Effect of Real-Time Computer-Aided Polyp Detection System (ENDO-AID) on Adenoma Detection in Endoscopists-in-Training: A Randomized Trial.

BACKGROUND: The effect of computer-aided polyp detection (CADe) on adenoma detection rate (ADR) among endoscopists-in-training remains unknown. METHODS: We performed a single-blind, parallel-group, randomized controlled trial in Hong Kong between April 2021 and July 2022 (NCT04838951). Eligible subjects undergoing screening/surveillance/diagnostic colonoscopies were randomized 1:1 to receive colonoscopies with CADe (ENDO-AID[OIP-1]) or not (control) during withdrawal. Procedures were performed by endoscopists-in-training with <500 procedures and <3 years' experience. Randomization was stratified by patient age, sex, and endoscopist experience (beginner vs intermediate level, <200 vs 200-500 procedures). Image enhancement and distal attachment devices were disallowed. Subjects with incomplete colonoscopies or inadequate bowel preparation were excluded. Treatment allocation was blinded to outcome assessors. The primary outcome was ADR. Secondary outcomes were ADR for different adenoma sizes and locations, mean number of adenomas, and non-neoplastic resection rate. RESULTS: A total of 386 and 380 subjects were randomized to CADe and control groups, respectively. The overall ADR was significantly higher in the CADe group than in the control group (57.5% vs 44.5%; adjusted relative risk, 1.41; 95% CI, 1.17-1.72; P < .001). The ADRs for <5 mm (40.4% vs 25.0%) and 5- to 10-mm adenomas (36.8% vs 29.2%) were higher in the CADe group. The ADRs were higher in the CADe group in both the right colon (42.0% vs 30.8%) and left colon (34.5% vs 27.6%), but there was no significant difference in advanced ADR. The ADRs were higher in the CADe group among beginner (60.0% vs 41.9%) and intermediate-level (56.5% vs 45.5%) endoscopists. Mean number of adenomas (1.48 vs 0.86) and non-neoplastic resection rate (52.1% vs 35.0%) were higher in the CADe group. CONCLUSIONS: Among endoscopists-in-training, the use of CADe during colonoscopies was associated with increased overall ADR. (ClinicalTrials.gov, Number: NCT04838951).

An Evaluation of Critical Factors for the Cost-Effectiveness of Real-Time Computer-Aided Detection: Sensitivity and Threshold Analyses Using a Microsimulation Model.

BACKGROUND & AIMS: The use of computer-aided detection (CAD) increases the adenoma detection rates (ADRs) during colorectal cancer (CRC) screening/surveillance. This study aimed to evaluate the requirements for CAD to be cost-effective and the impact of CAD on adenoma detection by endoscopists with different ADRs. METHODS: We developed a semi-Markov microsimulation model to compare the effectiveness of traditional colonoscopy (mean ADR, 26%) to colonoscopy with CAD (mean ADR, 37%). CAD was modeled as having a $75 per-procedure cost. Extensive 1-way sensitivity and threshold analysis were performed to vary cost and ADR of CAD. Multiple scenarios evaluated the potential effect of CAD on endoscopists' ADRs. Outcome measures were reported in incremental cost-effectiveness ratios, with a willingness-to-pay threshold of $100,000/quality-adjusted life year. RESULTS: When modeling CAD improved ADR for all endoscopists, the CAD cohort had 79 and 34 fewer lifetime CRC cases and deaths, respectively, per 10,000 persons. This scenario was dominant with a cost savings of $143 and incremental effectiveness of 0.01 quality-adjusted life years. Threshold analysis demonstrated that CAD would be cost-effective up to an additional cost of $579 per colonoscopy, or if it increases ADR from 26% to at least 30%. CAD reduced CRC incidence and mortality when limited to improving ADRs for low-ADR endoscopists (ADR <25%), with 67 fewer CRC cases and 28 CRC deaths per 10,000 persons compared with traditional colonoscopy. CONCLUSIONS: As CAD is implemented clinically, it needs to improve mean ADR from 26% to at least 30% or cost less than $579 per colonoscopy to be cost-effective when compared with traditional colonoscopy. Further studies are needed to understand the impact of CAD when used in community practice.

