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

Inflammatory bowel diseases (IBD) are chronic systemic conditions that affect patients' lives in various ways. To date, there is a scarce evidence correlating fecal incontinence, sexual dysfunctions, disease activity, and quality of life (QoL) in these patients. This study aimed to evaluate the impact of fecal incontinence on sexual functions such as erectile and prostatic function in a cohort of IBD patients; and to analyse the relationship among fecal incontinence, sexual function and QoL.

Aims & Methods

IBD patients were enrolled from IBD clinic of the Gastroenterology Unit of the University Hospital of Salerno. Demographic characteristics, anthropometric data, and usage of immunosuppressive drugs were collected. Patients underwent a physical examination, and laboratory tests, including C-reactive protein (CRP) and fecal calprotectin (FC). A standardized questionnaire was used to assess gastrointestinal (GI) symptoms such as abdominal pain and fecal incontinence. For the latter, we also used the Wexner score. Crohn's Disease Activity Index (CDAI) and Mayo score as well as FC levels, and endoscopic findings were used to classify IBD patients as in active or in remission phase. Patients with perianal manifestations were excluded. Hormonal values (FSH, LH, Prolactin, 17-betaestradiol, testosterone) were measured. Sexual function was evaluated using the International Index of Erectile Function (IIEF), Male Sexual Health Questionnaire (MSHQ), Ejaculatory Dysfuction (EjD), prostatic dysfunction using the National Institute of Health - Chronic Prostatitis Symptom Index (NIH-CPSI) and International Prostatic Symptoms Score (IPSS). QoL was assessed by FiQol domains (lifestyle, coping behaviour, self‐perception and depression, embarrassment).

Results

Eighty-five male IBD patients (47 Crohn's disease [CD] and 38 ulcerative colitis [UC]), were enrolled. Mean age was 43.7 ± 15.9 years; mean BMI was 36.4±25.5 Kg/m². Twenty-four CD patients had an active disease and 23 were in remission, while 20 UC patients had an active disease and 18 were in remission. UC patients showed significantly higher fecal incontinence and Wexner scores compared to CD patients (1.0±1.9 vs 0.4±1.2, p=0.05 and 2.84±4.2 vs 2.3±1.1, p=0.01, respectively). Only the Mayo score significantly correlated with Wexner score (Rs=0.578; p<0.001), and fecal incontinence (Rs=0.584; p<0.001). Sexual function, evaluated by erectile and prostatic scores, nicely correlated each other’s (p<0.05 in all cases). However, no association was found between fecal incontinence and all sexual function scores. The FiQol domain self‐perception and depression was significantly associated with IIEF (p=0.01).

Conclusion

This study highlighted the prevalence of fecal incontinence is higher in UC than CD patients. However, fecal incontinence did not impact on sexual function, evaluated by erectile and prostatic scores. QoL influenced erectile function.

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

Irritable bowel syndrome (IBS) is a common disorder of gut brain interaction (DGBI) characterized by abdominal pain associated with altered bowel habits – symptoms are often related to food intake. Confocal laser endomicroscopy (CLE) has shown acute food-triggered disruption of the epithelial barrier in the duodenum of IBS patients. While this technique promises new insights into the pathophysiology of IBS, image interpretation is subjective and interobserver agreement rates have not been assessed.

Aims & Methods

Aim: To assess the agreement rate between assessors regarding acute food induced mucosal changes visualized by CLE.
Methods: In Rome IV IBS (non-constipated) patients, allergic sensitization to nutrients was excluded by specific serum Immunoglobulin E tests. CLE was performed during upper GI endoscopy: duodenal mucosa was visualized before and after sequential application of 10mL dissolved aliquots of lyophilized fish, nuts, egg white, soy, milk and wheat. Two investigators (experience of ≥20 exams each) assessed separately recorded sequences for the presence or absence of acute mucosal alterations defined as fluorescence leakage and cell shedding visualized on ≥3 different mucosal spots. Assessors were blinded for patient characteristics, and for the timepoint of recordings (i.e. baseline or after food administration). Agreement rates are reported in percent and using Cohen’s Kappa computed with Rstudio.

Results

A total of 75 video sequences from 22 procedures in 13 patients were interpreted. Regarding presence or absence of mucosal alterations, assessors agreed in 81% (61/75) of assessed sequences resulting in a Cohen’s Kappa of 0.63.
Overall, 52% (32/61) of sequences with agreement were judged by both assessors to present leakiness and cell shedding whereas 48% (29/61) were considered normal.

Conclusion

When assessed in a blinded manner, mucosal leakiness is visualized on CLE recordings with a high agreement rate between assessors and substantial agreement when accounting for random chance agreement. Further increasing agreement rates by possibly modifying criteria might increase the validity of this technique.

Introduction

Gender-specific differences in adult patients with immune mediated diseases like inflammatory bowel diseases (IBD) or coeliac diseases are increasingly recognised (1). In paediatric patients, gender differences in the incidence of IBD have been identified in a pooled analysis of population-based studies (2). However, gastrointestinal (GI) symptoms associated with paediatric IBD or coeliac disease and possible gender differences in GI symptoms have not been systematically studied.

