Endoscopic Measurement Research Articles

P0184 Molecular signature of bowel urgency in Ulcerative Colitis

Abstract Background Bowel urgency is a ‘top three’ symptom of concern to patients with ulcerative colitis (UC), but the mechanisms are unclear [1]. Determining the molecular signatures of bowel urgency would reveal targetable mechanisms and generate measurable endpoints for future use. Methods Clinical data from the Oxford University Hospitals real world cohort were analysed. Oxford patient-reported Simple Clinical Colitis Activity Index (SCCAI) scores (including bowel urgency scale 0-3) were extracted from the TrueColours-IBD remote monitoring platform [2], which includes 2,186 patients with UC. Contemporaneous routinely scored endoscopic (UCEIS) and histological (Nancy index) activity were extracted from medical records. Molecular RNA-sequencing (RNAseq) signatures were generated from diagnostic biopsies. Results Overall, bowel urgency showed weak-to-moderate correlations (Spearman correlation coefficient <0.4) with clinical laboratory (CRP, albumin and haemoglobin), endoscopic (UCEIS) and histological (Nancy histologic index) measures of disease activity. By contrast, bowel urgency correlated moderately-to-strongly (Spearman correlation coefficient >0.6) with most other patient-reported symptom measures (bowel frequency, general wellbeing and total SCCAI). Based on bulk RNAseq profiling from biopsies of patients with UC obtained within two weeks of a reported SCCAI, we defined molecular signatures of cellular contractility, lymphocyte activation, B cell immunity and chemotaxis. Molecular signatures that most strongly correlated with objective markers of inflammation (such as endoscopic and histological measures) were also correlated with reported bowel urgency [FIGURE 1]. However, there were notable cases of discordance between urgency and objective measures of inflammation [FIGURE 2]. Conclusion At a cohort level, bowel urgency correlates with laboratory, endoscopic and histological measures of UC, but most strongly correlates with other patient reported symptoms indicative of disease activity. In corroboration, at a molecular RNA-level, bowel urgency similarly correlates with endoscopic and histologic markers of disease severity. However, on a patient-level there is a notable subset of patients with UC who demonstrate discordance between patient-reported urgency and objective markers of inflammation. Together, this suggests the presence of both overlapping and non-overlapping mechanisms of the symptomatic experience of urgency and bowel inflammation, which we are dissecting at a cellular level.

P0392 Prospective endoscopy of pan-enteric mucosal, transmural and biochemical dynamics in the first year of biological treatment in Crohn’s disease - a prospective MILESTONE study

Abstract Background Crohn’s disease (CD) complications affect 25% of patients at diagnosis and may progress to over 70% within ten years, often evolving into more complex forms. Controlling inflammation is essential to prevent disease progression, with biologics playing a central role. Video capsule endoscopy (VCE) and intestinal ultrasound (IUS) have proven effective in monitoring CD and predicting future complications. However, prospective data on pan-enteric mucosal inflammation and transmural healing in CD remain limited. Methods This prospective observational study included patients with CD who started on first-line biologics. Patients were followed at baseline, 14 weeks, and 52 weeks with assessments including CD Activity Index (CDAI), C-reactive protein (CRP), fecal calprotectin (FCP), pan-enteric VCE after confirming small-bowel patency via patency capsule (PC) ingestion, and IUS. The primary outcome was the continuation of biologic therapy after one year. Biochemical, endoscopic, and ultrasonographic remission were defined as follows: FCP<150 µg/g, Lewis score (LS)<135 or Eliakim score (ES)<4, and terminal ileum-bowel wall thickness (TI-BWT)<3 mm. Results Seventy-eight patients were screened, with 59 enrolled (median age: 30 [23-43] years; male: 31/59 [52%]; B2/3 disease phenotype: 12/59 [20.3%]), and 19 excluded (Figure, A). The patients started vedolizumab (21/59, 35%), infliximab (11/59, 19%), adalimumab (24/59, 41%) and ustekinumab (3/59, 5%). Eight patients were dropped out before the 14-week time point (Figure, A). At 52 weeks, 34/59 (58%) patients continued their biologics. Among patients with abnormal baseline biochemical, endoscopic, and ultrasonographic measures, 11/42 (26.2%) achieved biochemical normalization, 7/52 (13.5%) achieved small-bowel mucosal healing (MH), 6/38 (15.8%) achieved pan-enteric MH, and 8/28 (28.6%) achieved transmural healing at 14 weeks (Figure, B). Seventeen patients discontinued the study between the 14-week and 52-week time points (Figure, A). At 52 weeks, 17/42 (40.5%) of patients achieved biochemical normalization, 9/52 (17.3%) achieved small-bowel MH, 12/38 (31.6%) achieved pan-enteric MH, and 10/28 (35.7%) achieved transmural healing (Figure, B).All median study indices significantly improved during follow-up: CDAI: 103→64→63 (p=0.08); CRP (mg/dL): 6.6→5.0→4.1 (p=0.016); FCP (μg/g): 678→190→101 (p=0.009); LS: 750→225→225 (p<0.001); ES: 11→4→2 (p<0.001); TI-BWT (mm): 3.8→ 3.3→2.3 (p<0.001) (Figure, C). Conclusion First-line biologics significantly improve pan-enteric MH rates, along with clinical, biochemical, and ultrasonographic indices, in patients with CD over one year, with more than half of patients remaining on therapy during this period.

