למידע נוסף חייגו 04-9931825

Efficacy of Real-Time Computer-Aided Detection of Colorectal Neoplasia in a Randomized Trial

Abstract:
Background & Aims: One fourth of colorectal neoplasias are missed during screening colonoscopies—these can develop into colorectal cancer (CRC). Deep learning systems allow for real-time computer-aided detection (CADe) of polyps with high-accuracy. We performed a multicenter, randomized trial to assess the safety and efficacy of a CADe system in detection of colorectal neoplasias during real-time colonoscopy. 

Methods: We analyzed data from 685 subjects (61.32±10.2 years old; 337 women) undergoing screening colonoscopies for CRC, post-polypectomy surveillance, or work up due to positive results from a fecal immunochemical test or signs or symptoms of CRC, at three centers in Italy from September through November 2019. Patients were randomly assigned (1:1) to groups who underwent high-definition colonoscopies with the CADe system or without (controls). The CADe system included an artificial intelligence-based medical device (GI Genius, Medtronic) trained to process colonoscopy images and superimpose them, in real time, on the endoscopy display a green box over suspected lesions. A minimum withdrawal time of 6 min was required. Lesions were collected and histopathology findings were used as the reference standard. The primary outcome was adenoma detection rate (ADR, the percentage of patients with at least 1 histologically proven adenoma or carcinoma). Secondary outcomes were adenomas detected per colonoscopy, nonneoplastic resection rate, and withdrawal time.

Results: The ADR was significantly higher in the CADe group (54.8%) than in the control group (40.4%) (relative risk [RR], 1.30; 95% CI, 1.14–1.45). Adenomas detected per colonoscopy were significantly higher in the CADe group (mean, 1.07±1.54) than in the control group (mean 0.71±1.20) (incidence rate ratio, 1.46; 95% CI, 1.15–1.86). Adenomas 5 mm or smaller were detected in a significantly higher proportion of subjects in the CADe group (33.7%) than in the control group (26.5%; RR, 1.26; 95% CI, 1.01–1.52), as were adenomas of 6–9 mm (detected in 10.6% of subjects in the CADe group vs 5.8% in the control group; RR, 1.78; 95% CI, 1.09–2.86), regardless of morphology or location. There was no significant difference between groups in withdrawal time (417±101 sec for the CADe group vs 435±149 for controls; P=.1) or proportion of subjects with resection of non-neoplastic lesions (26.0% in the CADe group vs 28.7% of controls; RR, 1.00; 95% CI, 0.90–1.12). 

Conclusions: In a multicenter, randomized trial, we found that including CADe in real-time colonoscopy significantly increases ADR and adenomas detected per colonoscopy without increasing withdrawal time. ClinicalTrials.gov no: 04079478

KEY WORDS: Artificial Intelligence, Adenoma per colonoscopy, comparison, early detection

BACKGROUND
One fourth of colorectal neoplasia is missed at screening colonoscopy [1], representing the main
cause of interval Colorectal Cancer (CRC) [2,3], and resulting in an unacceptable variability in the key
quality indicator, namely Adenoma detection rate (ADR), among endoscopists [4,5].
Failure in polyp recognition is a major determinant for this miss rate of colorectal neoplasia [6,7].
Each colonoscopy is made of approximately 50,000 frames, corresponding to approximately 25-30 frames
per second, and one polyp may be recognizable only in a few frames, explaining how failure in polyp
recognition is likely to occur, irrespectively of the endoscopy setting.
The theoretical and technological advances in Deep Learning led to the development of Computer
Aided Polyp Detection (CADe) systems. These systems showed a high-accuracy in polyp recognition when
retrospectively applied to endoscopy videos or images both in terms of true- and false-positive results [8–
11].
The impact of CADe on neoplasia detection may be considered as a good proxy for the efficacy of
these systems in reducing the miss rate, as gradients in ADR and APC are inversely related with the miss rate
after normalizing for disease-prevalence [1]. However, polyp detection does not only depend on polyp
recognition – the main factor currently addressed by CADe – as it is also affected by the degree of exposure
of the mucosa that in turn is related with the speed of withdrawal time, endoscopist skill, level of cleansing
and other factors [4]. Thus, the actual effect of CADe on detection of colorectal neoplasia is still unclear. The
only available clinical study adopted an experimental setting with two monitors (one with and one without
CADe) due to the unfeasibility of a simultaneous CADe diagnosis [12]. A new CADe system (GI-Genius,
Medtronic) avoids the need of a second display to show the AI detection box on the endoscopy image, and as
such it is fully integrated in the endoscopy workflow, enabling real-time video processing at the same frame
rate as the standard procedure, without requiring any artificial modifications of the usual colonoscopy
technique.
In addition to its efficacy, it is relevant to qualify CADe safety indicators, to better understand how it
is going to impact CRC prevention (e.g. possibile unnecessary resections, withdrawal time, etc.).
Aim of the AID (Artificial Intelligence for Colorectal Adenoma Detection) study was to assess the
safety and efficacy of a CADe system for the detection of colorectal neoplasia.

