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.

Expert endoscopist assessment of colorectal polyp size using virtual scale endoscopy, visual or snare-based estimation: a prospective video-based study.

BACKGROUND AND AIMS: Accurate polyp size estimation during colonoscopy has an impact on clinical decision-making. A laser-based virtual scale endoscope (VSE) is available to allow measuring polyp size using a virtual adaptive scale. This study evaluates video-based polyp size measurement accuracy among expert endoscopists using either VSE or visual assessment (VA) with either snare as reference size or without any reference size information. METHODS: A prospective, video-based study was conducted with 10 expert endoscopists. Video sequences from 90 polyps with known reference size (fresh specimen measured using calipers) were distributed on three different slide sets so that each slide set showed the same polyp only once with either VSE, VA or snare-based information. A slide set was randomly assigned to each endoscopist. Endoscopists were asked to provide size estimation based on video review. RESULTS: Relative accuracies for VSE, VA, and snare-based estimation were 75.1% (95% CI [71.6-78.5]), 65.0% (95% CI [59.5-70.4]) and 62.0% (95% CI [54.8-69.0]), respectively. VSE yielded significantly higher relative accuracy compared to VA (p = 0.002) and to snare (p = 0.001). A significantly lower percentage of polyps 1-5 mm were misclassified as >5 mm using VSE versus VA and snare (6.52% vs. 19.6% and 17.5%, p = 0.004) and a significantly lower percentage of polyps >5 mm were misclassified as 1-5 mm using VSE versus VA and snare (11.4% vs. 31.9% and 14.9%, p = 0.038). CONCLUSIONS: Endoscopists estimate polyp size with the highest accuracy when virtual adaptive scale information is displayed. Using a snare to assist sizing did not improve measurement accuracy compared to displaying visual information alone.

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).

Local recurrence rates after resection of large colorectal serrated lesions with or without margin thermal ablation.

INTRODUCTION: Serrated lesions (SLs) including traditional serrated adenomas (TSA), large hyperplastic polyps (HP) and sessile serrated lesions (SSLs) are associated with high incomplete resection rates. Margin ablation combined with EMR (EMR-T) has become routine to reduce local recurrence while cold snare polypectomy (CSP) is becoming recognized as equally effective for large SLs. Our aim was to evaluate local recurrence rates (LRR) and the use of margin ablation in preventing recurrence in a retrospective cohort study. METHODS: Patients undergoing resection of ≥15 mm colorectal SLs from 2010-2022 were identified through a pathology database and electronic medical records search. Hereditary CRC syndromes, first follow-up > 18 months or no follow-up, surgical resection were excluded. Primary outcome was LRRs (either histologic or visual) during the first 18-month follow-up. Secondary outcomes were LRRs according to size, and resection technique. RESULTS: 191 polyps in 170 patients were resected (59.8% women; mean age, 65 years). The mean size of polyps was 22.4 mm, with 107 (56.0%) ≥20 mm. 99 polyps were resected with EMR, 39 with EMR-T, and 26 with CSP. Mean first surveillance was 8.2 mo. Overall LRR was 18.8% (36/191) (16.8% for ≥20 mm, 17.9% for ≥30 mm). LRR was significantly lower after EMR-T when compared with EMR (5.1% vs. 23.2%; p = 0.013) or CSP (5.1% vs. 23.1%; p = 0.031). There was no difference in LRR between EMR without margin ablation and CSP (p = 0.987). CONCLUSION: The local recurrence rate for SLs ≥15 mm is high with 18.8% overall recurrence. EMR with thermal ablation of the margins is superior to both no ablation and CSP in reducing LRRs.

Measuring Size of Colorectal Polyps Using a Virtual Scale Endoscope or Visual Assessment: A Randomized Controlled Trial.