Endoscopic size measurement of colorectal polyps: a systematic review of techniques.

Accurate size measurement of colorectal polyps is critical for clinical decision making and patient management. This systematic review aimed to evaluate the current techniques used for colonic polyp measurement to improve the reliability of size estimations in routine practice.A comprehensive literature search was conducted across PubMed, EMBASE, and MEDLINE to identify studies relevant to size measurement techniques published between 1980 and March 2024. The primary outcome was the accuracy of polyp sizing techniques used during colonoscopy.61 studies were included with 34 focusing on unassisted and assisted endoscopic visual estimation and 27 on computer-based tools. There was significant variability in visual size estimation among endoscopists. The most accurate techniques identified were computer-based systems, such as virtual scale endoscopes (VSE) and artificial intelligence (AI)-based systems. The least accurate techniques were visual or snare-based polyp size estimation. VSE assists endoscopists by providing an adaptive scale for real-time, direct, in vivo polyp measurements, while AI systems offer size measurements independent of the endoscopist's subjective judgment.This review highlights the need for standardized, accurate, and accessible techniques to optimize sizing accuracy during endoscopic procedures. There is no consensus on a gold standard for measuring polyps during colonoscopy. While biopsy forceps, snare, and graduated devices can improve the accuracy of visual size estimation, their clinical implementation is limited by practical, time, and cost challenges. Computer-based techniques will likely offer improved accuracy of polyp sizing in the near future.

Clinical Trial: Safety and Efficacy of a Novel Oesophageal Delivery System for Topical Corticosteroids Versus Placebo in the Treatment of Eosinophilic Oesophagitis.

EsoCap is a thin mucoadhesive film designed to target the oesophageal mucosa. The device loaded with mometasone furoate (ESO-101) is under investigation for the treatment of eosinophilic oesophagitis (EoE). To evaluate the efficacy, safety and tolerability of ESO-101 in patients with active EoE. We conducted a randomised, placebo-controlled, phase 2, proof-of-concept trial at 14 European sites in adults with EoE. Participants received placebo, uncoated EsoCap (n = 15), or EsoCap loaded with 800 μg of mometasone furoate (n = 28) once daily during 28 days. The primary outcome was the absolute change in the peak eosinophil count; secondary outcomes were histologic, clinical and endoscopic measures. Treatment with ESO-101 resulted in reduction (mean ± SD) of 49.1 ± 88.4 eosinophils/high-power field from baseline, compared with 6.6 ± 65.1 with placebo (p = 0.03). With ESO-101, 48% and 44% of patients achieved < 15 and < 6 eosinophils/high-power field, respectively; these were 0% with placebo. EoE Endoscopic Reference Score reduced significantly in patients treated with ESO-101. In contrast, dysphagia and odynophagia severity decreased similarly in both groups. There were no serious treatment-emergent adverse events. Mean serum cortisol did not change significantly throughout the trial. Notably, no oropharyngeal or oesophageal candidiasis was documented. The device was well tolerated. ESO-101 was superior to placebo in reducing oesophageal eosinophilia. The device was safe and well tolerated in adults with EoE, supporting the continued development of ESO-101 for the treatment of EoE (Trials.gov No.: NCT04849390; Eu-CT No.: 2020-000082-16).

Meta-Analysis: Evaluating Placebo Rates Across Outcomes in Eosinophilic Oesophagitis Randomised Controlled Trials.