The Efficacy of Real-time Computer-aided Detection of Colonic Neoplasia in Community Practice: A Pragmatic Randomized Controlled Trial.

BACKGROUND & AIMS: The use of computer-aided detection (CADe) has increased the adenoma detection rates (ADRs) during colorectal cancer (CRC) screening/surveillance in randomized controlled trials (RCTs) but has not shown benefit in real-world implementation studies. We performed a single-center pragmatic RCT to evaluate the impact of real-time CADe on ADRs in colonoscopy performed by community gastroenterologists. METHODS: We enrolled 1100 patients undergoing colonoscopy for CRC screening, surveillance, positive fecal-immunohistochemical tests, and diagnostic indications at one community-based center from September 2022 to March 2023. Patients were randomly assigned (1:1) to traditional colonoscopy or real-time CADe. Blinded pathologists analyzed histopathologic findings. The primary outcome was ADR (the percentage of patients with at least 1 histologically proven adenoma or carcinoma). Secondary outcomes were adenomas detected per colonoscopy (APC), sessile-serrated lesion detection rate, and non-neoplastic resection rate. RESULTS: The median age was 55.5 years (interquartile range, 50-62 years), 61% were female, 72.7% were of Hispanic ethnicity, and 9.1% had inadequate bowel preparation. The ADR for the CADe group was significantly higher than the traditional colonoscopy group (42.5% vs 34.4%; P = .005). The mean APC was significantly higher in the CADe group compared with the traditional colonoscopy group (0.89 ± 1.46 vs 0.60 ± 1.12; P < .001). The improvement in adenoma detection was driven by increased detection of <5 mm adenomas. CADe had a higher sessile-serrated lesion detection rate than traditional colonoscopy (4.7% vs 2.0%; P = .01). The improvement in ADR with CADe was significantly higher in the first half of the study (47.2% vs 33.7%; P = .002) compared with the second half (38.7% vs 34.9%; P = .33). CONCLUSIONS: In a single-center pragmatic RCT, real-time CADe modestly improved ADR and APC in average-detector community endoscopists. (ClinicalTrials.gov number, NCT05963724).

Adenoma detection rate and tolerability of two ultra-low volume bowel preparations in screening: a noninferiority randomized controlled trial.

BACKGROUND AND AIMS: The adenoma detection rate (ADR), recognized as a surrogate marker for colorectal cancer incidence and mortality reduction, is closely linked to the efficacy of bowel cleansing. However, there is a dearth of evidence examining the impact on ADR when employing two distinct very low-dose bowel cleansing products. This study sought to compare ADR in a fecal immunochemical occult blood testing (iFOBT) based organized screening program by utilizing 1L polyethylene glycol plus ascorbate (1L-PEGA) versus magnesium citrate plus picosulphate (SPMC), both administered in a split-dose regimen. METHODS: We conducted a comparative, parallel, randomized, noninferiority, and low-intervention clinical trial, the study targeted individuals from a population colorectal cancer screening program aged 50-69 with a positive iFOBT result scheduled for a work-up colonoscopy in the morning. Participants were randomized to either 1L-PEGA or SPMC for bowel cleansing. Main outcome was ADR. Secondary outcomes were bowel preparation quality, individuals' safety, tolerability and satisfaction. RESULTS: A total of 1,002 subjects were included, 501 in each group. There were no differences between groups with respect to pooled ADR (SPMC, 56.5% [52.1-60.8]; 1L-PEGA, 53.7% [49.3-58.0]; RR 0.95 [0.85-1.06]); therefore, SPMC demonstrated noninferiority in ADR compared to 1L-PEGA (difference, 2.8%; 2-sided 95% lower confidence limit (LCL), -3.4). In addition, there were no significant differences in mean lesions regardless of size and location between arms. Bowel preparation favored 1L-PEGA (96.2% vs. 89.2%; p<0.001) whereas SPMC exhibited significantly higher safety and tolerability, as evidenced by fewer non-serious treatment-emergent adverse events CONCLUSIONS: SPMC emerged as a noninferior laxative compared to 1L-PEGA concerning ADR. Despite the superior bowel preparation quality associated with 1L-PEGA, the safety, tolerability and overall satisfaction of participants were higher with SPMC. This trial was registered at ClinicalTrials.gov (EudraCT: 2019-003186-18) on March 18, 2019.

