Introduction

Computed tomography colonography (CTC) has been developed as a less invasive alternative method to colonoscopy for colorectal cancer screening. Some subjects who underwent CTC reported abdominal pain induced by carbon dioxide gas injection during examination. We speculated that pain perception during CTC might reflect visceral hypersensitivity related to irritable bowel syndrome (IBS).

Aims & Methods

In this study, we investigated whether pain perception induced by carbon dioxide gas injection during CTC is different between patients with IBS and healthy controls. Furthermore, we evaluated the correlation between the pain score during CTC and the severity of the IBS symptom or the quality of life of patients with IBS. A prospective study of consecutively registered patients who underwent CTC for colorectal cancer screening in a single medical center was conducted. IBS was diagnosed using the Rome IV criteria, and patients with IBS were classified into IBS subgroups according to the predominant stool pattern experienced by the patient. In addition, all subjects completed the IBS Severity Scale (IBS-SS) and IBS-QOL questionnaire. Pain perception during CTC was quantified using the visual analog scale (VAS) at six time points during the CTC as follows: (1) before CTC, (2) immediately after carbon dioxide gas injection, (3) until the injection pressure reached a plateau (18 mmHg), (4) in the prone position after carbon dioxide gas injection, (5) in the supine position after carbon dioxide gas injection, and (6) after CTC. We also evaluated the association between the VAS and IBS-SS scores.

Results

One hundred twenty-three subjects who underwent CTC were enrolled in this study. Thirteen subjects were excluded because of incomplete questionnaires (n = 10) or a diagnosis of colorectal cancer with CTC (n = 3). Fifteen patients were diagnosed as having IBS on the basis of the Rome IV criteria for IBS. Patients with IBS were classified into the following groups: IBS with diarrhea (IBS-D, n = 1), IBS with constipation (IBS-C, n = 3), mixed IBS (IBS-M, n = 3), and unspecified IBS (IBS-U, n = 8). No significant differences in background characteristics, including age, sex, alcohol consumption, and smoking habit, were found between the IBS and control groups. The volume of carbon dioxide gas injected during CTC did not show a significant difference between the two groups. The total colon length was not significantly different between the two groups. The VAS score of the IBS groups was significantly higher than that of the control group at two time points, (2) immediately after carbon dioxide gas injection (p < 0.01) and (3) until the injection pressure reached a plateau (18 mmHg; p < 0.01). The maximum VAS score during CTC was also significantly higher in the IBS groups than in the control group (p < 0.05). Although the IBS-SS score was significantly higher in the IBS groups than in the control group, we found no significant correlation between the VAS and IBS-SS scores in the IBS groups. The IBS-QOL score also did not show any significant correlation with the VAS score.

Conclusion

Our study indicates that pain perception evaluated using the VAS during CTC might be a potential diagnostic method for IBS. Further study is necessary to clarify the association between pain perception induced by CTC and IBS severity.

Introduction

A novel device intended to evaluate motility in patients at risk for dysmotility and enteral feeding intolerance was developed. This VIPUN Gastric Monitoring System (GMS) consists of a feeding tube with a balloon attached to its distal end and a control unit. Once the balloon is positioned in the stomach the control unit can inflate the balloon, record intra-balloon pressure and analyze gastric motility.

Aims & Methods

Our aim was to validate the GMS as a gastric motility monitoring system by comparing its performance to the gold standard, high-resolution manometry. The primary hypothesis was that the contraction durations recorded by the GMS and manometry are strongly correlated (ρ > 0.70). Secondary objectives: To correlate the contraction frequency observed by expert gastroenterologists and by GMS analysis software on GMS and manometry, and to observe gastric accommodation upon nutrient intake.
In this monocentric, single-arm, interventional study, a GMS prototype (VIPUN Medical, Belgium) was tested in healthy adults. A solid state manometry catheter (UniTip, Unisensor AG, Switzerland) was used as comparator. The balloon catheter was inserted through the nose. The manometry catheter was inserted through the other nare and positioned with the tip in the duodenum, as verified using fluoroscopy. Afterwards, the GMS catheter balloon was inflated with 120 mL air. The participant was placed in semi-recumbent position for the 2.5 h pressure measurement. After 2 h, a liquid meal (400 kcal, 1.5 kcal/mL) was infused via the GMS catheter.
For manometry, only the channels that were consistently in the stomach were analyzed. Duration of contractility (primary outcome) was calculated as the time baseline-corrected pressure waves exceeded a subject- and technology-specific pressure threshold (1). The identification of individual gastric contractions (secondary outcome) was done by two independent readers, a third reader served as adjudicator. Additionally, GMS software was used for the detection of individual gastric contractions. Results are shown as mean (standard deviation).