High placebo responses have limited drug development in eosinophilic oesophagitis. The optimal configuration of trial outcomes is uncertain. To inform more efficient future trial designs, to characterise clinical, endoscopic and histologic placebo responses in eosinophilic oesophagitis randomised controlled trials (RCTs). We updated a Cochrane systematic review and meta-analysis, searching multiple databases to January 1, 2024, to identify placebo-controlled RCTs evaluating medical therapies for patients with eosinophilic oesophagitis. The primary outcome was the pooled proportion of study-defined clinical, endoscopic and histologic responders and remitters randomised to placebo, using an intention-to-treat approach and random-effects model. Sources of heterogeneity were explored using meta-regression. We included 25 RCTs. The pooled proportion of clinical response was 41.0% [95% CI: 29.7%-52.8%] with substantial heterogeneity (I2 = 74.9%). On meta-regression, older age and a higher probability of being randomised to placebo reduced the likelihood of clinical response to placebo. The pooled proportion of histologic remission defined as a peak eosinophil count [PEC] ≤ 6 eosinophils per high power field [HPF] or ≤ 1 eosinophil/HPF was 4.3% [95% CI: 2.6%-6.2%] (I2 = 23.6%) and 1.3% [95% CI: 0.5%-2.5%] (I2 = 0%), respectively. The standardised mean difference in the Eosinophilic Oesophagitis Endoscopic Reference Score to placebo was -0.25 [95% CI: -0.41, -0.10]. Over 40% of patients in eosinophilic oesophagitis trials respond clinically to placebo, and this is associated with trial design factors such as randomisation ratio and trial population. Objective endoscopic and histologic measures are associated with very low placebo responses.

Predictive accuracy of fecal calprotectin for histologic remission in ulcerative colitis.

Accurate assessment of disease activity is crucial for effective management and treatment of ulcerative colitis (UC). This study evaluated the correlation between clinical, endoscopic, and histologic measures of disease activity in UC. Clinical, biochemical, endoscopic, and histologic disease activity was studied in 347 patients with UC. Agreements among various histologic classification systems, namely the Geboes Score (GS), Continuous GS, Nancy Index (NI), and Robarts Histopathology Index (RHI), were analyzed. The predictive accuracy of fecal calprotectin (FC) for endoscopic and histologic remission was assessed. We demonstrate a fair to moderate correlation between clinical, endoscopic, and histologic measures of disease activity in UC. There was a robust concordance among GS, Continuous GS, NI, and RHI in distinguishing between patients in histologic remission or activity. The NI detected 75% of patients who met the remission criteria according to the RHI, whereas the RHI identified all patients in remission as defined by the NI. FC levels below 150 μg/g had >70% accuracy in predicting endoscopic remission. FC levels below 150 μg/g showed ≥80% accuracy, and FC levels below 100 μg/g demonstrated ≥ 85% accuracy in predicting histologic remission, regardless of the scoring index applied. Elevated FC levels were associated with both acute and chronic inflammatory infiltrates in biopsy samples. FC is a reliable predictor of histologic remission, with higher accuracy at lower thresholds. The GS, Continuous GS, NI, and RHI demonstrate comparable performance. FC could help stratify patients' need for colonoscopy for the assessment of endoscopic and histologic remission.

Responsiveness of different disease activity indices in moderate-to-severe ulcerative colitis.

Clinical, endoscopic, histological, and composite instruments are currently used to measure disease activity in patients with ulcerative colitis (UC). We compared the responsiveness of the Mayo Clinic score (MCS), modified MCS (mMS; excluding physician global assessment), partial MCS (pMS; MCS without endoscopic subscore), Robart's Histopathology Index (RHI), and UC-100 score to change after ustekinumab treatment in patients with moderately to severely active UC. Post hoc analysis of the phase 3UNIFI induction trial (ClinicalTrials.gov: NCT02407236) was conducted. Participants with moderately to severely active UC were randomized to receive ustekinumab or placebo. Treatment assignment was the criterion to assess responsiveness, which was quantified using the probability of a treated participant having a larger change in score than a placebo participant, termed the win probability (WinP), and estimated using nonparametric methods. The UC-100 score demonstrated large responsiveness (WinP 0.72 [95% confidence interval: 0.66-0.78]), and the MCS (0.68 [0.62-0.73]), mMS (0.69 [0.63-0.75]), and pMS (0.65 [0.59-0.71]) demonstrated similar effect sizes. Of the component items of the Mayo score, the endoscopic subscore (WinP 0.76 [0.69-0.82]) and the stool frequency subscore (WinP 0.74 [0.69-0.79]) were the most responsive. The Inflammatory Bowel Disease Questionnaire (IBDQ) quality-of-life questionnaire was also responsive (WinP 0.78 [0.72-0.82]). UC disease activity indices are similarly responsive. Depending on the treatment setting, time point of evaluation, and feasibility of measurement, different scores may be used to demonstrate response. These results support the use of mMS as a composite primary endpoint, incorporating both patient-reported and endoscopic outcome measures. The UC-100 score may be more appropriate in settings that also routinely incorporate histological evaluation. There is no funding for this study.

