Introduction

Sodium picosulfate (SP)/magnesium citrate (MC) and polyethylene glycol (PEG) plus ascorbic acid are recommended by Western guidelines as laxative solutions for bowel preparation. The standard formulation for bowel preparation is PEG; however, it requires a large dose and has a distinctive taste that is considered unpleasant. SP/MC requires a small dose and ensures fluid intake because it is administered in another beverage. Therefore, clinical studies have shown that SP/MC is superior to PEG in terms of acceptability.

Aims & Methods

Our aim was to compare the novel bowel cleansing method (test group) consisting of SP/MC with elobixibat hydrate and the standard bowel cleansing method consisting of PEG plus ascorbic acid (standard group) in patients preparing for outpatient colonoscopy. This was a multicenter, single-blind, non-inferiority, randomized controlled trial. Patients 40-69 years of age scheduled for outpatient colonoscopy were enrolled. Patients with a history of abdominal or pelvic surgery, constipation, inflammatory bowel disease, or severe organ dysfunction were excluded. The target number of study participants was 540 (standard group, 270 cases; test group, 270 cases). The primary endpoint was bowel cleansing (Boston Bowel Preparation Scale [BBPS] score ≥6). Secondary endpoints were patient acceptability, adverse events, polyp/adenoma detection rate, number of polyps/adenomas detected, degree of bowel cleansing according to BBPS (BBPS score ≥8), degree of bowel cleansing according to Aronchik scale, and bowel cleansing time. The non-inferiority margin for the primary endpoint was 10%. A study protocol of the present study has already been published in a peer-reviewed journal.

Results

Of 540 participants enrolled, efficacy was analyzed in 524 participants (test group, n=263; standard group, n=261) in the full analysis set. Non-inferiority of the test group was demonstrated for the primary endpoint (BBPS ≥6): 96.2% vs. 97.7% for test and standard group, respectively difference was -1.5%, [95%confidence interval (CI), -4.8 to 1.6%] with P<0.001 for non-inferiority. For the secondary endpoint BBPS≥8 was lower in test group (79.5% vs 91.2%: difference -11.7% [95% CI, -17.8 to -5.8%]). Patient acceptability was superior in the test group in the key questions (1. Was the bowel preparation medication easy to use? 2. Were all bowel preparation medications administered internally? 3. What is your overall impression of the bowel preparation? 4. How did the bowel preparation medicine taste? 5. Would you like to use the same bowel preparation medicine for your next colonoscopy?) Adverse events were similar in both groups.

Conclusion

A new regimen of elobixibat plus sodium picosulfate with magnesium citrate was non-inferior in bowel cleansing and superior in patient’s acceptability compared to split-dose 2-L polyethylene glycol with ascorbic acid.

References

1) Hotta K, Otake Y, Yamaguchi D, et al. 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. BMC Gastroenterol 2024 Feb 3;24(1):61.doi: 10.1186/s12876-024-03146-6.

Disclosure

The primary investigator (Kinichi Hotta) had received research funding from Nippon Chemiphar Co. Ltd.

Introduction

Non-expert endoscopists’ optical diagnosis (OD) of colorectal polyps falls short of ‘resect and discard’ and ‘diagnose and leave’ thresholds. Previous CADx studies are limited to locally deployed hardware AI systems and are mainly evaluated in expert endoscopists. CADDIE is a cloud-based CADx system that receives the live image stream from the endoscopy screen via the hospital’s internet network, where the AI algorithm processes the images and outputs its diagnosis (adenoma, non-adenoma or uncertain) on the endoscopy screen.

We aimed to assess the performance of the real-time cloud-based CADDIE system when colonoscopy is undertaken by non-expert endoscopists (adenoma detection rate below 30%).

Aims & Methods

We enrolled 739 patients between April 2021 - Dec 2022, scoped by 32 endoscopists in 9 UK hospitals. Each endoscopist was limited to a maximum of 60 procedures and required to perform more than 20% of this target. Patients were block randomised in a 1:1 ratio to standard of care (SOC) or intervention (CADDIE), stratified by endoscopist and indication. OD accuracy of humans alone (SOC arm) and humans aided by CADDIE (CADDIE arm) were compared to the CADDIE system’s stand-alone performance in the CADDIE arm.

Results

There were 615 evaluable patients after exclusions as pre-defined in the study protocol. There were 523 eligible polyps (270 SOC arm, 253 CADDIE arm). The CADDIE system diagnosed 17.8% of polyps (45/253) as “uncertain”.

Human alone (SOC) OD accuracy was 75.9%, human OD aided by CADDIE was 80.2%, whilst the stand-alone CADDIE system was significantly higher than both at 87.5% (p=0.005 and p=0.04, respectively). Similarly, in the sub-analysis of small/diminutive polyps (≤10mm), human alone OD accuracy was 73.8%, human OD aided by CADDIE was 79.0%, whilst the CADDIE system was significantly higher than both at 87.9% (p=0.001 and p=0.02). Although results were not significant for diminutive polyps (≤5mm), the trend was towards higher accuracy in the CADDIE system (86.6%) compared to humans alone and human OD aided by CADDIE (77.3%;p=0.05).

In sub-analyses of high-confidence (HC) OD, the CADDIE system’s accuracy for ≤10mm polyps was significantly higher (87.9%) than humans alone (78.4%;p=0.04), with no difference to humans aided by CADDIE (83.3%;p=0.18). For HC OD of ≤5mm polyps, where the sample size is smaller, the CADDIE system’s accuracy was higher (86.6%) but not significant compared to humans alone (82.7%,p=0.46) and humans aided by CADDIE (81.4%,p=0.28).

The OD-derived colonoscopy surveillance interval accuracy was 87.2% in humans alone (SOC), 86.8% in humans aided by CADDIE and 90.9% for the CADDIE system.

Conclusion

We demonstrate proof of concept and robust results for a cloud-based CADx system. Further research is warranted in the human-computer interaction to optimise non-expert endoscopists’ OD performance to that of CADx systems.

Disclosure

Dr Rawen Kader and Professor Laurence Lovat have received medical consultancy fees from Odin Vision