A Preclinical Blinded Randomized-Controlled Trial Evaluating the Clinical Relevance of Polyp Size Measurement Using a Virtual Scale Endoscope.

Background: The virtual scale endoscope (VSE) helps endoscopists measure colorectal polyp size more accurately compared to visual assessment (VA). However, previous studies were not adequately powered to evaluate the sizing of polyps at clinically relevant size thresholds and relative accuracy for size subgroups. Methods: We created 64 artificial polyps of varied sizes and Paris class morphology, randomly assigned 1:1 to be measured (383 total measurement datapoints with VSE and VA by 6 endoscopists blinded to true size) in a colon model. We added data from two previous trials (480 measurement datapoints). We evaluated for correct classification of polyps into size groups at 3 mm, 5 mm, 10 mm, and 20 mm size thresholds and the relative size measurement accuracy for diminutive polyps (≤5 mm), small polyps (5-9 mm), large polyps at 10-19 mm, and polyps (≥20). Results: VSE had significantly less size group misclassifications at the 5 mm, and 10 mm thresholds (28 percent vs. 45 percent, P = 0.0159 and 26 percent vs. 44 percent, P = 0.0135, respectively). For the 3 mm and 20 mm thresholds, VSE had lower misclassifications; however, this was not statistically significant (36 percent vs. 46 percent, P = 0.3853 and 38 percent vs. 41 percent, P = 0.2705, respectively). The relative size measurement accuracy was significantly higher for VSE compared to VA for all size subgroups (diminutive (P < 0.01), small polyps (P < 0.01), 10-19 mm (P < 0.01), and ≥20 mm (P < 0.01)). Conclusion: VSE outperforms VA in categorizing polyps into size groups at the clinically relevant size thresholds of 5 mm and 10 mm. Using VSE resulted in significantly higher relative measurement accuracy for all size subgroups.

Autonomous Artificial Intelligence vs Artificial Intelligence-Assisted Human Optical Diagnosis of Colorectal Polyps: A Randomized Controlled Trial.

BACKGROUND & AIMS: Artificial intelligence (AI)-based optical diagnosis systems (CADx) have been developed to allow pathology prediction of colorectal polyps during colonoscopies. However, CADx systems have not yet been validated for autonomous performance. Therefore, we conducted a trial comparing autonomous AI to AI-assisted human (AI-H) optical diagnosis. METHODS: We performed a randomized noninferiority trial of patients undergoing elective colonoscopies at 1 academic institution. Patients were randomized into (1) autonomous AI-based CADx optical diagnosis of diminutive polyps without human input or (2) diagnosis by endoscopists who performed optical diagnosis of diminutive polyps after seeing the real-time CADx diagnosis. The primary outcome was accuracy in optical diagnosis in both arms using pathology as the gold standard. Secondary outcomes included agreement with pathology for surveillance intervals. RESULTS: A total of 467 patients were randomized (238 patients/158 polyps in the autonomous AI group and 229 patients/179 polyps in the AI-H group). Accuracy for optical diagnosis was 77.2% (95% confidence interval [CI], 69.7-84.7) in the autonomous AI group and 72.1% (95% CI, 65.5-78.6) in the AI-H group (P = .86). For high-confidence diagnoses, accuracy for optical diagnosis was 77.2% (95% CI, 69.7-84.7) in the autonomous AI group and 75.5% (95% CI, 67.9-82.0) in the AI-H group. Autonomous AI had statistically significantly higher agreement with pathology-based surveillance intervals compared to AI-H (91.5% [95% CI, 86.9-96.1] vs 82.1% [95% CI, 76.5-87.7]; P = .016). CONCLUSIONS: Autonomous AI-based optical diagnosis exhibits noninferior accuracy to endoscopist-based diagnosis. Both autonomous AI and AI-H exhibited relatively low accuracy for optical diagnosis; however, autonomous AI achieved higher agreement with pathology-based surveillance intervals. (ClinicalTrials.gov, Number NCT05236790).

Gut microbiome-associated predictors as biomarkers of response to advanced therapies in inflammatory bowel disease: a systematic review.

Loss of response to therapy in inflammatory bowel disease (IBD) has led to a surge in research focusing on precision medicine. Three systematic reviews have been published investigating the associations between gut microbiota and disease activity or IBD therapy. We performed a systematic review to investigate the microbiome predictors of response to advanced therapy in IBD. Unlike previous studies, our review focused on predictors of response to therapy; so the included studies assessed microbiome predictors before the proposed time of response or remission. We also provide an update of the available data on mycobiomes and viromes. We highlight key themes in the literature that may serve as future biomarkers of treatment response: the abundance of fecal SCFA-producing bacteria and opportunistic bacteria, metabolic pathways related to butyrate synthesis, and non-butyrate metabolomic predictors, including bile acids (BAs), amino acids, and lipids, as well as mycobiome predictors of response.