INTRODUCTION: This study aimed to compare the accuracy of polyp size measurements using a virtual scale endoscope (VSE) with an integrated laser-based adaptive scale function and visual assessment (VA) during colonoscopies. METHODS: We conducted a single-blinded, prospective randomized controlled trial. Eligible patients (aged 45-80 years) undergoing screening, surveillance, or diagnostic colonoscopies were randomly assigned (1:1) into 2 groups. In the intervention group, all detected polyps were measured for size using VSE; in the control group, all polyps were measured using VA. Size measurements were compared with a reference standard of digital caliper measurement immediately post polypectomy. The primary outcome was the relative accuracy of real-time VSE measurement compared with VA. Secondary outcomes included the mean differences and the correlations between VSE or VA sizes and the reference standard of measurement. RESULTS: Overall, 230 patients were enrolled and randomized. The relative size measurement accuracy of VSE was 84% in 118 polyps, which was significantly higher than that of VA (105 polyps; 68.4%, P < 0.001). VSE resulted in a significantly higher percentage of size measurements within 25% of true size compared with VA (81.4% vs 41%, P < 0.001). VSE had a significantly lower percentage for >5-mm polyps incorrectly sized as 1-5 mm compared with VA (13.5% vs 57.1%; P < 0.001) and a significantly lower percentage for >3-mm polyps incorrectly sized as 1-3 mm compared with VA (11.3% vs 56.5%; P < 0.001). DISCUSSION: VSE significantly improves the size measurement accuracy of colorectal polyps during colonoscopies compared with VA and results in fewer misclassifications at relevant decision-making size thresholds.

Large serrated polyps indicate a greater risk of advanced metachronous colorectal neoplasia than high-grade adenomas.

Background and study aims The risk of developing total metachronous advanced neoplasia (TMAN) in patients with index serrated lesions (SL) or adenoma with high-grade dysplasia (HGD) is unknown. We evaluated this risk in patients with either HGD, SL < 10 mm or SL ≥ 10 mm at index colonoscopy, who underwent surveillance colonoscopies. Patients and methods This retrospective cohort study evaluated all consecutive patients (n = 2477) diagnosed between 2010 and 2019 with colorectal HGD, SLs < 10 mm or SLs ≥ 10 mm. We excluded patients aged < 45 or > 75 years or those who had inflammatory bowel disease, hereditary colorectal cancer (CRC) syndromes, previous or synchronous CRC, or no follow-up colonoscopy. Descriptive variables were compared using analysis of variance or Pearson chi-squared tests. Multivariate Cox regressions were used to compare the risk of TMAN between the HGD, SL < 10 mm and SL ≥ 10 mm groups. Results Overall, 585 patients (mean age 63 years; 55% male; mean follow-up 3.67 years) were included (226 with SLs < 10 mm, 204 with SLs ≥ 10 mm, 155 with HGD). Compared with SLs < 10 mm, patients with HGD did not have a significantly different rate of TMAN (HR=0.75 [0.39-1.44]) and patients with SLs ≥ 10 mm had a higher rate of TMAN (HR=2.08 [1.38-3.15]). Compared with HGD, patients with SLs ≥ 10 mm had a higher rate of TMAN (HR=1.87 [1.04-3.36]). Conclusions The risk for TMAN was higher for patients with SLs ≥ 10 mm than with HGD or SLs < 10 mm. This risk should be considered when planning surveillance intervals for patients diagnosed with large SLs.

Accuracy in Polyp Size Measurement Among Surgeons, Gastroenterologists, Trainees, and Experts: A Prospective Video-Based Study.

INTRODUCTION: Polyp size determination plays an important role in endoscopic decision making and follow-up determination. However, there is a lack of knowledge of endoscopist accuracy for polyp sizing and efficacy of available tools for size measurement. Our aim was to compare the accuracy of visual assessment, snare, forceps, and virtual scale endoscope (VSE) in estimating polyp size among a diverse group of endoscopists. METHODS: We conducted a prospective video-based study. One hundred twenty polyps measured and recorded along with all available measurement tools were randomized to visual assessment, snare, forceps, or VSE group. Eleven endoscopists conducted video-based measurement using the randomized measurement tool. Primary outcome was relative accuracy in polyp size measurement compared with caliper measurement immediately postresection. RESULTS: One thousand three hundred twenty measurements were performed. VSE had statistically significantly higher relative accuracy when compared to forceps (79.3 vs 71.3%; P < 0.0001). Forceps had statistically significantly higher relative accuracy when compared to visual assessment (71.3 vs 63.6%; P = 0.0036). There was no statistically significant difference when comparing visual assessment and snare-based measurements (63.6 vs 62.8%; P = 0.797). Overall, 21.5% of polyps >5 mm were misclassified as ≤5 mm and 17.3% of polyps ≥10 mm were misclassified as <10 mm. VSE had the lowest percentage of polyps >5 mm misclassified as ≤5 mm (2.6%), polyps ≤5 mm misclassified as >5 mm (5.1%), and polyps <10 mm misclassified as ≥10 mm (1.7%). DISCUSSION: Visual size estimation of polyps is inaccurate independently of training level, sex, and specialty. Size measurement accuracy can be improved using forceps and yields the highest relative accuracy when an adaptive scale technology is used.