Methods 

This parallel, randomised, multicentre trial was performed in three Italian endoscopy centres 

participating in the organised population CRC screening programme (IRB: ICH2363/2019). The study was 

reported according to the CONSORT guidelines for RCTs and was registered on the ClinicalTrial.gov (NCT: 

04079478). This was a no-profit study, and no funding was received or solicited, except the loan of the 

equipment by Medtronic. All authors had access to the study data and reviewed and approved the final 

manuscript. 

Study population 

The target population included 40- to 80-years-old subjects undergoing colonoscopy for primary 

CRC screening or post-polypectomy surveillance, as well as for work-up following FIT positivity (cut

off=20 µg Hb/g faeces) or for symptoms/signs. Patients were excluded in case of personal history of CRC, or 

IBD, previous colonic resection, antithrombotic therapy precluding polyp resection, and lack of informed 

written consent. 

Artificial Intelligence (CADe) 

A Convolutional Neural Network (GI-Genius, Medtronic) was trained and validated (99.7% per

lesion sensitivity, 0.9% of false-positive frames [10]) using a series of videos of 2,684 histologically 

confirmed polyps from 840 patients enrolled in a high-quality randomized trial [13]. This CADe receives as 

input the digital image from the endoscopy processor and outputs the coordinates of a bounding box only 

when an instance of the target polyp is recognized in the image. The output appears on the same endoscopy 

screen as the system latency in outputting the video processor images with the detections is not perceivable 

by the user (1.52 ± 0.08 µs), thus allowing real-time assessment. (Figure 1). 

Randomization 

Before colonoscopy initiation, eligible subjects were randomised in a 1:1 ratio by the endoscopists to 

receive colonoscopy with or without CADe in both insertion and withdrawal phases of the procedure. 

Randomization was based on a a list of random numbers generated for each centre by the coordinating 

centre. Randomization was stratified by gender, age, and personal history of adenomas. The operator was not 

blinded to the study arm assigned to the patient. 

Colonoscopy procedures 
Colonoscopies were performed by 6 experienced endoscopists (2 for each centre; >2000 screening 

colonoscopies) in three centres participating in the organized screening program. All procedures were 

performed with a high-definition ELUXEO 700 series (EC-760R, EC-760ZP, FUJIFILM Co., Tokyo) or 

EXERA III (Olympus CV-190; Olympus Co., Tokyo). For the purpose of the study, use of magnification, 

chromoendoscopy or light-modification technologies was restricted only for polyp characterization at

endoscopist’s discretion. Bowel preparation (Appendix, Table A9) was evaluated and graded by the 

endoscopist performing the exam, using the Boston Bowel Preparation (BBPS) scale [14]. Subjects with 0 or 

1 in any one of the three segments were excluded from the primary analysis. The endoscopist and facility 

staff were allowed to adopt their standard procedures for subject management and monitoring, including use 

of conscious sedation. Caecal intubation was assessed by the endoscopist by the identification of the 

ileocecal valve and the appendix orifice via photo documentation. 