Results

13 healthy volunteers (6 women, 27.5 (8.1) years) were included. GMS catheter placement was feasible and safe. Intragastric balloon inflation was well-tolerated. No serious or unanticipated adverse events occurred.
For the primary outcome, the Spearman correlation between the contraction duration recorded by GMS and manometry was 0.96 (p < 0.01). The sum of contractile activity per subject was similar: 2588.7 (1872.2) and 2722.3 (1768.7) seconds on manometry and GMS, respectively (p = 0.44, paired t-test, see Table 1).
For the number of contractions identified visually by readers, the correlation between GMS and manometry was 0.71 (p < 0.01) . Using GMS software for detection of individual contractions on GMS, the correlation with reader-identified contractions on manometry was 0.87 (p < 0.01).
Nutrient infusion resulted in a significant decrease in tonic (-1.7 (0.96) mmHg) and phasic (-3.4 (3.1) contractions/10 min) contractility.

Conclusion

The observed strong correlations with the gold standard, manometry, validate the performance of the VIPUN GMS as a gastric monitoring system.

References

1. Janssen P, Goelen N, Tack J. A comparison of various intragastric balloons for the assessment of gastric motility. Neurogastroenterol Motil. 2018;30(12):e13453.

Introduction

Adenoma detection rate (ADR) has been inversely associated with the risk of interval colorectal cancer. According to a recent positional statement of the European Society of Gastrointestinal Endoscopy (ESGE), Artificial Intelligence is expected to increase ADR.

Aims & Methods

The aim of the study is to evaluate the benefit of a computer-aided detection device (CADe Endo-AID) in a consecutive, non-selected series of patients undergoing colonoscopy. This is an interim analysis of an Italian prospective multicenter randomized control trial (RCT) that included patients aged 40-85 scheduled for screening, surveillance or diagnostic colonoscopy randomly assigned to CADe (Endo-AID, Olympus, Japan) or standard colonoscopy (SC). Patients with a Boston Bowel Preparation Scale (BBPS) < 2 in any segment were excluded from the analysis. Polyp Detection Rate (PDR), Polyp Per Colonoscopy (PPC), ADR, Adenoma Per Colonoscopy (APC), Serrated Detection Rate (SDR), Advanced adenoma (villous histology and/or high-grade dysplasia and/or diameter ≥ 1 cm) and the presence of ≥ 3 precancerous lesions were evaluated in the two groups.

Results

901 patients were enrolled of whom 62 were excluded for inadequate bowel cleansing. Therefore, 839 subjects (428 CADe vs 411 SC) were included in the final analysis. ADR was significantly higher in CADe than in the control group [50.2% (215/428) vs 41.6% (171/411) p= 0.01]. CADe also significantly increased PDR, PPC, and APC [67.5% (289/428) vs 55.5% (228/411) p< 0.01; 1.68 vs 1.34 p< 0.01; 1.17 vs 0.86 p< 0.01, respectively]. SDR, advanced adenomas, and ≥ 3 precancerous lesions were higher in the intervention group without reaching statistical significance. Endpoints were evaluated in a subgroup analysis for BBPS scores (116 CADe/115 SC patients with BBPS 6 and 266 CADe/244 SC patients with BBPS 9). Results are summarized in Table 1.

Conclusion

The preliminary results of the present RCT show an increase in the diagnostic yield of AI-assisted colonoscopy in all the calculated indicators in a non-selected population undergoing colonoscopy.

Introduction

Ozanimod (OZA), a sphingosine 1-phosphate (S1P) receptor modulator that selectively targets S1P₁ and S1P₅, is approved in the European Union, United States, and other countries for the treatment of moderately to severely active ulcerative colitis (UC). Mucosal healing (MH), a key treatment goal for patients (pts) with UC, is associated with improved long-term pt outcomes.

Aims & Methods

The goal of this analysis was to determine the rate of early MH after treatment with OZA at Week (W) 10 using stringent MH criteria (mucosal endoscopy subscore [MES] = 0 plus histologic remission [Geboes score <2.0]) and to assess the relationship between achievement of stringent MH at W10 and clinical outcomes at W52. Outcomes were compared to pts achieving MH using a standard definition (MES ≤1 plus histologic remission). This analysis included pts from True North (NCT02435992) who achieved clinical response on once-daily oral OZA 0.92 mg at W10 and continued OZA during the 42-wk maintenance period. In this post hoc analysis, we examined MH, clinical remission, and corticosteroid (CS)–free remission at W52 in pts with stringent MH vs without stringent MH at W10 and with stringent MH vs with standard MH.

Results

Of the 230 pts who achieved clinical response on OZA at W10 and continued OZA during the maintenance period, 44 (19.1%) achieved MH using a standard definition and 13 (5.7%) achieved stringent MH at W10. Demographic and clinical characteristics were generally balanced between OZA-treated pts with stringent MH (n=13) and without stringent MH (n=217) at W10. Notably, there were fewer male pts with stringent MH vs without stringent MH, all pts with stringent MH had moderate disease (based on endoscopy), and more pts with stringent MH vs without stringent MH had left-sided UC disease. CS use at screening and prior tumor necrosis factor inhibitor (TNFi) use were lower in those with stringent MH vs without stringent MH. Similar differences in disease severity, extent of disease, and CS and TNFi use were seen in pts with stringent MH vs standard MH. At W52, more pts treated with OZA with stringent MH at W10 vs without stringent MH at W10 had clinical remission (53.8% vs 35.9%), CS-free remission (53.8% vs 30.4%), MH (61.5% vs 27.6%), endoscopic improvement (61.5% vs 44.7), and histologic remission (61.5% vs 31.8%). Except for endoscopic improvement, a slightly higher percentage of pts with stringent MH vs standard MH at W10 achieved clinical outcomes at W52 (Table).