Optimal visual gaze pattern of endoscopists for improving adenoma detection during colonoscopy.

BACKGROUND AND AIMS: Visual gaze pattern (VGP) analysis quantifies endoscopists' specific eye movements. VGP during colonoscopy may be associated with polyp detection. However, the optimal VGP to maximize detection performance remains unclear. This study evaluated the optimal endoscopic VGP that enabled the highest colorectal adenoma detection. METHODS: This randomized controlled trial was conducted between July and December 2023. We developed an eye-tracking and feedback (ETF) system that instructed endoscopists to correct their gaze toward the periphery of an endoscope screen with an audible alert. Patients who underwent colonoscopy were randomly assigned to four groups: three intervention groups in which the endoscopist's gaze was instructed to a different level of the peripheral screen area using the ETF system (the periphery of 4×4, 5×5, and 6×6 divisions of the screen) and a control group in which the endoscopist did not receive instructions. The primary outcome was the number of adenomas detected per colonoscopy (APC). RESULTS: In total, 189 patients were enrolled. APC and adenoma detection rate were significantly higher in the 6×6 group than in the control group (1.82±2.41 vs. 0.59±1.17, P=0.002; 68.9% vs. 30.8%, P=0.002). The APC and the number of screen divisions were positively correlated (R=0.985, P=0.0152). The rate at which the endoscopist gazed at the periphery of the screen was positively correlated with the number of divisions (R=0.964, P=0.0363). CONCLUSIONS: Colorectal adenoma detection was improved by correcting the endoscopist's gaze to the periphery of the screen, especially by dividing the screen into 6×6 segments.

Effect of fecal immunochemical test cut-off levels on adenoma detection rate: a systematic review and meta-analysis.

BACKGROUND: Adenoma detection rate (ADR) is higher after a positive fecal immunochemical test (FIT) compared to direct screening colonoscopy. OBJECTIVE: This meta-analysis evaluated how ADR, the rates of advanced adenoma detection (AADR), colorectal cancer detection (CDR), and sessile serrated lesion detection (SSLDR) are affected by different FIT positivity thresholds. METHODS: We searched MEDLINE, EMBASE, CINAHL, and EBM Reviews databases for studies reporting ADR, AADR, CDR, and SSLDR according to different FIT cut-off values in asymptomatic average-risk individuals aged 50-74 years old. Data were stratified according to sex, age, time to colonoscopy, publication year, continent, and FIT kit type. Study quality, heterogeneity, and publication bias were assessed. RESULTS: Overall, 4280 articles were retrieved and fifty-eight studies were included (277,661 FIT-positive colonoscopies; mean cecal intubation 96.3%; mean age 60.8 years; male 52.1%). Mean ADR was 56.1% (95% CI 53.4 - 58.7%), while mean AADR, CDR, and SSLDR were 27.2% (95% CI 24.4 - 30.1%), 5.3% (95% CI 4.7 - 6.0%), and 3.0% (95% CI 1.7 - 4.6%), respectively. For each 20 µg Hb/g increase in FIT cut-off level, ADR increased by 1.54% (95% CI 0.52 - 2.56%, p < 0.01), AADR by 3.90% (95% CI 2.76 - 5.05%, p < 0.01) and CDR by 1.46% (95% CI 0.66 - 2.24%, p < 0.01). Many detection rates were greater amongst males and Europeans. CONCLUSIONS: ADRs in FIT-positive colonoscopies are influenced by the adopted FIT positivity threshold, and identified targets, importantly, proved to be higher than most current societal recommendations.

Impact of inadequate bowel cleansing in sigmoidoscopy screening.

