Comparison of the efficacy and tolerability of elobixibat plus sodium picosulfate with magnesium citrate and split-dose 2-L polyethylene glycol with ascorbic acid for bowel preparation before outpatient colonoscopy: a study protocol for the multicentre, randomised, controlled E-PLUS trial.

BACKGROUND: Sodium picosulfate (SP)/magnesium citrate (MC) and polyethylene glycol (PEG) plus ascorbic acid are recommended by Western guidelines as laxative solutions for bowel preparation. Clinically, SP/MC has a slower post-dose defaecation response than PEG and is perceived as less cleansing; therefore, it is not currently used for major bowel cancer screening preparation. The standard formulation for bowel preparation is PEG; however, a large dose is required, and it has a distinctive flavour that is considered unpleasant. SP/MC requires a small dose and ensures fluid intake because it is administered in another beverage. Therefore, clinical trials have shown that SP/MC is superior to PEG in terms of acceptability. We aim to compare the novel bowel cleansing method (test group) comprising SP/MC with elobixibat hydrate and the standard bowel cleansing method comprising PEG plus ascorbic acid (standard group) for patients preparing for outpatient colonoscopy. METHODS: This phase III, multicentre, single-blind, noninferiority, randomised, controlled, trial has not yet been completed. Patients aged 40-69 years will be included as participants. Patients with a history of abdominal or pelvic surgery, constipation, inflammatory bowel disease, or severe organ dysfunction will be excluded. The target number of research participants is 540 (standard group, 270 cases; test group, 270 cases). The primary endpoint is the degree of bowel cleansing (Boston Bowel Preparation Scale [BBPS] score ≥ 6). The secondary endpoints are patient acceptability, adverse events, polyp/adenoma detection rate, number of polyps/adenomas detected, degree of bowel cleansing according to the BBPS (BBPS score ≥ 8), degree of bowel cleansing according to the Aronchik scale, and bowel cleansing time. DISCUSSION: This trial aims to develop a "patient-first" colon cleansing regimen without the risk of inadequate bowel preparation by using both elobixibat hydrate and SP/MC. TRIAL REGISTRATION: Japan Registry of Clinical Trials (jRCT; no. s041210067; 9 September 2021; https://jrct.niph.go.jp/ ), protocol version 1.5 (May 1, 2023).

Impact of an artificial intelligence-aided endoscopic diagnosis system on improving endoscopy quality for trainees in colonoscopy: Prospective, randomized, multicenter study.

OBJECTIVE: This study was performed to evaluate whether the use of CAD EYE (Fujifilm, Tokyo, Japan) for colonoscopy improves colonoscopy quality in gastroenterology trainees. METHODS: The patients in this multicenter randomized controlled trial were divided into Group A (observation using CAD EYE) and Group B (standard observation). Six trainees performed colonoscopies using a back-to-back method in pairs with gastroenterology experts. The primary end-point was the trainees' adenoma detection rate (ADR), and the secondary end-points were the trainees' adenoma miss rate (AMR) and Assessment of Competency in Endoscopy (ACE) tool scores. Each trainee's learning curve was evaluated using a cumulative sum (CUSUM) control chart. RESULTS: We analyzed data for 231 patients (Group A, n = 113; Group B, n = 118). The ADR was not significantly different between the two groups. Group A had a significantly lower AMR (25.6% vs. 38.6%, P = 0.033) and number of missed adenomas per patient (0.5 vs. 0.9, P = 0.004) than Group B. Group A also had significantly higher ACE tool scores for pathology identification (2.26 vs. 2.07, P = 0.030) and interpretation and identification of pathology location (2.18 vs. 2.00, P = 0.038). For the CUSUM learning curve, Group A showed a trend toward a lower number of cases of missed multiple adenomas by the six trainees. CONCLUSION: CAD EYE did not improve ADR but decreased the AMR and improved the ability to accurately locate and identify colorectal adenomas. CAD EYE can be assumed to be beneficial for improving colonoscopy quality in gastroenterology trainees. TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry (UMIN000044031).

Estimating colorectal polyp size with a virtual scale endoscope and visual estimation during colonoscopy: Prospective, preliminary comparison of accuracy.

The virtual scale endoscope (VSE) is a new endoscope that helps estimate the size of neoplasms in the gastrointestinal tract. We compared the accuracy of polyp size estimation by VSE with that of visual estimation. A dual center prospective study was conducted in two Japanese academic endoscopy units. Ten endoscopists (five trainees and five experts) estimated the size of 20 simulated polyps in four colon phantoms during colonoscopy by two methods: conventional visual estimation and estimation by VSE. The primary endpoint was the relative accuracy in relation to true polyp size according to visual estimation and VSE estimation during colonoscopy. The secondary endpoint was the required time (the time needed to measure in each procedure). The mean values of the primary end-point were 62.5% for visual estimation and 84.0% for VSE estimation; hence the result differed significantly (95% confidence interval 18.3-24.7; P < 0.001). The mean of required times was significantly longer for estimation by VSE (6.4 min) than that by visual estimation (2.9 min; P < 0.001). The accuracy of colorectal polyp size estimation was superior with VSE than with visual estimation during colonoscopy. In the future, VSE should be evaluated in actual clinical settings, including the time required for size estimation.

Collagenous Colitis Possibly Associated with Dipeptidyl Peptidase-4 Inhibitor.

A 60-year-old man with type 2 diabetes mellitus treated with a dipeptidyl peptidase-4 (DPP-4) inhibitor was referred to our hospital because of his refractory watery diarrhea. Ileocolonoscopy revealed increased capillary growth, fine granular mucosa, and longitudinal mucosal tears mainly in the left side of the colon. A bioptic examination revealed thickened subepithelial collagen bands, thus confirming the diagnosis of collagenous colitis. Systemic steroid therapy was initiated, but his symptoms recurred when tapering the steroid. However, withdrawal of the DPP-4 inhibitor was successful even after the cessation of steroid therapy. We therefore considered his collagenous colitis to have been caused by the DPP-4 inhibitor.