolizumab). BAE was performed at week 0 and week 26, and endoscopic findings were centrally assessed. We evaluated the rate of endoscopic remission (defined as having a maximum modified Simple Endoscopic Score for Crohn's disease <4) at week 26 and patient prognosis (CD-related hospitalization and surgery). RESULTS: At baseline, 74 patients (29.2%) had proximal ileal ulcerations without terminal ileal ulcerations. The second BAE showed that endoscopic remission was achieved in 91 patients (36.0%). Of the patients with complete ulcer healing of the terminal ileum, 28.6% (22/77) had residual ulcers in the proximal ileum. The rate of endoscopic remission in the proximal ileum (50.9%) was relatively lower compared with the colon (63.4%) and terminal ileum (56.7%), a trend consistently observed across all treatment agents. After a median follow-up of 134 weeks, residual ulcerations in the proximal ileum were associated with a poorer prognosis (P = .0126 for hospitalization and P = .0014 for surgery). CONCLUSIONS: A substantial proportion of patients with CD exhibited ulcerations in the proximal ileum, which correlated with a poorer prognosis. These lesions proved challenging to heal, regardless of the type of biologic used.

BACKGROUND AND AIMS: We determined the factors influencing total capsule colonoscopy, adequate cleansing, and detectability of second-generation colon capsule endoscopy (CCE) for colorectal polyps or tumors (CRTs), adverse events, and acceptability. METHODS: Among 44 Japanese hospitals, 1,006 patients with suspected or documented colorectal diseases who underwent CCE were enrolled prospectively. RESULTS: The total capsule colonoscopy rate was 86.1%. Age younger than 63 years (adjusted odds ratio [aOR], 1.525), male sex (aOR, 1.496), inflammatory bowel disease (aOR, 1.889), lavage intake on Day -1 (aOR, 1.625), ≥1800 mL lavage intake on Day 0 (aOR, 0.595), prokinetics on Day 0 (aOR, 0.608), and ≥30 mL castor oil booster on Day 0 (aOR, 1.734) were significant independent predictors. The overall adequate cleansing rate was 65.5%. Constipation (aOR, 0.527), lavage intake on Day -1 (aOR, 1.822), laxative intake on Day -1 (aOR, 2.616), and ≥1900 mL lavage intake on Day 0 (aOR, 1.449) were significant independent predictors. The detection rates (95% confidence intervals) for patients with CRTs ≥6 mm and ≥10 mm were 92 (84-97) % and 89 (78-96) %, respectively. Inadequate cleansing in the ascending colon (aOR, 0.184), ≥6 mm CRT in the transverse colon (aOR, 4.703), and ≥6 mm CRT in the left-sided colon (aOR, 32.013) were significant independent predictors. CCE retention occurred in two patients (0.20%) requiring endoscopic and surgical interventions. In total, 63% of patients desired CCE for their next colonoscopy. CONCLUSIONS: CCE was relatively safe, well tolerated, and useful for detecting colorectal lesions when adequate bowel preparation was made.