BACKGROUND AND STUDY AIMS: Long-time follow-up of sigmoidoscopy screening trials has shown reduced incidence and mortality of colorectal cancer (CRC), but inadequate bowel cleansing may hamper efficacy. The aim of this study was to assess the impact of bowel cleansing quality in sigmoidoscopy screening. PATIENTS AND METHODS: Individuals 50 to 74 years old who had a screening sigmoidoscopy in a population-based Norwegian, randomized trial between 2012 and 2019, were included in this cross-sectional study. The bowel cleansing quality was categorised as excellent, good, partly poor, or poor. The effect of bowel cleansing quality on adenoma detection rate (ADR) and referral to colonoscopy was evaluated by fitting multivariable logistic regression models. RESULTS: 35,710 individuals were included. The bowel cleansing at sigmoidoscopy was excellent in 20,934 (58.6%) individuals, good in 6580 (18.4%), partly poor in 7097 (19.9%) and poor in 1099 (3.1%). The corresponding ADRs were 17.0%, 16.6%, 14.5%, and 13.0%. Compared to participants with excellent bowel cleansing, those with poor bowel cleansing had an odds ratio for adenoma detection of 0.66 (95% confidence interval 0.55-0.79). We found substantial differences in the assessment of bowel cleansing quality among endoscopists. CONCLUSIONS: Inadequate bowel cleansing reduces the efficacy of sigmoidoscopy screening, by lowering ADR. A validated rating scale and improved bowel preparation are needed to make sigmoidoscopy an appropriate screening method.Trial registration Clinicaltrials.gov (NCT01538550).

Prospective, randomized study comparing two different regimens of split-dose polyethylene glycol and their effect on endoscopic outcomes.

BACKGROUND: Different split regimens of polyethylene glycol are routinely used and no guidelines are available to select an optimal protocol of ingestion. This study aims to compare the efficacy and side effect profile of two different regimens of polyethylene glycol bowel preparation solution: PEG (3 + 1) vs. PEG (2 + 2). METHODS: 240 patients above the age of 18 years were included in the study between June 1st and November 31st, 2023. Patients were randomly assigned either to Group A, consisting of 115 patients receiving a 3 L of PEG the night before the colonoscopy, and 1 L the same morning of the procedure. Or to group B, where 125 patients ingested 2 L the night before the procedure, and the remaining 2 L the same morning. The cleansing efficacy was evaluated by the attending endoscopist using the Boston Bowel Preparation Scale, through a score assigned for each segment of the colon (0-3). Side effects, tolerability, and willingness to retake the same preparation were listed by an independent investigator using a questionnaire administered before the procedure. RESULTS: A higher percentage of patients had gastric fullness with the 3 + 1 vs. 2 + 2 preparation (58.3% vs. 31.2%; p <.001). A higher Boston bowel preparation score was seen in patients who took the 2 + 2 vs. 3 + 1 preparation (7.87 vs. 7.23). Using the 2 + 2 preparation was significantly associated with higher Boston bowel preparation scores vs. the 3 + 1 preparation (OR = 1.37, p =.001, 95% CI 1.14, 1.64). After adjustment over other variables (age, gender, comorbidities, previous abdominal surgeries, presence of adenoma, and time between last dose and colonoscopy), results remained the same (aOR = 1.34, p =.003, 95% CI 1.10, 1.62). CONCLUSION: While both (2 + 2) and (3 + 1) regimens of polyethylene glycol are a good choice for a successful colonoscopy, we recommend the use of (2 + 2) regimen for its superior efficacy in bowel cleansing.

Linked color imaging improves colorectal lesion detection especially for low performance endoscopists: An international trial in Asia.