Intubation time and inspection time during withdrawal were measured using a stopwatch, pausing during 

therapeutic interventions and washing. Endoscopists were required to comply with a minimum of 6 minutes 

of inspection (i.e., clean withdrawal time) [15-16]. All polyps were classified according to their location, 

size, and morphology according to Paris classification [17]. Location was considered proximal if proximal to 

the splenic flexure. All polyps were removed (biopsy for non-resectable lesions), irrespective of size, color 

or subjective interpretation, with the exception of diminutive hyperplastic-appearing polyps located in the 

rectum and—according to the judgment of the endoscopists—not clinically significant. 

 

Histopathology 

All resected or biopsy specimens were fixed in 10% buffered formalin solution in separate jars. They 

were processed and stained for histopathology using standard methods and evaluated by expert pathologists 

participating in the organized screening program (one in each centre), who were blinded to the assigned 

examination mode. All lesions were classified according to Vienna classification [18]. An advanced 

adenoma was defined as an adenoma ≥10 mm and/or with villous component >20%, and/or high-grade 

dysplasia. 

 

Outcome measures 

The primary outcome was the adenoma detection rate (ADR) according to intervention arm. ADR 

was defined as the proportion of patients with at least one histologically proven adenoma or carcinoma [13]. 

Sessile Serrated Lesions (SSLs) were not computed in ADR calculation (ED-1; R2-3/4); Secondary 

outcomes were proximal ADR, total number of polyps detected, SSL detection rate, mean number of 

adenomas per colonoscopy (APC), cecal intubation rate, withdrawal time. The proximal ADR was defined as 

the prevalence of patients with at least one adenoma detected proximal to the splenic flexure (including 

cecum, ascending, and transverse colon). APC was defined as the total number of adenomas divided by the 

number of colonoscopies performed. APPC was defined as the total number of adenomas divided by the total 

of colonoscopies where at least one adenoma was discovered. We also defined non-neoplastic resection rate 

as the proportion of patients with no adenoma or SSL within any excised lesions who had undergone at least 

one excision with histopathological examination [13]. 

Statistical considerations 

Sample Size

The sample size was calculated based on the evaluation of primary outcome that is the per-patient 

adenoma detection rate (ADR). A sample size of 322 patients per arm was required, based on the expected 

ADR of 35% for both arms, a non-inferiority margin of 10%, power of 90% and an alpha level of 2.5% (one

sided). Non-inferiority was met for the primary endpoint if the lower 2-sided 95% confidence interval (CI) 

excluded a 10% or greater difference in favor of the control group. The 10% non-inferiority margin reflects a 

typical maximum clinically acceptable difference for comparative studies of this type. If non-inferiority was 

demonstrated for the primary endpoint, the endpoint was assessed for superiority (1-sided p value <.025) 

using the Fisher exact test. 

Statistical analysis 

The primary outcome analysis was the comparison of ADR between the two study arms. Intention

to-treat (and per protocol) analysis was conducted. Differences were expressed as relative risk (RR) with 

95% CIs. Categorical variables were described by frequency counts and percentages. Quantitative variables 

were described by mean and standard deviations. Chi-square and t-tests were used to compare categorical 

and continuous variables between the two groups, respectively. Multivariate estimations of prevalence ratios 

were obtained using log-binomial regression; adjustments were made for age, gender, colonoscopy 

indication. We also estimated the prevalence of adenomas by colonic location (distal, including the 

descending-sigmoid colon, and rectum).vs proximal colon (including, cecum, ascending, and transverse 

colon), and by morphology (Paris Classification: polypoid vs. non-polypoid lesions) in the two arms. The 

overall APC was calculated in addition to APC stratified by age, gender and colonoscopy indication. Using 

Poisson regression, we calculated incident rate ratios (IRR) to assess the relationship between study arm, 

age, gender, and colonoscopy indication. Lastly, a per-polyp analysis to assess differences in adenoma 

location, size, and morphology was also performed using mixed effects logistic regressions to control for 

multiple lesions per patient. Data were reported as odds ratios. Mixed effects models were fit with a random 

intercept and treatment as a fixed effect. We did not control for clustering within endoscopy center. A 

p < 0.05 was considered statistically significant. All statistical analyses were performed using R software 

version 3.5.1 (2018-07-02).