Conclusion

While difficult to achieve, a small proportion of pts treated with OZA experienced stringent MH by W10. Compared with pts who achieved standard MH at W10, those with stringent MH at W10 demonstrated numerically better clinical outcomes at W52 on OZA treatment. Achieving stringent MH at W10 correlated with better clinical, endoscopic, and mucosal outcomes at W52.

Disclosure

The study was funded by Bristol Myers Squibb, Princeton, NJ, USA.
WR: speaker for 4SC, Abbott Laboratories, AbbVie, Aesca, Aptalis, Astellas, Centocor, Celltrion, Danone Austria, Elan, Falk Pharma GmbH, Ferring, Immundiagnostik, Medice, Mitsubishi Tanabe Pharma Corporation, MSD, Otsuka, PDL, Pharmacosmos, PLS Education, Schering-Plough, Shire, Takeda, Therakos, Vifor, and Yakult; consulted for Abbott Laboratories, AbbVie, Aesca, Algernon, Amgen, AM Pharma, AMT, AOP Orphan, Arena, Astellas, AstraZeneca, Avaxia, Roland Berger GmbH, Bioclinica, Biogen IDEC, Boehringer Ingelheim, Bristol Myers Squibb, Calyx, Celgene, Cellerix, Celltrion, Centocor, ChemoCentryx, Covance, Danone Austria, DSM, Elan, Eli Lilly, Ernst & Young, Falk Pharma GmbH, Ferring, Galapagos, Gatehouse Bio, Genentech, Gilead, Grünenthal, ICON, Index Pharma, Inova, Intrinsic Imaging, Janssen, Johnson & Johnson, Kyowa Hakko Kirin Pharma, Landos, Lipid Therapeutics, LivaNova, Mallinckrodt, MedAhead, MedImmune, Millennium, Mitsubishi Tanabe Pharma, MSD, Nash Pharmaceuticals, Nestle, Nippon Kayaku, Novartis, Ocera, OMass, Otsuka, Parexel, PDL, Peri Consulting, Pharmacosmos, Philip Morris Institute, Pfizer, Procter & Gamble, Prometheus, Protagonist, Provention, Quell Therapeutics, Robarts Clinical Trial, Sandoz, Schering-Plough, Second Genome, Seres, Setpoint Medical, Sigmoid, Sublimity, Takeda, Teva, Therakos, Theravance, TiGenix, UCB, Vifor, Zealand, and Zyngenia; served as an advisory board member for 4SC, Abbott Laboratories, AbbVie, Aesca, Amgen, AM Pharma, Astellas, AstraZeneca, Avaxia, Biogen IDEC, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Cellerix, Celltrion, Centocor, ChemoCentryx, Danone Austria, DSM, Elan, Ferring, Galapagos, Genentech, Grünenthal, Inova, Janssen, Johnson & Johnson, Kyowa Hakko Kirin Pharma, Lipid Therapeutics, MedImmune, Millennium, Mitsubishi Tanabe Pharma, MSD, Nestle, Novartis, Ocera, Otsuka, PDL, Pharmacosmos, Pfizer, Procter & Gamble, Prometheus, Sandoz, Schering-Plough, Second Genome, Setpoint Medical, Takeda, Therakos, TiGenix, UCB, Zealand, and Zyngenia; received research funding from Abbott Laboratories, AbbVie, Aesca, Centocor, Falk Pharma GmbH, Immundiagnostik, Janssen, MSD, Sandoz, and Takeda.
AH: Consultant, advisory board member, or speaker for AbbVie, Atlantic, Bristol-Myers Squibb, Celltrion, Falk, Ferring, Janssen, MSD, Napp Pharmaceuticals, Pfizer, Pharmacosmos, Shire, and Takeda. Global Steering Committee for Genentech.
CS: served as a speaker for AbbVie, Bristol Myers Squibb, Janssen, Pfizer, Takeda, and UCB.
RKC: consulted for AbbVie, Bristol Myers Squibb, Janssen, LabCorp, Pfizer, Samsung Bioepis, and Takeda.
HAA, AJ, HW, and MTO: employees and/or shareholders of Bristol Myers Squibb.
RL: consulted for Bristol Myers Squibb and Pfizer.
JA: received consulting fees from AbbVie, BioFire Diagnostics, Janssen, and Pfizer; received research grants from BioFire Diagnostics.