BACKGROUND AND AIM: Linked color imaging (LCI) is an image-enhanced endoscopy technique that accentuates the color difference between red and white, potentially improving the adenoma detection rate (ADR). However, it remains unclear whether LCI performance in detecting colorectal lesions differs based on endoscopists' experience levels. We aimed to evaluate the differences in LCI efficacy based on the experience levels of endoscopists by conducting an exploratory analysis. METHODS: In this post hoc analysis of an international randomized controlled trial comparing the detection of adenoma and other lesions using colonoscopy with LCI and high-definition white light imaging (WLI), we included patients from 11 institutions across four countries/regions: Japan, Thailand, Taiwan, and Singapore. We retrospectively reviewed differences in the lesion detection of LCI according to endoscopists' colonoscopy history or ADR. RESULTS: We included 1692 and 1138 patients who underwent colonoscopies performed by 54 experts (experience of ≥ 5000 colonoscopies) and by 43 non-experts (experience of < 5000 colonoscopies), respectively. Both expert and non-expert groups showed a significant improvement in ADR with LCI compared to WLI (expert, 61.7% vs 46.4%; P < 0.001; non-expert, 56.6% vs 46.4%; P < 0.001). LCI had no effect on sessile serrated lesion detection rate in non-experts (3.1% vs 2.5%; P = 0.518). LCI significantly improved detection rates in endoscopists with relatively low detection performance, defined as an ADR < 50%. CONCLUSIONS: This exploratory study analyzed data from a previous trial and revealed that LCI is useful for both experts and non-experts and is even more beneficial for endoscopists with relatively low detection performance using WLI.

Comparison of the characteristics of the CF-H290I and PCF-Q260JI colonoscopes in non-sedated patients with a history of abdominal or pelvic surgery: a randomized controlled study.

BACKGROUND AND AIM: The purpose of this randomized controlled study was to compare the characteristics of the CF-H290I (high-definition) colonoscope with those of the PCF-Q260JI (high-resolution) colonoscope in non-sedated patients with a history of abdominal or pelvic surgery in an effort to help endoscopists to select more effectively and objectively between the various colonoscopes. METHODS: A total of 397 patients who underwent colonoscopy at the Affiliated Wuxi People's Hospital of Nanjing Medical University, between August 2022 and October 2022 were randomized to a CF-H290I group (n = 198) or a PCF-Q260JI group (n = 199) using a computer-generated allocation method. We compared the adenoma detection rate (ADR), patient satisfaction with the examination, discomfort associated with colonoscopy including abdominal distension and pain, cecal intubation time, and patient willingness to undergo colonoscopy in the future between the CF-H290I and PCF-Q260JI groups. RESULTS: There was no statistically significant difference in the overall ADR between the CF-H290I and PCF-Q260JI groups (81 [40.9%] vs 63 [31.7%], Z = 3.674, P = 0.055). However, the ADRs in the transverse colon and left colon were significantly higher in the CF-H290I group (22 [11.1%] vs 6 [3.0%], Z = 9.588, P = 0.002 and 57 [28.8%] vs 37 [18.6%], Z = 5.212, P = 0.017, respectively). More sessile serrated lesions were detected in the CF-H290I group (52 [26.3] vs 30 [15.1%], Z = 7.579, P = 0.006). Patient satisfaction with colonoscopy was better in the PCF-Q260JI group (8.91 ± 1.09 vs 8.51 ± 1.44, t = -3.158, P < 0.01) with less likelihood of discomfort (23 [11.6%] vs 41 [20.7%], Z = 6.144, P = 0.013), The number of patients willing to undergo colonoscopy in the future was significantly greater in the PCF-Q260JI group (168 [84.4%] vs 149 [75.3%], Z = 5.186, P = 0.023). The cecal intubation time was significantly shorter in the CF-H290I group (256.09 ± 155.70 s vs 315.64 ± 171.64 s, P = 0.004). There were no complications such as perforation or bleeding in either group. CONCLUSION: The CF-H290I and PCF-Q260JI colonoscopes each have advantages when used in patients with a history of abdominal or pelvic surgery. The CF-H290I has higher ADRs in the transverse and left colon whereas the PCF-Q260JI is less painful and better accepted by patients. This study was approved by the Clinical Research Ethics Committee of Wuxi People's Hospital and was registered in the Chinese Clinical Trial Registry (ChiCTR2200063092).