Comparing size measurements of simulated colorectal polyp size and morphology groups when using a virtual scale endoscope or visual size estimation: Blinded randomized controlled trial.

OBJECTIVES: The virtual scale endoscope (VSE) allows projection of a virtual scale onto colorectal polyps allowing real-time size measurements. We studied the relative accuracy of VSE compared to visual assessment (VA) for the measuring simulated polyps of different size and morphology groups. METHODS: We conducted a blinded randomized controlled trial using simulated polyps within a colon model. Sixty simulated polyps were evenly distributed across four size groups (1-5, >5-9.9, 10-19.9, and ≥20 mm) and three Paris morphology groups (flat, sessile, and pedunculated). Six endoscopists performed polyp size measurements using random allocation of either VA or VSE. RESULTS: A total of 359 measurements were completed. The relative accuracy of VSE was significantly higher when compared to VA for all size groups >5 mm (P = 0.004, P < 0.001, P < 0.001). For polyps ≤5 mm, the relative accuracy of VSE compared to VA was not significantly higher (P = 0.186). The relative accuracy of VSE was significantly higher when compared to VA for all morphology groups. VSE misclassified a lower percentage of >5 mm polyps as ≤5 mm (2.9%), ≥10 mm polyps as <10 mm (5.5%), and ≥20 mm polyps as <20 mm (21.7%) compared to VA (11.2%, 24.7%, and 52.3% respectively; P = 0.008, P < 0.001, and P = 0.003). CONCLUSION: Virtual scale endoscope had significantly higher relative accuracies for every polyp size group or morphology type aside from diminutive. VSE enables the endoscopist to better classify polyps into correct size categories at clinically relevant size thresholds of 5, 10, and 20 mm.

Effectiveness, safety, and drug sustainability of biologics in elderly patients with inflammatory bowel disease: A retrospective study.

BACKGROUND: Biologic therapy resulted in a significant positive impact on the management of inflammatory bowel disease (IBD) however data on the efficacy and side effects of these therapies in the elderly is scant. AIM: To evaluate retrospectively the drug sustainability, effectiveness, and safety of the biologic therapies in the elderly IBD population. METHODS: Consecutive elderly (≥ 60 years old) IBD patients, treated with biologics [infliximab (IFX), adalimumab (ADAL), vedolizumab (VDZ), ustekinumab (UST)] followed at the McGill University Inflammatory Bowel Diseases Center were included between January 2000 and 2020. Efficacy was measured by clinical scores at 3, 6-9 and 12-18 mo after initiation of the biologic therapy. Patients completing induction therapy were included. Adverse events (AEs) or serious AE were collected during and within three months of stopping of the biologic therapy. RESULTS: We identified a total of 147 elderly patients with IBD treated with biologicals during the study period, including 109 with Crohn's disease and 38 with ulcerative colitis. Patients received the following biologicals: IFX (28.5%), ADAL (38.7%), VDZ (15.6%), UST (17%). The mean duration of biologic treatment was 157.5 (SD = 148) wk. Parallel steroid therapy was given in 34% at baseline, 19% at 3 mo, 16.3% at 6-9 mo and 6.5% at 12-18 mo. The remission rates at 3, 6-9 and 12-18 mo were not significantly different among biological therapies. Kaplan-Meyer analysis did not show statistical difference for drug sustainability (P = 0.195), time to adverse event (P = 0.158) or infection rates (P = 0.973) between the four biologics studied. The most common AEs that led to drug discontinuation were loss of response, infusion/injection reaction and infection. CONCLUSION: Current biologics were not different regarding drug sustainability, effectiveness, and safety in the elderly IBD population. Therefore, we are not able to suggest a preferred sequencing order among biologicals.

Lidocaine before esophageal manometry and ambulatory pH monitoring: A randomized controlled trial.