Results 

Study population 

A total of 700 subjects were considered eligible for the study between September and November 

2019. After the exclusion of 15 patients (Figure 2), the study cohort was represented by 685 (males: 49.2%, 

mean age 61.32+10.2 years) randomized patients. Of these, 341 were allocated in the CADe arm, and 344 in 

the control; no difference in clinical indication between the two arms was found (Table 1), and it was overall 

primary CRC screening or post-polypectomy surveillance in 46.3% (317/685), work-up of FIT+ in 30.2% 

(207/685), and GI-symptoms in 23.5% (161/685). No difference between CADe and control was observed in 

term of adequate (BBPS >2 in all colonic segments) cleansing (339/341, 99.4% vs. 342/344, 99.4%; p= 1.0) 

and caecal intubation rate (326/341 subjects, 95.6% vs. 339/344, 98.5%; p=0.7). 

 

Per-patient analysis (Figure 3) 

In the CADe group, 187/341 patients were diagnosed with at least one adenoma or CRC at 

colonoscopy as compared with 139/344 patients in the control group, corresponding to an ADR of 54.8% 

and 40.4%, respectively. After adjusting for age, gender and indication, ADR was significantly higher in the 

CADe as compared with control group (RR, 1.30; 95% CI: 1.14-1.45; Table 2; Appendix Table A1). The per 

protocol analysis produced similar results (Appendix Table A2). 

 

Regarding morphology (Table 2), the rate of patients with nonpolypoid lesions was higher in the 

CADe than in control group (90/338 [26.6%] vs. 63/343 [18.4%]; RR, 1.42 [1.09, 1.79]), as well as that with 

polypoid lesions (37.3% vs. 26.5%; RR, 1.36 [1.12, 1.62]). Regarding polyp size (Table 2), the proportion of 

patients with <10 mm adenomas was higher in the CADe group (151/341 [44.3%]) than in the control group 

(111/344, 32.3%; RR, 1.33 [1.13, 1.53]), whilst no difference for those with >10 mm as largest lesion was 

observed. As shown in Table 2, the difference between the two arms was significant for both <5 mm (RR, 

1.26; 95% CI: 1.01-1.52) and 6-9 mm adenomas (RR, 1.78 [1.09-2.86]). Regarding location (Table 2), the 

proportion of patients with proximal adenomas was higher in the CADe group (123/338 [36.4%]) than in the 

control group (97/341, 28.4%; RR, 1.28 [1.03, 1.59]), as well as that with distal adenomas (109/338 [37.0%] 

vs. 72/341 [23.6%], 37%; RR, 1.53 [1.18, 1.98]). Regarding multiplicity, 131 (19.1%) patients had >2 

adenomas: percentages of patients with multiple adenoma in CADe and control group were 23.2% (79) and 

15.1% (52), respectively (RR, 1.50; 95% CI:1.19-1.95). 

 

Regarding histology, 45 patients were diagnosed with advanced neoplasia in the CADe group, 

compared with 36 control group patients, corresponding to a detection rate of advanced neoplasia of 13.2% 

and 10.5%, respectively (adjusted RR: 1.22; 95% CI: 0.80-1.93, Table 2; Appendix Table A1). No 

difference in the proportion of patients with at least one SSL was found between the two groups (CADe, 

7.0% vs control, 5.2%; p=0.326). 

Individual detection rates of at per centre and endoscopist levels are provided in the Appendix (Table 

A5-A8), as well as ADR according to indications. 