807. A REVISED APPROACH TO THE ESOPHAGOGASTRIC JUNCTION: A MODIFIED SIEWERT CLASSIFICATION

Abstract Background Esophagogastric junction (EGJ) adenocarcinomas are challenging due to their anatomical and histopathological features and treated either as part of the esophagus or stomach cancers. Siewert (S) and Nishi classifications rely on the tumor’s epicenter to guide treatment decisions, which can lead to diagnostic and therapeutic inconsistencies. Moreover, recent studies helped define the optimal extent of lymphadenectomy for EGJ cancers. Here we present our standardized approach to EGJ cancers that integrates these insights, providing a framework to guide clinical decision-making. Methods Our modified classification relies on tumor extent rather than the epicentre, based on endoscopic measurement of the proximal and the distal limits, and the exact location of the EGJ. This approach classifies tumors based on their extent which results into six categories: SI, SI/II, SII, SII/III, SIII, and SI/II/III. Lower esophageal tumors whose distal limit lies between + 1cm and -2cm are classified as I/II. Cardia tumors whose proximal limit falls between those boundaries are II/III. Tumors that span more cephalad than + 1cm and more distally than – 2cm, are I/II/III. For Siewert I, I/II and II tumors, surgical management depends on the extent of esophageal involvement, mainly dictated by the probability of mediastinal basement nodal involvement, as defined by Kurokawa et al (2019). Additionally, a 3-field lymphadenectomy is performed when there is involvement of the cervical or recurrent laryngeal nerve lymph node stations. Results In SI, SI/II, and SI/II/III, with esophageal involvement exceeding 4 cm we favor a transthoracic esophagectomy (TTE) with total thoracic lymphadenectomy. If the involvement is between 1-4 cm, a transhiatal esophagectomy (THE) with lower mediastinal lymphadenectomy is performed. In SII, THE is done for 0-1 cm of involvement; absence of esophageal involvement permits a transhiatal extended total gastrectomy (eTG) with abdominal D2 lymphadenectomy and intra-operative margin status assessment via frozen sections. In SI/II/III and esophageal involvement of more than 4 cm, TTE is required; for esophageal involvement of 1-4 cm, we perform a THE and total gastrectomy with abdominal D2 lymphadenectomy based on distal margin findings. Conclusion This proposed modification to the classification of EGJ adenocarcinomas introduces a comprehensive framework that is tailored to the extent of tumor involvement. By addressing the limitations of existing systems and incorporating current insights, this updated classification aims to improve patient categorization and standardize treatment protocols, potentially leading to enhanced clinical outcomes.

Bleeding in liver diseases

Bleeding events are feared complications in patients with advanced liver diseases and are associated with morbidity and mortality. In this context, gastrointestinal bleeding, particularly upper gastrointestinal bleeding, has a special clinical importance. In addition to endoscopic measures for hemostasis, reducing portal pressure in particular is akey component of treatment. Although the standard coagulation parameters are often altered in patients with liver diseases, optimizing coagulation plays asecondary role. Typically, abundle of measures are employed in patients with portal hypertensive bleeding, which nowadays in most cases can halt the bleeding and stabilize the situation. The measures include endoscopy, antibiotic treatment, vasopressor treatment and, if necessary, shunt placement (transjugular intrahepatic portosystemic shunt).

Using Diet to Treat Inflammatory Bowel Disease: A Systematic Review.

To review the efficacy of various dietary interventions for induction of clinical remission in inflammatory bowel disease (IBD) and provide healthcare providers with a practical reference for recommending suitable diets for managing patients with IBD. PubMed, Medline(R), and Cochrane were searched from inception up to February 17, 2023 to identify all studies reporting information on using diet to treat IBD. Studies investigating the role of dietary interventions on adult patients with a confirmed diagnosis of active IBD for improvement or remission of IBD symptoms were rigorously considered. Sample meal plans, with a list of included and excluded foods, were also generated in order to provide clinicians with practical tools for advising patients on dietary intake. Eleven included studies provided data on 10 distinct diets: autoimmune protocol diet, high fiber diet, 4-SURE diet, highly restricted diet, McMaster elimination diet for Crohn's disease, specific carbohydrate diet, Mediterranean diet, Crohn's disease exclusion diet, individualized elimination diet, and the food-specific IgG4-guided exclusion diet. A total of 9 studies provided data on clinical remission. Many of these diets share common elements, such as an initial elimination phase with subsequent reintroduction of dietary components, inclusion of whole foods, and exclusion of highly or ultra-processed foods. Currently, there is limited evidence to support the use of specific diets to treat adult patients with mildly to moderately active IBD. Larger, randomized studies with standardized methodologies and outcome measures, rigorous adherence assessment, and an emphasis on endoscopic assessment outcome measures are required to validate most diets that have been studied for IBD. The included sample diet plans and dietary recommendations may prove helpful in the interim as part of a holistic strategy to manage patients with IBD.