BACKGROUND: Lidocaine is commonly applied to improve the tolerance of esophageal manometry (EM) and ambulatory pH monitoring (PM). We recently published data suggesting a benefit to this practice and we aimed to confirm these findings in a randomized trial. METHODS: We conducted a double-blind, randomized trial of lidocaine nasal spray versus placebo (saline) before EM and PM. Patients referred to our center who met inclusion criteria were enrolled. Patients were asked to fill a questionnaire after their test and patient-reported adverse effects were compared. KEY RESULTS: Three hundred and four patients were enrolled in our trial. Lidocaine and placebo groups were demographically similar. The primary outcome, pain during catheter insertion, occurred in 60/148 (40.5%) patients in the lidocaine group versus in 72/152 (47.4%) patients in the placebo group (OR: 0.76 [95% CI: 0.48-1.20]; p = 0.23). Patients receiving lidocaine were less likely to report nausea during test recording (OR: 0.48 [95% CI: 0.24-0.91]; p = 0.02) and reported slightly lower intensity of pain during both catheter insertion and test recording (4.68 ± 2.06 versus 5.41 ± 2.24 on 10; p = 0.048 and 3.71 ± 2.00 versus 4.93 ± 2.55 on 10; p = 0.03, respectively). Furthermore, patients receiving lidocaine were less likely to report their test as globally uncomfortable and painful (57% vs. 75%; p = 0.003 and 14% vs. 21%; p = 0.02, respectively). No events of systemic lidocaine toxicity occurred during the study period. CONCLUSIONS: Routine use of lidocaine before esophageal function tests does not reduce pain during catheter insertion but may provide other modest benefits with limited toxicity.

Predictors of Small Intestinal Bacterial Overgrowth in Symptomatic Patients Referred for Breath Testing.

BACKGROUND: Indications for a breath test (BT) are well established in the symptomatic patient with risk factors predisposing them to small intestinal bacterial overgrowth (SIBO). Characteristics and the profile of this population are not well known. Our objective was to study the characteristics of patients undergoing a BT for SIBO and to identify factors associated with a positive BT. METHODS: Retrospective study was conducted from 2012 to 2016 at the neurogastroenterology unit of the Centre Hospitalier de l'Universite de Montreal (CHUM). All patients who completed a BT (lactulose and/or glucose) were included. Demographics and clinical factors were analyzed to identify predictors of positive BT. Type of antibiotic treatment and clinical response were compiled. Groups of patients with (SIBO+) and without SIBO (SIBO-) were also compared. RESULTS: A total of 136 patients were included in the study (mean age 51.2, range 20 - 80 years; 63% women), and SIBO was detected in 33.8% (n = 46). Both groups were similar in terms of age, body mass index, and gender. SIBO was significantly associated with the presence of abdominal pain (odds ratio (OR) = 4.78; P < 0.05), bloating (OR = 5.39; P < 0.05), smoking (OR = 6.66; P < 0.05), and anemia (OR = 4.08; P < 0.05). No association was identified with gender, age, obesity, and risk factors for SIBO. Antibiotics were used in 43% of patients with a positive BT, but clinical response was not significantly different in the subgroup that received antibiotics versus the subgroup that did not. CONCLUSIONS: The prevalence of SIBO is high in symptomatic patients who underwent breath testing. Abdominal pain, bloating, smoking, and anemia are strongly associated with SIBO. Treatment of SIBO with antibiotics needs to be further investigated to better determine its efficacy on gastrointestinal symptoms.

High occurrence of small intestinal bacterial overgrowth in primary biliary cholangitis.

BACKGROUND: Primary biliary cholangitis (PBC) is a chronic autoimmune liver disease affecting mainly middle-aged women. An alteration in intestinal motility has been well documented in cirrhosis predisposing to small intestinal bacterial overgrowth (SIBO). Patients with PBC frequently complain of various gastrointestinal symptoms compatible with SIBO. No study has specifically been published to this day to determine the occurrence of SIBO in PBC. Our objective was to determine the prevalence of SIBO in patients with PBC. METHODS: Retrospective study from 2010 to 2018. All patients diagnosed with PBC during this period had a systematic screening for SIBO in their diagnostic workup. The diagnosis of SIBO was made by a carbohydrate breath test (lactulose and/or glucose). Clinical and paraclinical factors of patients were compared with a control group of healthy subjects. KEY RESULTS: Ninety-eight subjects were included in the study (mean age 49, range 21-88 years) including 58 patients with PBC and 40 healthy subjects. The PBC group was older than the control group (mean age 56, range 31-88 vs 39, range 21-62 years; P < .001), but identical for gender and body mass index. The prevalence of SIBO was higher in PBC versus controls (32.8% vs 2.5%; P < .001). The PBC group with SIBO had significantly more diarrhea (78.9% vs 35.9%; P < .05) than the PBC group without SIBO, but the prevalence of abdominal pain and bloating was similar. CONCLUSIONS & INFERENCES: The high occurrence of SIBO in PBC may explain some of the frequently reported gastrointestinal symptoms. This study justifies the systematic screening for SIBO in PBC.