Introduction

Significant advances have been made in identifying biomarkers to predict IBD onset. With the use of predictive testing to identify individuals at risk of developing the disease, it would be possible to intervene and try to mitigate that risk. However, the feasibility of such strategy would depend on whether individuals at risk of developing IBD would be willing to undergo predictive testing and preventive interventions.

Aims & Methods

An anonymized electronic survey was created in eight different languages and disseminated by clinicians and patient’s associations; patients with IBD, patients with an at-risk first-degree relative (offspring), and their first-degree relatives were invited to provide their feedback. The survey had four main sections – participants’ characterization, knowledge of disease, predictive tests and preventive interventions. Univariate and multivariate logistic regression were used to assess factors associated to acceptance of predictive testing and preventive interventions.

Results

Overall, 2034 participants (73% women, mean age of 43±13 years old) from 66 different countries (80% from Europe), participated. Most participants (52%) were parents with IBD with healthy at-risk children. 51% of individuals with IBD had Crohn’s disease, 56% were undergoing treatment with biologics, 28% had a history of surgery, and 61% reported a significant impact on their quality of life caused by disease. 73% recognized IBD as a disease with no defined genetic transmission, but with an increased risk among FDR of affected patients. Most participants (82%) would be willing to undergo, predictive testing, or to have their children undergo them, mainly with minimally-invasive blood (91%), stool (90%) or saliva tests (78%), or intestinal ultrasound (68%); 46% would accept a colonoscopy. The main benefits recognized with predictive testing were the possibility of starting preventive interventions to minimize the risk of developing IBD (69%) and to obtain an earlier diagnosis (58%). The main disadvantage was anxiety generated from a positive result (57%). Overall, 97% of participants were willing to accept preventive interventions. The most accepted were dietary modification (82%), physical exercise (79%) and probiotics (71%). Overall, 40% and 34% would accept oral or intravenous/subcutaneous immunosuppressive treatment, respectively; provided that the risk of minor adverse events was negligible to acceptable (23%), while 44% considered that the risk of major adverse events should be <1% to be acceptable. In multivariate analysis, factors associated with less acceptance of predictive testing were older age (p<0.001) and treatment with thiopurine (p<0.001). Factors only associated with less acceptance of preventive interventions were having ulcerative colitis (p=0.004) or undetermined colitis (p<0.001) and being treated with mesalazine (p<0.001). Having a disease with low impact in their/their family members’ quality of life were associated with less acceptance of both predictive testing and preventive interventions (p<0.001).

Conclusion

The vast majority of parents with children at-risk for IBD, or first-degree relatives at risk for IBD development would accept minimally-invasive predictive testing for IBD. The vast majority expressed acceptance of non-pharmacological interventions, however, more than one-third would be willing to accept immunosuppressive medications, particularly if associated with a low risk of minor and major adverse events. This data provides useful and important information for the development of prediction and prevention strategies.

Introduction

Aspiration Pneumonia is a well described complication of upper digestive endoscopy. However, limited data are available on incidence, risk factors and clinical consequences of post- Endoscopic retrograde cholangiopancreatography (ERCP) aspiration pneumonia (pEP).

Aims & Methods

All consecutive ERCPs performed under anesthesiologist-administered sedation at the Endoscopy Unit of the University of Verona between April 1st 2022 and August 31st 2024 were retrospectively evaluated. Demographical, clinical and endoscopic data were collected.

Results

One-thousand-one-hundred-forty consecutive ERCPs were included. Main indication was malignant biliary stricture and patient’s mean age was 68±13.9 years. Overall incidence of pEP was 2.7%. American Society of Anesthesiologists (ASA) score, presence of active cholangitis before ERCP and performance of endoscopic ultrasound (EUS) and ERCP in the same sedation session were significantly associated to higher risk of pEP at both univariable and multivariable analysis. pEP was an independent risk factor for post-ERCP 30-days-mortality and for prolonged hospital stay.

Conclusion

pEP is a relatively frequent adverse event after ERCP. In patent with high ASA score, active cholangitis and scheduled EUS and ERCP in the same sedation session, preventive medical and/or anesthesiological strategies might be considered. Additional prospective studies are needed to confirm these data.