Patient and procedural factors associated with true histology rates in patients undergoing colonoscopy with computer-aided detection of polyps

Computer-aided detection (CADe) devices have been shown to increase adenoma detection rates and adenomas per colonoscopy compared to standard colonoscopies. Questions remain about whether CADe colonoscopies are mainly increasing the detection of small, nonneoplastic lesions or if they are detecting more pathologically meaningful polyps. In this analysis, we compare the true histology rate (defined as polyps with confirmation of clinically relevant histopathology) of CADe-identified polyps with polyps identified during standard colonoscopies. Using data from the SKOUT trial, we compared the true histology rate (THR) between CADe and standard colonoscopies. We also conducted a subgroup analysis by patient, procedural, and endoscopist factors. To account for multiple testing of comparisons, we used the false discovery rate. A total of 1423 participants were included (CADe, n= 714; standard, n= 709). Overall, THR was similar between the CADe and standard colonoscopy arms for adenomas, sessile serrated lesions, and large hyperplastic polyps. Higher THR with CADe colonoscopy was observed in some subgroups for adenomas. Endoscopists with 11 to 20 years of experience and procedures occurring after 12 pm had significantly higher adenoma THRs in the CADe cohort. Patients younger than 65 years, male patients, and procedures with a withdrawal time of≥8 minutes had borderline significance in the CADe device adenoma THR subgroup. CADe colonoscopies may hold the key to improving endoscopic quality measures, provided that the polyps identified by the CADe device are those of clinical relevance. Although the benefit and significance in the CADe group were demonstrated in this analysis, further research is warranted to ensure that the true histology is maintained when applied in real-world applications.

Dupilumab for Eosinophilic Esophagitis in Patients 1 to 11 Years of Age

BackgroundDupilumab is a human monoclonal antibody that blocks interleukin-4 and interleukin-13 pathways and has shown efficacy in five different atopic diseases marked by type 2 inflammation, including eosinophilic esophagitis in adults and adolescents.MethodsIn this phase 3 trial, we randomly assigned, in a 2:2:1:1 ratio, patients 1 to 11 years of age with active eosinophilic esophagitis who had had no response to proton-pump inhibitors to 16 weeks of a higher-exposure or lower-exposure subcutaneous dupilumab regimen or to placebo (two groups) (Part A). At the end of Part A, eligible patients in each dupilumab group continued the same regimen and those in the placebo groups were assigned to higher-exposure or lower-exposure dupilumab for 36 weeks (Part B). At each level of exposure, dupilumab was administered in one of four doses tiered according to baseline body weight. The primary end point was histologic remission (peak esophageal intraepithelial eosinophil count, ≤6 per high-power field) at week 16. Key secondary end points were tested hierarchically.ResultsIn Part A, histologic remission occurred in 25 of the 37 patients (68%) in the higher-exposure group, in 18 of the 31 patients (58%) in the lower-exposure group, and in 1 of the 34 patients (3%) in the placebo group (difference between the higher-exposure regimen and placebo, 65 percentage points [95% confidence interval {CI}, 48 to 81; P<0.001]; difference between the lower-exposure regimen and placebo, 55 percentage points [95% CI, 37 to 73; P<0.001]). The higher-exposure dupilumab regimen led to significant improvements in histologic, endoscopic, and transcriptomic measures as compared with placebo. The improvements in histologic, endoscopic, and transcriptomic measures between baseline and week 52 in all the patients were generally similar to the improvements between baseline and week 16 in the patients who received dupilumab in Part A. In Part A, the incidence of coronavirus disease 2019, nausea, injection-site pain, and headache was at least 10 percentage points higher among the patients who received dupilumab (at either dose) than among those who received placebo. Serious adverse events were reported in 3 patients who received dupilumab during Part A and in 6 patients overall during Part B.ConclusionsDupilumab resulted in histologic remission in a significantly higher percentage of children with eosinophilic esophagitis than placebo. The higher-exposure dupilumab regimen also led to improvements in measures of key secondary end points as compared with placebo. (Funded by Sanofi and Regeneron Pharmaceuticals; EoE KIDS ClinicalTrials.gov number, NCT04394351.)

Artificial Intelligence-assisted Video Colonoscopy for Disease Monitoring of Ulcerative Colitis: A Prospective Study.