 

Non-neoplastic resection rate 

Overall, 460/685 (67.1%) patients had polyp resections. Of these, 120/460 (27.1%) did not have 

histologically proven adenomas, SSLs, or CRCs. The non-neoplastic resection rate were 68/262 (26.0%) and 

57/198 (28.8%) in CADe and control group, respectively (RR:1.00; 95% CI:0.90-1.12; P=0.940). 

 

Per polyp analysis 

In the 262 and 198 patients with polyp resection in the CADe and control groups, 353 and 243 

adenomatous polyps were detected, respectively. Characteristics of detected polyps and cancers according to 

intervention arm are summarized in Appendix Tables A3 and A4. 

The APC overall was 0.87±1.39 (Table 3), and it was significantly higher in the CADe than in the 

control group (1.07±1.54 versus 0.71±1.20), IRR, 1.46; 95% CI:1.15-1.86). The association between the 

APC and study arm remained significant after adjusting for gender, indication, and withdrawal time in a 

random effect model (OR, 1.80; 95% CI:1.14-2.81) (Appendix Table A4). 

Differences in APC between CADe and control group were also analysed according to polyp 

characteristics, as detailed in (Table 3). A statistically significant increase in APC between CADe and 

control group was found for both polypoid and nonpolypoid lesions, as well as for both proximal and distal 

locations. Regarding polyp size the difference was significant only for <10 mm polyps. 

Discussion 

The addition of real-time CADe to colonoscopy resulted in a 30% and 46% relative increase in ADR 

and APC, demonstrating its efficacy in improving the detection of colorectal neoplasia at screening and 

diagnostic colonoscopy. Safety of CADe was demonstrated by the lack of increase of both useless resections 

and withdrawal time, as well as by the exclusion of any underskilling in the study period. CADe efficacy 

appeared to be independent of morphology and location of neoplasia, and it was mainly explained by the 

additional detection of <5 mm and 6-9 mm polyps. 

 

CADe was already shown to be highly accurate for polyp recognition in retrospective assessment of 

videos with already diagnosed polyps [8–10]. However, there was uncertainty on its impact on polyp 

detection that also depends on the degree of mucosa exposure. The 14% absolute increase in ADR obtained 

by CADe in our study indicates that failure in polyp recognition is a clinically relevant cause of miss rate. Of 

note, the efficacy of CADe in reversing such miss rate also indicates that the same operator that missed the 

lesion in the first place was able to correctly diagnose it when the lesion was presented by the CADe. This 

underlines that the main cognitive challenge in polyp recognition is the discrimination between the candidate 

lesion and the surrounding healthy mucosa, while its correct characterization as neoplastic tissue – that 

occurs after CADe detection – is apparently a much easier task. This is well in line with previous evidence 

that the use of dye-spray or electronic chromoendoscopy was able to increase the ADR of the operator by 

emphasizing the contrast between the neoplastic and healthy tissue [13,19]. The additional advantage of 

CADe is that it completely automatizes – by presenting a well delimited box around the putative lesion 

(Figure 1) – the detection phase, while chromoendoscopy still requires the endoscopist to identify the lesion 

in the first place. Future studies should address whether the addition of CADe over chromoendoscopy further 

improves neoplasia detection over CADe alone. 

 

Our study setting allowed us to assess the safety of CADe colonoscopy for experienced endoscopists. 

Differently from previous studies based on experimental setting [12], we fully integrated CADe in the 

endoscopy system, completely mimicking the usual routine of the operators by over-imposing the CADe box 

over the same endoscopic screen. Our study excludes any under-skilling effect – i.e. an ADR reduction – on 

the operators, marginalizing any possibility for the CADe to distract or reduce the level of alertness of the 

operator. Secondly, we excluded any clinically relevant effect of non-neoplastic resections due to CADe. 

First, the actual number of patients with useless resection of non-neoplastic polyps did not increase. 

Secondly, there was not increase in the withdrawal time. Both of these outcomes indicate that the 

endoscopist is fast and accurate in lesion characterization, discarding non-neoplastic lesions detected by 

CADe with the same competence as when detected without it. Despite we did not assess the actual number of 

false positive activations by the system, as this would have altered the routine setting of our study, we 

already showed such number to be less than 1% of the whole colonoscopy video [10]. 