References

Incidence rates of post-ERCP complications: a systematic survey of prospective studies. Complications of ERCP: a prospective study.
ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline.
Unrecognised aspiration pneumonitis during enteroscopy: two case report.
Efficecay and safety of therapeutic endoscopic retrograde cholangiopancreatography in patients with native papillae with a performance status score of 3 or 4: a single-center retrospective study.
A prospective assessment of sedation-related adverse events and patient and endoscopist satisfaction in ERCP with anesthesiologist-administred sedation.
Increased ERCP-related adverse event from premature urgent ERCP following symptom onset in acute biliary pancreatitis with cholangitis.
Acute sedation-associated complications in GI endoscopy (ProSed 2 Study): results from the prospective multicentre electronic registry of sedation-associated complications.
Deep sedation without intubation for ERCP is appropriate in healthier, non-obese patients.
Comparative efficacy and safety of anesthetic and sedative regimens for endoscopic retrograde cholangiopancreatography: a network meta-analysis.
International consensus recommendations for difficult biliary access.
Intraprocedural quality in endosocpic retrograde cholangiopancreatography: e meta-analysis.
Criteria for difficult biliary cannulation: start to count.
Safety and efficacy of therapeutic endoscopic retrograde cholangiopancreatography for patients over 90 years of age.
Risk factors for post-endoscopic retrograde cholangiopancreatography complications in very elderly patients aged 90 years or older-no additional risk.

Disclosure

I have no conflict of interest

Introduction

Colon Capsule Endoscopy (CCE) offers a non-invasive alternative to colonoscopy for lower gastrointestinal (GI) investigations. However, its adoption is limited by lengthy reading times, reader fatigue, and variable diagnostic accuracy. These factors are often influenced by bowel preparation quality and completion rates. Artificial intelligence (AI) has shown the potential to improve diagnostic accuracy of polyp detection and reduce reading times in capsule endoscopy.

Aims & Methods

Objective(s): The primary aim is to assess the diagnostic accuracy of Computer-Aided Detection (CADe) system (AiSPEED™) assisted CCE reading using full-video analysis in a real-world clinical setting. Secondary outcome was to assess a) non-inferiority compared to standard clinician reading in detecting polypoid lesions and b) mean reading time.
Methods: CESCAIL study is a multi-centre study of 14 UK centres recruited 720 participants between November 2021 and September 2024. Participants (prospectively and retrospectively enrolled ) included those ≥18 years referred for CCE under the urgent cancer pathway or for post-polypectomy surveillance. CCEs were performed using PillCam™ COLON 2 and analysed using AiSPEED™. CCE videos were evaluated by separate clinicians who provided standard readings, while AI-assisted reading included an AI-assisted pre-reader review and subsequent clinician validation.

Results

720 patients were enrolled, with 673 included in the final analysis. The capsule excretion rate before battery depletion was 77.1%, with adequate bowel preparation achieved at 78.1% (with standard) and 74.0% (with AI-assisted reading) (McNemar p=0.108). In the per-patient analysis, the diagnostic yield for detecting polyps was 63.6% (428/673) for standard reading and 70.6% (475/673) for AI-assisted reading, using the expert panel as the reference standard. These findings confirmed both non-inferiority (p<0.001) and superiority (p<0.001) of the AI-assisted reading. The diagnostic accuracy for detecting polyps requiring follow-up procedure (flexible sigmoidoscopy/colonoscopy) was 0.96 (95% CI: 0.95–0.98) for AI-assisted reading, compared to 0.91 (95% CI: 0.89–0.93) for standard reading (p<0.0001) (see Table 1). The mean reading time per video was 8.7 minutes for AI-assisted reading compared to 47.3 minutes for standard reading, representing a 5.4-fold reduction.

Conclusion

AI-assisted reading with AiSPEED™ offers the potential for greater accuracy in polyp detection and significantly reduced clinician reading times during CCE examination compared to standard reading methods.

References

1. Moen S, Vuik FER, Kuipers EJ, Spaander MCW. Artificial Intelligence in Colon Capsule Endoscopy-A Systematic Review. Diagnostics (Basel). 2022;12(8).
2. Mota J, Joao Almeida M, Mendes F, Martins M, Ribeiro T, Afonso J, et al. A Comprehensive Review of Artificial Intelligence and Colon Capsule Endoscopy: Opportunities and Challenges. Diagnostics (Basel). 2024;14(18).
3. Spada C, Piccirelli S, Hassan C, Ferrari C, Toth E, Gonzalez-Suarez B, et al. AI-assisted capsule endoscopy reading in suspected small bowel bleeding: a multicentre prospective study. Lancet Digit Health. 2024;6(5):e345-e53.
4. Spada C, Hassan C, Galmiche JP, Neuhaus H, Dumonceau JM, Adler S, et al. Colon capsule endoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2012;44(5):527-36.
5. PillCam COLON 2 for investigation of the colon through direct visualisation [Internet]. NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE. August 2024. Available from: https://www.nice.org.uk/guidance/gid-dg10083/documents/final-scope-2.