The Mayo endoscopic subscore [MES] is the most popular endoscopic disease activity measure of ulcerative colitis [UC]. Artificial intelligence [AI]-assisted colonoscopy is expected to reduce diagnostic variability among endoscopists. However, no study has been conducted to ascertain whether AI-based MES assignments can help predict clinical relapse, nor has AI been verified to improve the diagnostic performance of non-specialists. This open-label, prospective cohort study enrolled 110 patients with UC in clinical remission. The AI algorithm was developed using 74 713 images from 898 patients who underwent colonoscopy at three centres. Patients were followed up after colonoscopy for 12 months, and clinical relapse was defined as a partial Mayo score > 2. A multi-video, multi-reader analysis involving 124 videos was conducted to determine whether the AI system reduced the diagnostic variability among six non-specialists. The clinical relapse rate for patients with AI-based MES = 1 (24.5% [12/49]) was significantly higher [log-rank test, p = 0.01] than that for patients with AI-based MES = 0 (3.2% [1/31]). Relapse occurred during the 12-month follow-up period in 16.2% [13/80] of patients with AI-based MES = 0 or 1 and 50.0% [10/20] of those with AI-based MES = 2 or 3 [log-rank test, p = 0.03]. Using AI resulted in better inter- and intra-observer reproducibility than endoscopists alone. Colonoscopy using the AI-based MES system can stratify the risk of clinical relapse in patients with UC and improve the diagnostic performance of non-specialists.

Reliability and Responsiveness of Clinical and Endoscopic Outcome Measures in Crohn's Disease.

Regulatory guidance for Crohn's disease trials recommends coprimary efficacy end points that evaluate both symptoms and mucosal inflammation. We aimed to characterize the operating properties of commonly used disease activity assessments alone and in combination. Endoscopic and clinical data were available for 129 participants from the Study of Biologic and Immunomodulator Naïve Patients in Crohn's Disease trial. Readers scored the Simple Endoscopic Score for Crohn's Disease and the Crohn's Disease Endoscopic Index of Severity using standardized conventions. Index reliability was determined using intraclass correlation coefficients. Index responsiveness was assessed using standardized effect sizes based upon treatment assignment. Outcomes were evaluated for optimal sensitivity to treatment effect. Substantial inter-rater reliability was observed when the Simple Endoscopic Score for Crohn's Disease and Crohn's Disease Endoscopic Index of Severity were used as continuous measures (intraclass correlation coefficient, 0.64; 95% confidence interval [CI], 0.50-0.73; and 0.62 95% CI, 0.36-0.77) compared with moderate reliability when dichotomized (0.46; 95% CI, 0.26-0.65; and 0.51; 95% CI, 0.00-0.78). The Simple Endoscopic Score for Crohn's Disease, Crohn's Disease Endoscopic Index of Severity, patient-reported outcome-2, and Crohn's Disease Activity Index were similarly responsive (standardized effect size, 0.43, 95% CI, 0.05-0.81; 0.38, 95% CI, 0.0-0.76; 0.53, 95% CI, 0.15-0.91). A composite outcome of Crohn's Disease Activity Index score <150 and Crohn's Disease Endoscopic Index of Severity score <6 was most sensitive to treatment effect (28.9%; 95% CI, 11.0%-46.8%; P = .003). Endoscopic indices were more reliable as continuous measures. Composite outcomes including endoscopy improved sensitivity to treatment effect.

Calibration for endoscopic 3D shape measurement with cone beam projection

We demonstrate a calibration method for endoscopic three-dimensional shape measurement with cone beam projection. In this method, changes in the shape of the optical sectioning profiles are quantified and fitted while scanning a calibration board in the depth direction, using a cubic function. In accuracy tests using a flat plate and a ring reference gauge, the proposed method obtains an accuracy of 0.02 mm in the depth dimension and 0.09 mm in the radial dimension. These results represent 88% and 55% improvements compared to previous analysis. For medical applications, an ear examination simulator was employed, and our measurement results were compared to ground truth data obtained by microfocus X-ray computed tomography. The surface deviation of our method relative to the ground truth data was ±0.36mm during manual operation. A comparison of the measurement results before and after calibration revealed an improvement in the peak agreement with the ground truth data, with the deviation shifting from 0.2 mm to −0.05mm. Our strategy achieves a digital transformation of 3D endoscopy, which would benefit a number of medical fields.

Cirrhosis and Portal Hypertension Worsen Bowel Preparation for Screening Colonoscopy.

Colonoscopy is a diagnostic and therapeutic procedure that reduces colorectal cancer incidence and mortality but requires adequate bowel cleansing for high-quality examination. Past studies have suggested cirrhosis as a risk factor for worse bowel preparation. We carried out a match-controlled retrospective study evaluating patients with and without cirrhosis who underwent outpatient screening colonoscopies to assess the effect of cirrhosis and portal hypertension complications on preparation quality and endoscopic measures. We also did a subgroup analysis excluding patients with obesity. We examined 1464 patients with cirrhosis and matched controls. Cirrhotic patients had lower mean Boston Bowel Preparation Scale (BBPS) scores and slower cecal intubation times. We found a single point increase in the Model for End-stage Liver Disease (MELD) score, as well as ascites, hepatic encephalopathy, and variceal hemorrhage were all associated with a longer cecal intubation time. Subgroup analysis excluding patients with obesity again found a significantly lower BBPS score and longer cecal intubation time while also finding a 24% drop in polyp detection. Patients with cirrhosis have worse BBPS scores and longer cecal intubation times. Nonobese cirrhotic patients additionally have a lower polyp detection rate. Portal hypertension complications were associated with worsened preparation quality and longer cecal intubation times. Each incremental increase in MELD score lengthened cecal intubation time. These findings support a more aggressive bowel preparation strategy for patients with cirrhosis, especially patients with severe disease or portal hypertension complications.