Incomplete resection rates of 4- to 20-mm non-pedunculated colorectal polyps when using wide-field cold snare resection with routine submucosal injection.

Background and study aims Incomplete resection of 4- to 20-mm colorectal polyps occur frequently (> 10 %), putting patients at risk for post-colonoscopy colorectal cancer. We hypothesized that routine use of wide-field cold snare resection with submucosal injection (CSP-SI) might reduce incomplete resection rates (IRRs). Patients and methods Patients aged 45 to 80 years undergoing elective colonoscopies were enrolled in a prospective clinical study. All 4- to 20-mm non-pedunculated polyps were resected using CSP-SI. Post-polypectomy margin biopsies were obtained to determine IRRs through histopathology assessment. The primary outcome was IRR, defined as remnant polyp tissue found on margin biopsies. Secondary outcomes included technical success and complication rates. Results A total of 429 patients (median age 65 years, 47.1 % female, adenoma detection rate 40 %) with 204 non-pedunculated colorectal polyps 4 to 20 mm removed using CSP-SI were included in the final analysis. CSP-SI was technical successful in 97.5 % (199/204) of cases (5 conversion to hot snare polypectomy). IRR for CSP-SI was 3.8 % (7/183) (95 % confidence interval [CI] 2.7 %-5.5 %). IRR was 1.6 % (2/129), 16 % (4/25), and 3.4 % (1/29) for adenomas, serrated lesions, and hyperplastic polyps respectively. IRR was 2.3 % (2/87), 6.3 % (4/64), 4.0 % (6/151), and 3.1 % (1/32) for polyps 4 to 5 mm, 6 to 9 mm, < 10 mm, and 10 to 20 mm, respectively. There were no CSP-SI-related serious adverse events. Conclusions Use of CSP-SI results in lower IRRs compared to what has previously been reported in the literature for hot or cold snare polypectomy when not using wide-field cold snare resection with submucosal injection. CSP-SI showed an excellent safety and efficacy profile, however comparative studies to CSP without SI are required to confirm these results.

Rates of synchronous advanced neoplasia and colorectal cancer in patients with colonic serrated lesions.

BACKGROUND AND AIMS: Serrated lesions (SL) have been associated with significant risks of developing colorectal cancer (CRC). Data on synchronous findings after SL detection during colonoscopy is limited. Study aim was to evaluate the rate of synchronous advanced neoplasia (S-AN) and synchronous CRC (S-CRC) in colonoscopies where SLs were detected. METHODS: We conducted a retrospective study of screening aged patients 45-74year with colorectal SL (sessile serrated polyp [SSP] or traditional serrated adenoma [TSA]) detected during an elective colonoscopy. Primary outcome was risk of S-AN in patients with SL. Secondary outcomes included risk of S-AN or S-CRC stratified by SL characteristics. RESULTS: The study included 1262 patients with 1649 SLs (1214 with SSPs and 48 with TSAs). 47.2% were female and 22.9% of exams were screening colonoscopies, 48.2% surveillance, 28.9% diagnostic. The overall rates of S-AN and S-CRC were 15.1% and 1.3%, respectively. Presence of SSPs ≥ 10 mm was associated with higher rates of S-AN, (18.1 vs. 12.2%, Odds-Ratio [OR] = 1.61 [95% Confidence Interval [CI] 1.17-2.23], p = 0.004). SSP dysplasia was predictive of S-AN, (30.3 vs 14.1%, OR = 2.68 [95%CI 1.24-5.78], p = 0.012) but not S-CRC. SSP number (≥ 3) and location (proximal) were not predictors of S-AN or S-CRC. CONCLUSION: Patients with SLs are at high-risk of S-AN and S-CRC. Findings of SSPs ≥ 10 mm and SSP dysplasia are associated with high-risk of S-AN. Endoscopists should exercise heightened vigilance for synchronous findings when SLs are detected, especially SSPs ≥ 10 mm or when bowel preparation is suboptimal. Studies contrasting synchronous risk of other polyp types are needed to confirm these results.