Disclosure

Hagen Wenzek serves as the CEO, and Elizabeth White is the Project Manager at Corporate Health International which owns the ​intellectual property of AiSPEED^TM

Introduction

Etrasimod is an investigational, once-daily, oral, selective sphingosine 1‑phosphate (S1P)_1,4,5 receptor modulator in development for the treatment of moderately to severely active ulcerative colitis (UC). In the ELEVATE UC 52 trial, primary and key secondary efficacy endpoints at Week 52 were evaluated among all patients randomised at baseline. The efficacy of etrasimod can be further characterised by evaluating efficacy endpoints at Week 52 among the subset of patients who met each efficacy endpoint at the end of the induction period (Week 12).

Aims & Methods

Here, we report proportions of patients receiving etrasimod that sustained induction efficacy endpoints at Week 52. In ELEVATE UC 52 (NCT03945188), patients (16–80 years) with moderately to severely active UC (defined as modified Mayo Score 4–9, endoscopic subscore ≥2 and rectal bleeding subscore [RBS] ≥1) were randomised 2:1 to once-daily etrasimod 2 mg or placebo. The ELEVATE UC 52 clinical trial comprised a 12-week induction period followed by a 40-week maintenance period with a treat-through design. This post hoc analysis assessed efficacy endpoints at Week 52 among the subset of patients who met the following efficacy endpoints at Week 12: clinical remission, endoscopic improvement, endoscopic improvement-histologic remission, symptomatic remission and RBS of 0.

Results

In ELEVATE UC 52, 81/289 (28.0%) patients treated with etrasimod achieved clinical remission at Week 12; of these, 66.7% (54/81) sustained clinical remission at Week 52 (Table). Among the 108/289 (37.4%) patients who achieved endoscopic improvement at Week 12, 72.2% (78/108) sustained the endpoint at Week 52; of 66/289 (22.8%) who achieved endoscopic improvement-histologic remission at Week 12, 63.6% (42/66) sustained the endpoint at Week 52; of 134/289 (46.4%) patients who achieved symptomatic remission at Week 12, 74.6% (100/134) sustained the endpoint at Week 52; of 166/289 (57.4%) patients who achieved an RBS of 0 at Week 12, 75.3% (125/166) sustained the endpoint at Week 52.

Conclusion

These findings suggest efficacy endpoints achieved at Week 12 were sustained by large proportions of etrasimod-treated patients at Week 52 based on both subjective and objective measures including clinical, endoscopic and histologic efficacy responses. Further analyses of larger samples sizes with longer follow-up are needed to evaluate long-term efficacy of etrasimod in patients with moderately to severely active UC.