 

The contribution of small lesions to the gradient between the two study arms is in line with pooling 

of tandem studies showing such lesions to be associated with miss rate at colonoscopy [20]. When 

considering the additional detection as a proxy for a reduction of miss rate, CADe was able to increase the 

ADR by targeting the miss rate of the most subtle lesions in the colonoscopy field. The correspondence 

between the increase in ADR and APC underlines the efficacy of CADe not only in classifying qualitatively 

one patient as an adenoma-bearing or negative one, but also in correctly diagnosing all the burden of 

neoplasia that occur in each single patient. Such synergic effect should anticipate a more profound result in 

terms of post-colonoscopy CRC prevention. Of note, the proportion of patients with multiplicity was higher 

in the CADe as compared with control arm. 

 

The independence of the CADe effect from location and morphology is also in line with previous 

tandem studies that excluded a role for proximal location as well as for sessile versus flat morphology in the 

miss rate of neoplasia at colonoscopy [20]. Contrarily, the association between increased yield and <10 mm 

size was not unexpected as miss rate for these lesions appeared to be substantially superior to those for >10 

mm lesions in the pooling of tandem studies [20]. Due to the high prevalence and subtle appearance, 

diminutive and small lesions may be considered as a proxy for the technical competence of the endoscopist. 

Such competence in turn has been strictly associated with the degree of post-colonoscopy CRC risk. 

 

There are limitations to our analysis. First, we could not exclude a psychological bias as the operator 

was aware of the randomized intervention. However, the ADR in the control arm was actually superior (41% 

vs. 35%, Appendix Table A5) to what it was previously recorded in the clinical setting of one of the three 

centres and used to estimate the sample size. The ADR in the control arm was approximately 2-fold superior 

to the previous CADe study with an experimental setting [12], being more representative of the western-like 

endoscopy setting. In addition, the equivalence in withdrawal time exclude a somewhat reduced degree of 

mucosal exposure in the control arm. When selecting only the FIT+ patients, the ADR in the control arm was 

also in line with previous studies from our group (Appendix Table 5). Finally, the increase in ADR was 

consistent in all the three centres involved (Appendix Table A5), marginalizing the possibility of operator

related bias. Third, we did not include low-detectors, inexperienced or non-gastroenterologist endoscopists in 

our study. Thus, there is uncertainty on whether CADe would be equally beneficial in these categories for the 

following reasons. First, low-detectors have been shown to be suboptimal in the technical exposure of 

colorectal mucosa. Thus, the additional contribution of an improved polyp recognition with CADe is 

uncertain. Secondly, we cannot exclude that less experienced endoscopists would remove an excess of non

neoplastic lesions triggered by false positive results, differently from what reported in our analysis. 

Alternatively, endoscopists with less experience could require more time to assess the false positives by 

CADe, affecting the efficiency of the colonoscopy procedure, i.e. prolonging the withdrawal time. 

 

In conclusion, we showed the safety and efficacy of integrating CADe in real-time colonoscopy. The 

substantial improvement of ADR and APC without increasing the removal of non-neoplastic lesions is likely 

to improve the quality of colonoscopy without affecting its efficiency.

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Figure Captions 

Figure 1 – CADe is able to identify and localize the adenomatous lesion in real-time colonoscopy. The output appears on the same screen of the endoscopy system without affecting the routinely technique of the operator. 

 

Figure 2 – Study flow-chart including clinical outcomes. *Relative Risk 1.34 (1.19-1.48) § Incidence Risk Ratio 1.53 (1.13-2.07) 

Figure 3 – (Per-patient) Adenoma detection rate as well as (Per-patient) ADR by adenomas features. A) Adenoma Size Category, large (≥10mm) vs small (<10 mm); B) Adenoma Morphology, polypoid: [pedunculated (0-1p), sessile (0-1s) or mixed (0-1sp)] vs. non-polypoid lesions: [superficial slightly elevated (IIa), flat (IIb), superficial depressed (IIc), and excavated (III) types]. C) Sessile serrated Lesions, (SSL). D) Colon location, proximal colon (Cecum, ascending, and transverse) vs. distal colon (Descending, sigmoid, and rectum). The asterisk indicates statistically significant difference between the two arms. 