Operating Properties of Disease Activity Indices in Pediatric Inflammatory Bowel Disease: A Systematic Review.

Accurate, reliable, and responsive disease activity indices are important to streamline drug approval and treatment modalities for pediatric inflammatory bowel disease (pIBD). We aimed to identify all scoring indices used in pIBD randomized controlled trials (RCTs) and to evaluate their operating properties. MEDLINE, EMBASE, and CENTRAL were searched on December 6, 2022, to identify studies evaluating clinical, endoscopic, imaging, or patient-reported outcome measures (PROMs) in pIBD including Crohn's disease (CD) and ulcerative colitis (UC). Validity, reliability, responsiveness, and feasibility were summarized. Seventy RCTs evaluating pIBD indices were identified. Forty-one studies reported on the operating properties of 14 eligible indices (n = 9 CD, n = 5 UC). The Pediatric Crohn's Disease Activity Index (PCDAI) varied widely in terms of validity and reliability and was less feasible overall. In contrast, the Mucosal Inflammation Noninvasive Index, which includes fecal calprotectin, had better operating properties than the PCDAI. The Simplified Endoscopic Mucosal Assessment of Crohn's Disease appears more feasible and had similar operating properties than the longer Simple Endoscopic Score for Crohn's Disease. The Pediatric Ulcerative Colitis Activity Index was feasible, valid, and reliable, but responsiveness needs to be evaluated further. The Endoscopic Mayo score and the Ulcerative Colitis Endoscopic Index of Severity were reliable, but validity and responsiveness need to be evaluated further. Imaging and PROMs/quality of life indices need further evaluation. The operating properties of pIBD clinical trial end points varied widely. These results highlight the need for further validation and development of novel indices.

Prognosis Analysis of Additional Surgical Treatment for High-Risk T1 Colorectal Cancer Patients After Endoscopic Resection

To analyze the effect of additional surgery on the survival and prognosis of high-risk T1 colorectal cancer patients who have undergone endoscopic resection. The clinical data of patients with high-risk T1 colorectal cancer were retrospectively collected. The patients were divided into the endoscopic resection (ER) plus additional surgical resection (SR) group, or the ER+SR group, and the ER group according to whether additional SR were performed after ER. Baseline data of the patients and information on the location, size, and postoperative pathology of the lesions were collected. Patient survival-related information was obtained through the medical record system and patient follow-up. The primary outcome indicators were the overall survival and the colorectal cancer-specific survival. Univariate Cox regression analysis was used to screen survival-related risk factors and hazard ratio (HR) was calculated. Multivariate Cox regression analysis was used to analyze the independent influencing factors. The data of 109 patients with T1 high-risk colorectal cancer were collected, with 52 patients in the ER group and 57 patients in the ER+SR group. The mean age of patients in the ER group was higher than that in the ER+SR group (65.21 years old vs. 60.54 years old, P=0.035), and the median endoscopic measurement of the size of lesions in the ER group was slightly lower than that in the ER+SR group (2.00 cm vs. 2.50 cm, P=0.026). The median follow-up time was 30.00 months, with the maximum follow-up time being 119 months, in the ER+SR group and there were 4 patients deaths, including one colorectal cancer-related death. Whereas the median follow-up time in the ER group was 28.50 months, with the maximum follow-up time being 78.00 months, and there were 4 patient deaths, including one caused by colorectal cancer. The overall 5-year cumulative survival rates in the ER+SR group and the ER group were 94.44% and 81.65%, respectively, and the cancer-specific 5-year cumulative survival rates in the ER+SR group and the ER group were 97.18% and 98.06%, respectively. The Kaplan-Meier analysis showed no significant difference in the overall cumulative survival or cancer-specific cumulative survival between the ER+SR and the ER groups. Univariate Cox regression analysis showed that age and the number of reviews were the risk factors of overall survival (HR=1.16 and HR=0.27, respectively), with age identified as an independent risk factor of overall survival in the multivariate Cox regression analysis (HR=1.10, P=0.045). For T1 colorectal cancer patients with high risk factors after ER, factors such as patient age and their personal treatment decisions should not be overlooked. In clinical practice, additional caution should be exercised in decision-making concerning additional surgery.