Disclosure

BES: research/grants, e.g. Grant/Research Support: Arena, Janssen. Lecture fees/Speakers Bureau: BMS, Janssen, Lilly, Pfizer, Takeda. Consultancy, Advisory Committee/Board Member: AbbVie, Alimentiv, Amgen, Arena, AstraZeneca, Boehringer-Ingelheim, BMS, Celltrion, Fresenius Kabi, Genentech, GSK, Janssen, Lilly, Merck, Pfizer, Prometheus Biosciences, Sun Pharma Global, Takeda Pharmaceuticals International, Teva Branded Pharmaceutical Products R&D. Shareholder/Stock Options: Ventyx Biosciences. Other non-financial support: Janssen, Lilly, Pfizer, Takeda.
SV: grant/research support: AbbVie, MSD, Pfizer, Galapagos, Takeda; consultancy/advisory: AbbVie, AbolerIS, Alimentiv, Arena, AstraZeneca, Avaxia, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, CVasThera, Dr. Falk, Eli Lilly, Ferring, Galapagos, Genentech/Roche, Gilead, Hospira, Imidomics, Janssen, Johnson & Johnson, Materia Prima, MiroBio, Morphic, MrMHealth, MSD, Mundipharma, Pfizer, Prodigest, Progenity, Prometheus, Robarts Clinical Trials, Second Genome, Shire, Surrozen, Takeda, Theravance, Tillotts, Zealand; lecture/speaker: AbbVie, Dr. Falk, Ferring, Hospira, MSD, Takeda, Tillotts.
MCD: grant/research support: Janssen; consultancy: AbbVie, Arena, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Genentech, Gilead, Janssen, Pfizer, Prometheus, Takeda, Trellus Health, UCB; shares/royalties: Trellus; directorship/ownership interests: Trellus.
BGF: consultant/on advisory board: AbbVie, AbolerIS, AgomAB, AllianThera, Amgen, AnaptysBio, Applied Molecular Transport, Arena, Avoro Capital, Atomwise, BIOJAMP, Biora, Boehringer Ingelheim, Boxer, Celsius, Celgene/Bristol-Myers Squibb, Connect, Cytoki, Disc Medicine, Duality, EcoR1, Eli Lilly, Equillium, Ermium, First Wave, FirstWord, Galapagos, Galen Atlantica, Genentech/Roche, Gilead, Gossamer, GSK, Hinge, HotSpot, InDex, Imhotex, Immunic, JAK, Janssen, Japan Tobacco., Kaleido, Landos, Leadiant, L.E.K., Lenczner Slaght, LifeSci, Lument AB, Millennium, MiroBio, Morgan Lewis, Morphic, Mylan, OM, Origo, Orphagen, Pandion, Pendopharm, Pfizer, Prometheus, Diagnostics, Play to Know AG, Progenity, Protagonist, PTM, Q32, Rebiotix, REDX, Roche, Sandoz, Sanofi, Seres, Silverback, Surrozen., Takeda, Teva, Thelium, TiGenix, Tillotts, Ventyx, VHSquared Ltd., Viatris, Ysios, YSOPIA, Zealand; speaker: AbbVie, Janssen, Takeda; Alimentiv Senior Scientific Director, provides central reading services; not a company employee, no equity stake; shareholder: Gossamer.
RP: research support: AbbVie, Janssen, Takeda, Pfizer; consultancy: Abbott, AbbVie, Abivax, Alimentiv, Amgen, Arena, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Celltrion, Cosmos, Eisai, Elan, Eli Lilly, Ferring, Galapagos, Fresenius Kabi, Genentech, Gilead, GSK, BIOJAMP, Janssen, Merck, Mylan, Novartis, Oppilan, Organon, Pandion, Pendopharm, Pfizer, Progenity, Prometheus, Protagonist, Roche, Sandoz, Satisfai, Shire, Sublimity, Takeda, Theravance, Trellus, Viatris, Ventyx, UCB; speaker: AbbVie, Amgen, Arena, Bristol-Myers Squibb, Celgene, Eli Lilly, Ferring, Fresenius Kabi, Gilead, Janssen, Merck, Organon, Pfizer, Roche, Sandoz, Shire, Takeda; member of advisory boards: AbbVie, Alimentiv, Amgen, Arena, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Ferring, Fresenius Kabi, Genentech, Gilead, GSK, BIOJAMP, Janssen, Merck, Mylan, Novartis, Oppilan, Organon, Pandion, Pfizer, Progenity, Protagonist, Roche, SandozShire, Sublimity, Takeda, Ventyx.
VJ: financial support: Celgene/Bristol-Myers Squibb, Pfizer, AbbVie, Boehringer Ingelheim, Eli Lilly, Janssen, Takeda, Gilead and TiGenix; consultancy: AbbVie, Alimentiv, Amgen, Anokion, Applied Strategic, Arena, Asahi Kasei, Asieris, AstraZeneca, BIOJAMP, Celgene/Bristol-Myers Squibb, Celltrion, Eli Lilly, Ferring, F Hoffmann La Roche, Flagship Pioneering, Fresenius Kabi, Fusion MD, Galapagos, Genentech, Gilead, GSK, Janssen, Knightslab, Organon, Landos, McKesson, Metacrine, Mylan, Pandion, Pendopharm, Pfizer, Prometheus, Protagonist, Reistone, Roche, Sandoz, Second Genome, Sorriso, Takeda, Teva, Topivert, Ventyx, Viatris, Vividion; lecture: AbbVie, Ferring, Galapagos, Janssen, Pfizer, Takeda, Bristol-Myers Squibb.
AJY: consultancy: Pfizer, Arena, Takeda, Bristol-Myers Squibb; lecture/speaker: Bristol-Myers Squibb.
MVC: grant support: Pfizer, Janssen, Novartis, Bristol-Myers Squibb; consultancy: AbbVie, Arena, Bristol-Myers Squibb, Medtronic, Pfizer, Prometheus, Eli Lilly, Janssen and Takeda; speaker: AbbVie, Janssen, Medtronic, Pfizer, Bristol-Myers Squibb, Takeda.
JP: personal: AbbVie, Arena, Athos, Atomwise, Boehringer Ingelheim, Celgene, Celltrion, Ferring, Galapagos, Genentech/Roche, GSK, Immunic, Janssen, Mirum, Morphic, Nestlé, Origo, Pandion, Pfizer, Progenity, Revolo, Takeda, Theravance and Wassermann; grant support: AbbVie, Pfizer.
MG: employee & shareholder of Pfizer AG.
CJR, PS, JW: employees & shareholders of Pfizer.
SG: financial support/grants: GSK; speaker: Janssen, AbbVie, Pfizer, Takeda, Eli Lilly, Celltrion; advisory board: Janssen, AbbVie, Takeda, Pfizer, Bristol-Myers Squibb, Gilead, Galapagos, Ferring; Steering Committee member: Janssen, Bristol-Myers Squibb, AbbVie; Drug Monitoring Committee member: Janssen.