Aims & Methods

Our aim was to utilise the newly developed, validated paediatric Structured Assessment of Gastrointestinal Symptoms (pSAGIS) scale to systematically assess GI symptoms in children with Crohn’s disease, ulcerative colitis, and coeliac disease by gender in an paediatric gastrointestinal outpatient clinic.
The pSAGIS is a patient-reported outcome measure (PROM) that consists of 21 GI-related questions and assesses the type and five severity grades of symptoms.
pSAGIS scales were completed by patients or their caregivers attending the GI outpatient unit of St. Anna Children’s Hospital, Vienna, Austria between the years 2016 and 2020. The diagnoses of patients were established on clinical terms after a complete examination deemed clinically necessary. Based on pSAGIS, an overall GI-symptom score was calculated as the sum of each individual symptom score for patients with Crohn’s disease, ulcerative colitis and coeliac disease, and symptom scores were compared between female and male patients. In addition, GI symptoms were summarised in five symptom groups (abdominal pain, dyspepsia, diarrhea, constipation, dysphagia/nausea). Data are given as mean ± standard deviation (SD), a p-value <0.05 was considered significant.

Results

From 3344 collected pSAGIS questionnaires 12.9% (n=430) were completed by children diagnosed with Crohn’s disease (71.9% male, 28.1% female), 9.0% (n=302) with ulcerative colitis (57.0% male, 43.0% female), and 24.7% (n=827) with coeliac disease (36.4% male, 63.6% female). In patients with Crohn’s disease the overall GI-symptom score was significantly higher among female patients comparing to male patients (7.3±10,1 vs. 2. 8±4,2, p<0.001) while in patients with ulcerative colitis overall symptom scores were higher in male than in female patients (5.6±8.5 vs 2.9±5.9; p=0.002). The table shows scores of symptom groups in patients with Crohn's disease and ulcerative colitis. The overall GI symptom score was low in patients with coeliac disease, and no significant differences were found between male and female coeliac patients (3.1±4.6 vs. 3.9±6.4, p=0,064).

Conclusion

Gender specific symptoms and symptom burden exist in paediatric patients with Crohn’s disease and ulcerative colitis. These gender differences may affect time to diagnosis, initiation of treatment and adherence to treatment and need further investigation. The pSAGIS is an easy adjunct to gastrointestinal history taking and allows a valid and systematic symptom assessment in a paediatric outpatient clinic.

References

(1) Greuter T et al, Digestion 2020; (2) Shah SC et al, Gastroenterology 2018

Introduction

Microscopic colitis (MC) is an inflammatory gastrointestinal disease which typically presents with chronic watery diarrhea without blood. Despite a rising incidence over the last decades (1), studies on health economic outcomes are lacking.

Aims & Methods

In this cost-of-illness study, we estimate the societal economic burden of MC encompassing costs for healthcare, medications, and work loss, by the use of real-world data from Swedish health registers.
Through biopsy reports from Sweden’s 28 pathology departments, we identified 11,530 adult patients with MC as of January 1, 2017. Each patient was compared to up to 5 general-population comparators matched on date of birth, sex, and county of residence. Healthcare costs were based on prescription medications as well as non-primary outpatient visits and hospitalizations that included endoscopic procedures, while productivity losses were derived from work loss due to sick leave or disability leave. Mean differences were adjusted for age, sex, and education level. All costs were adjusted for inflation and converted from Swedish currency, SEK, to USD according to the annual average conversion rate in 2016 (1 USD = 8.5613 SEK or 0.9040 EUR).

Results

In 2016, patients with MC had a mean annual cost of $11,782 as compared with $6,170 in general-population comparators, corresponding to an annual excess cost of $5,615 per patient (adjusted mean difference $5,628 [95%CI: $5,278-$5,978], Table 1).
Even though less than half of the patients with MC were of working age (18-64 years, 42.5%), work loss was the largest cost component and accounted for more than half of the mean annual excess cost (57.7%). Excess costs related to hospitalizations accounted for 18.1%, whereas costs related to outpatient visits and medications accounted for 12.6% and 13.4% respectively. Although patients with MC had an increased use of MC-related medications such as local acting steroids (ATC code A07EA), these costs were comparatively small (mean annual cost, $106). Furthermore, MC-related healthcare costs such as colonoscopies, or outpatient visits and hospitalizations related to MC as defined by ICD code K.528, were negligible (mean annual cost, $68, $72 and $15 respectively).
The total annual societal cost of MC in Sweden was $135.9 million in 2016. By subtracting the baseline cost observed in general-population comparators, $64.7 million was found to be attributable to MC and MC-comorbidity.

Table 1. Use and cost of healthcare, prescription medications, and work loss in prevalent patients with microscopic colitis (MC) and general-population comparators in Sweden, 2016.

Conclusion

Patients with MC had an increased mean annual societal cost which was primarily driven by work loss. Healthcare costs specifically related to MC did not seem to be a major contributor to excess costs. Instead, excess healthcare costs in patients with MC are likely to be driven by concomitant disease. The societal economic burden of MC in Sweden was $135.9 million in 2016 with a population of 10.0 million and a prevalence of around 0.1%.

References

1. Bergman D, Clements MS, Khalili H, Agréus L, Hultcrantz R, Ludvigsson JF. A nationwide cohort study of the incidence of microscopic colitis in Sweden. Aliment Pharmacol Ther. 2019 Jun;49(11):1395-1400.

Disclosure

Dr Ludvigsson coordinates a study on behalf of the Swedish IBD quality register (SWIBREG). That study has received funding from the Janssen corporation. Dr Ludvigsson has also received financial support from MSD to develop a paper reviewing national healthcare registers in China.