Table 1. Patients’ characteristics by according to intervention arm. 

Variable 

 

CADe (341 patients) 

Control (344 patients) P-Value 

Mean Age (SD), years 61.5 (9.7) 61.1 (10.6) 0.442 

Gender, n (%) 0.541 

Female 169 (49.6) 179 (52.0) 

Male 172 (50.4) 165 (49.6) 

Indication for colonoscopy, n (%) 0.818 

FIT+ 102 (29.9) 105 (30.5) 

Primary CRC Screening 77 (22.6) 76 (22.1) 

Surveillance 86 (25.2) 78 (22.7) 

GI Symptoms 76 (22.3) 85 (24.7) 

Mean BBPS score (SD) 

Right Colon 2.4 (0.50) 2.4 (0.52) 0.748 

Transverse 2.5 (0.50) 2.5 (0.52) 0.943 

Left Colon 2.5 (0.51) 2.5 (0.50) 0.645 Adequate preparation (BBPS >2 in all segments) 339 (99.4) 342 (99.4) 0.999 

Mean Insertion Time (IQR), minutes 9.0 (5-11) 8.1 (2-10) 0.056 

Mean Inspection Time (IQR), sec 7.3 (6-8) 7.0 (6-8) 0.100 # of polyps of any histology per patient (range) 1.89 (0-13) 1.24 (0-9) <0.001 SD, Standard deviation; FIT, fecal immunochemical test; BBPS, Boston Bowel Preparation Scale, IQR, interquartile range. * The information was missing in 7 and 13 cases in CADe e Control arm, respectively. 

Table 2. Detection rate according to intervention arm, as well as per patient distribution of adenomatous polyps according to morphology, size, and location. 

 

Per patient analysis^ 

CADe (N=341) 

Control (N=344) 

Total Number (N=685) 

RR [95% CI] P-value 

 

Histology 

All adenomas and CRCs 187 (54.8) 139 (40.4) 326 (47.6) 

1.30 (1.14-1.45)§ <0.001 

 

Non-advanced adenomas 142 (41.6) 103 (29.9) 245 (35.8) 

1.35 (1.13-1.57) 0.001 

 

Advanced adenomas† 35 (10.3) 33 (7.3) 68 (9.9) 

1.07 (0.68-1.66) 0.769 

 

adenocarcinoma (CRC) 10 (2.9) 3 (0.9) 13 (1.9) 

3.36 (0.93-12.11) 0.067 

 

Sessile serrated Lesion 24 (7.0) ç 18 (5.2) 42 (6.1) ç 

1.34 (0.75-2.37) 0.326 

 

Non-neoplastic polyp* 68 (19.9) 57 (16.6) 125 (18.2) 

1.20 (0.88-1.65) 0.254 

 

Size category‡ <5 mm 115 (33.7) 91 (26.5) 206 (30.1) 

1.26 (1.01-1.52) 0.038 

 

6-9 mm 36 (10.6) 20 (5.8) 56 (8.2) 

1.78 (1.09-2.86) 0.025 

 

≥10 mm 36 (10.6) 28 (9.1) 64 (9.3) 

1.29 (0.81-2.02) 0.278 

Morphology†‡ Polypoid* 126 (37.3) 91 (26.5) 

217 (31.9) 1.36 (1.12-1.62) 0.003 

Non-polypoid**†† 90 (26.6) 63 (18.4) 

153 (22.5) 1.42 (1.09-1.79) 0.010 

 

Location‡ Proximal Colon°‡‡ 123 (36.1) 97 (28.2) 

 

220 (32.1) 

1.28 (1.03-1.59) 0.028 

 