Comparing size measurement of colorectal polyps using a novel virtual scale endoscope, endoscopic ruler or forceps: A preclinical randomized trial.

Background and study aims Accurate polyp size measurement is important for guideline conforming choice of polypectomy techniques and subsequent surveillance interval assignments. Some endoscopic tools (biopsy forceps [BF] or endoscopic rulers [ER]) exist to help with visual size estimation. A virtual scale endoscope (VSE) has been developed that allows superimposing a virtual measurement scale during live endoscopies. Our aim was to evaluate the performance of VSE when compared to ER and BF-based measurement. Methods We conducted a preclinical randomized trial to evaluate the relative accuracy of size measurement of simulated colorectal polyps when using: VSE, ER, and BF. Six endoscopists performed 60 measurements randomized at a 1:1:1 ratio using each method. Primary outcome was relative accuracy in polyp size measurement. Secondary outcomes included misclassification of sizes at the 5-, 10-, and 20-mm thresholds. Results A total of 360 measurements were performed. The relative accuracy of BF, ER, and VSE was 78.9 % (95 %CI = 76.2-81.5), 78.4 % (95 %CI = 76.0-80.8), and 82.7 % (95 %CI = 80.8-84.8). VSE had significantly higher accuracy compared to BF ( P  = 0.02) and ER ( P  = 0.006). VSE misclassified a lower percentage of polyps > 5 mm as ≤ 5 mm (9.4 %) compared to BF (15.7 %) and ER (20.9 %). VSE misclassified a lower percentage of ≥ 20 mm polyps as < 20 mm (8.3 %) compared with BF (66.7 %) and ER (75.0 %). Of polyps ≥10mm, 25.6 %, 25.5 %, and 22.5 % were misclassified as <10 mm with ER, BF, and VSE, respectively. Conclusions VSE had significantly higher relative accuracy in measuring polyps compared to ER or BF assisted measurement. VSE improves correct classification of polyps at clinically important size thresholds.

Risk of total metachronous advanced neoplasia at surveillance colonoscopy after detection of serrated lesions: a matched case-cohort study.

BACKGROUND : Serrated lesions are potential colorectal cancer precursors. This study evaluated the presence of total metachronous advanced neoplasia (T-MAN) at follow-up in patients with index serrated lesions compared with a matched cohort without serrated lesions. METHODS : Patients aged 45-74 years with serrated lesions were matched 2:1 by sex, age, synchronous polyps, and timing of index colonoscopy, to patients without serrated lesions. The primary outcome was T-MAN (advanced adenoma or high-risk serrated lesion) at follow-up. Secondary outcomes included presence of T-MAN stratified by synchronous polyps and serrated lesion characteristics. RESULTS : 1425 patients were included (475 patients, 642 serrated lesions; 950 controls; median follow-up 2.9 versus 3.6 years). Patients with serrated lesions had greater risk of T-MAN than those without (hazard ratio [HR] 6.1, 95 %CI 3.9-9.6). Patients with serrated lesions and high-risk adenoma (HRA) had higher risk of T-MAN than those with HRA alone (HR 2.6, 95 %CI 1.4-4.7); similarly, patients with serrated lesions plus low-risk adenoma (LRA) had higher risk than those with LRA alone (HR 7.0, 95 %CI 2.8-18.4), as did patients with serrated lesions without adenoma compared with no adenoma (HR 14.9, 95 %CI 6.5-34.0). Presence of proximal sessile serrated lesion (SSL; HR 9.3, 95 %CI 5.4-15.9), large SSL (HR 17.8, 95 %CI 7.4-43.3), and proximal large SSL (HR 25.0, 95 %CI 8.8-71.3), but not distal SSL, were associated with greater risk for T-MAN. CONCLUSION : Patients with serrated lesions had higher risk for T-MAN regardless of synchronous adenomas. Patients with serrated lesions and HRA, and those with large or proximal SSLs, were at greatest risk.