Enhancing endoscopic measurement: validating a quantitative method for polyp size and location estimation in upper gastrointestinal endoscopy

BackgroundAccurate measurement of polyps size is crucial in predicting malignancy, planning relevant intervention strategies and surveillance schedules. Endoscopists’ visual estimations can lack precision. This study builds on our prior research, with the aim to evaluate a recently developed quantitative method to measure the polyp size and location accurately during a simulated endoscopy session.MethodsThe quantitative method merges information about endoscopic positions obtained from an electromagnetic tracking sensor, with corresponding points on the images of the segmented polyp border. This yields real-scale 3D coordinates of the border of the polyp. By utilising the sensor, positions of any anatomical landmarks are attainable, enabling the estimation of a polyp’s location relative to them. To verify the method’s reliability and accuracy, simulated endoscopies were conducted in pig stomachs, where polyps were artificially created and assessed in a test–retest manner. The polyp measurements were subsequently compared against clipper measurements.ResultsThe average size of the fifteen polyps evaluated was approximately 12 ± 4.3 mm, ranging from 5 to 20 mm. The test–retest reliability, measured by the Intraclass Correlation Coefficient (ICC) for polyp size estimation, demonstrated an absolute agreement of 0.991 (95% CI 0.973–0.997, p < 0.05). Bland & Altman analysis revealed a mean estimation difference of − 0.17 mm (− 2.03%) for polyp size and, a mean difference of − 0.4 mm (− 0.21%) for polyp location. Both differences were statistically non-significant (p > 0.05). When comparing the proposed method with calliper measurements, the Bland & Altman plots showed 95% of size estimation differences between − 1.4 and 1.8 mm (− 13 to 17.4%) which was not significant (p > 0.05).ConclusionsThe proposed method of measurements of polyp size and location was found to be highly accurate, offering great potential for clinical implementation to improve polyp assessment. This level of performance represents a notable improvement over visual estimation technique used in clinical practice.

A156 INCIDENCE OF MALIGNANT GASTRIC OUTLET OBSTRUCTION IN PATIENTS WITH PANCREATIC CANCER UNDERGOING FOLFIRINOX THERAPY

Abstract Background Malignant gastric outlet obstruction is a morbid complication of pancreatic cancer. There is currently a lack of epidemiology data characterizing its incidence and outcomes in patients with unresectable pancreatic head cancer undergoing chemotherapy with leucovorin, fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX). Determining the incidence of MGOO in this context is crucial for developing effective management strategies. Aims We aim to ascertain the incidence of MGOO in patients with pancreatic cancer treated with FOLFIRINOX. Secondary objectives include evaluating the clinical outcomes of MGOO. The primary endpoint was the rate of malignant gastric outlet obstruction, defined as clinical evidence of MGOO confirmed with axial imaging and/or endoscopy. Secondary endpoints included the length of hospitalization for MGOO and the rate of successful endoscopic or surgical management. Methods This was a retrospective, single-center study including patients with pancreatic head cancer treated with FOLFIRINOX between January 1, 2017, and December 31, 2022, who did not undergo surgical resection. Patients were excluded if they had pancreatic cancer located in the neck, body, and/or tail of the pancreas, had predominantly cystic cancer, had an oncological resection, had a prophylactic surgical gastrojejunostomy, or had metastatic cancer to the pancreas. Results Overall, 44 patients with pancreatic head cancer (40.90% female, mean age 59.3 ± 8.5 years) were included. There was no statistically significant difference in tumor staging between MGOO and No-MGOO patients: overall, 6.8% borderline, 40.9% metastatic, and 52.3% locally advanced. The incidence of MGOO in patients with pancreatic head cancer was 36.36%. Patients who never developed MGOO experienced significantly shorter unplanned hospitalizations (mean ± SD: 20.8 ± 18.30 days) compared to those with MGOO (mean ± SD: 50.33 ± 41.22 days; p = 0.0175). The mean number of FOLFIRINOX cycles received was 7.2 (±5.43) for patients without MGOO and 8.1 (±5.81) for patients with MGOO (p = 0.6152). Among patients with MGOO (n=12), management strategies included EUS-guided gastrojejunostomy (43.75%), duodenal stent placement (31.25%), and medical management (25%). Conclusions Our contemporary data suggest a high rate of MGOO (36%) in patients with advanced pancreatic head cancer undergoing FOLFIRINOX treatment. The development of MGOO was associated with longer total hospitalization when compared to patients who never developed MGOO. Our study underscores the significant negative impact of MGOO with further research needed to elucidate better management strategies including better endoscopic or surgical prophylactic measures. Funding Agencies CIHR