Distal Colon°° 109 (32.0) 72 (20.9) 

 

181 (26.4) 

1.53 (1.18-1.98) 0.001 

^ It refers to proportion of patients with at least one adenoma or CRC, unless otherwise specified. §After adjustement for age, gender, and colonoscopy indication; crude RR for adenoma detection rate: 1.36 (1.16-1.59); crude RR for advanced neoplasia detection rate: 1.30 (0.86-1.99). *Normal, hyperplastic, inflammatory and others. ‡According to the size of the largest neoplastic lesion. †‡There were 4 cases with missing data: 3 in the CADe and 1 in the control group. *[elevated more than 2.5 mm above the mucosal layer: pedunculated (0-1p), sessile (0-1s) or mixed (0-1sp)]. **non-polypoid lesions: superficial slightly elevated (IIa), flat (IIb), superficial depressed (IIc), and excavated (III) types. †Advanced adenoma was defined as an adenoma of 10 mm or more, or as an adenoma (irrespective of size) with 

at least 25% villous histology or with high-grade dysplasia. ç2 SSL with cytological dysplasia, corresponding to a cumulative SSL with dysplasia/all SSL ratio of 4.8% ††Including 29 (8.6%) CADe and 14 (4.1%) control group cases who had synchronous polypoid adenomas. ‡‡Including 45 (13.2%) CAD-e and 30 (8.7%) control cases who had synchronous adenomas in the distal colon. °Cecum, ascending, and transverse. °°Descending, sigmoid, and rectum

Table 3 – Per polyp analysis: mean number of adenomas per colonoscopy (APC) and Poisson regression analysis by polyp characteristics among study participants (n = 685). IRR, incidence risk ratio as adjusted for patient age, gender, and indication. 

Per polyp analysis 

CAD-e 

 

Control 

 

IRR [95% CI] 

APC (SD) APC (SD) Morphology†‡ 

Polypoid* 0.61 (1.20) 0.42 (0.92) 1.44 (1.05-1.96) Non-polypoid**†† 0.42 (0.94) 0.28 (0.83) 1.47 (1.00-2.15) 

Size‡ <10 mm 0.92 (1.40) 0.62 (1.08) 1.50 (1.17-1.91) ≥10 mm 0.11 (0.35) 0.09 (0.31) 1.07 (0.66-1.74) 

Location‡ Proximal Colon°‡‡ 0.60 (1.10) 0.45 (0.92) 1.35 (1.00-1.81) Distal Colon°° 0.43 (0.79) 0.26 (0.80 1.60 (1.14-2.07) 

 

‡There were missing data in 3 CADe cases and 3 control case.*[elevated more than 2.5 mm above the mucosal layer: pedunculated (0-1p), sessile (0-1s) or mixed (0-1sp)]. **non-polypoid lesions: superficial slightly elevated (IIa), flat (IIb), superficial depressed (IIc), and excavated (III) types. ††Including 29 (8.5%) CADe and 14 (4.1%) control group cases who had synchronous polypoid adenomas. ‡‡Including 45 (13.2%) CAD-e and 30 (8.7%) control cases who had synchronous adenomas in the distal colon.°Cecum, ascending, and transverse. °°Descending, sigmoid, and rectum

 

What you need to know: Background and Context: Deep learning systems allow for real-time computer-aided detection (CADe) of polyps with high-accuracy, but these systems have not been tested in randomized trials. 

 

New Findings: In randomized trial, inclusion of CADe in colonoscopy significantly increased adenoma detection rates and adenomas detected per colonoscopy, without increasing withdrawal time. Higher proportions of adenomas smaller than 5 mm and 6–9 mm were detected with CADe, regardless of morphology or location. 

Limitations: This study was performed in an expert setting; studies are needed for inexperienced endoscopists. 

 

Impact: Including CADe in colonoscopy examinations increases detection of adenomas without affecting safety. 

 

Lay Summary: Including real-time, computer-aided detection of polyps in colonoscopy examination increases rates of adenoma detection by 30%.