scholarly journals Clinical validation of the SIMPLE classification for optical diagnosis of colorectal polyps

2021 ◽  
Vol 09 (05) ◽  
pp. E684-E692
Author(s):  
Ahmed Amine Alaoui ◽  
Kussil Oumedjbeur ◽  
Roupen Djinbachian ◽  
Étienne Marchand ◽  
Paola N. Marques ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Colorectal Polyps ◽  
Clinical Validation ◽  
Optical Diagnosis ◽  
Clinical Cohort ◽  
Simple Classification ◽  
Surveillance Interval ◽  
Colonoscopy Surveillance ◽  
Secondary Outcomes ◽  
Diagnosis Classification

Abstract Background and study aims A novel endoscopic optical diagnosis classification system (SIMPLE) has recently been developed. This study aimed to evaluate the SIMPLE classification in a clinical cohort. Patients and methods All diminutive and small colorectal polyps found in a cohort of individuals undergoing screening, diagnostic, or surveillance colonoscopies underwent optical diagnosis using image-enhanced endoscopy (IEE) and the SIMPLE classification. The primary outcome was the agreement of surveillance intervals determined by optical diagnosis compared with pathology-based results for diminutive polyps. Secondary outcomes included the negative predictive value (NPV) for rectosigmoid adenomas, the percentage of pathology exams avoided, and the percentage of immediate surveillance interval recommendations. Analysis of optical diagnosis for polyps ≤ 10 mm was also performed. Results 399 patients (median age 62.6 years; 55.6 % female) were enrolled. For patients with at least one polyp ≤ 5 mm undergoing optical diagnosis, agreement with pathology-based surveillance intervals was 93.5 % (95 % confidence interval [CI] 91.4–95.6). The NPV for rectosigmoid adenomas was 86.7 % (95 %CI 77.5–93.2). When using optical diagnosis, pathology analysis could be avoided in 61.5 % (95 %CI 56.9–66.2) of diminutive polyps, and post-colonoscopy surveillance intervals could be given immediately to 70.9 % (95 %CI 66.5–75.4) of patients. For patients with at least one ≤ 10 mm polyp, agreement with pathology-based surveillance intervals was 92.7 % (95 %CI 89.7–95.1). NPV for rectosigmoid adenomas ≤ 10 mm was 85.1 % (95 %CI CI 76.3–91.6). Conclusions IEE with the SIMPLE classification achieved the quality benchmark for the resect and discard strategy; however, the NPV for rectosigmoid polyps requires improvement.

scholarly journals A79 CLINICAL VALIDATION OF THE SIMPLE CLASSIFICATION FOR OPTICAL DIAGNOSIS OF DIMINUTIVE AND SMALL COLORECTAL POLYPS

2020 ◽  
Vol 3 (Supplement_1) ◽  
pp. 93-94
Author(s):  
A Alaoui ◽  
K Oumedjbeur ◽  
R Djinbachian ◽  
E Marchand ◽  
P Marques ◽  
...  
Keyword(s):  
Colorectal Polyps ◽  
Adenomatous Polyps ◽  
Prospective Clinical Study ◽  
Study Cohort ◽  
Clinical Validation ◽  
The Novel ◽  
Optical Diagnosis ◽  
Simple Classification ◽  
Funding Agencies ◽  
Surveillance Interval

Abstract Background Image enhanced endoscopy (IEE) allows for real-time optical diagnosis of colorectal polyps in order to replace histopathology. A novel classification system (SIMPLE classification) has recently been developed for optical diagnosis when using the novel Pentax Optivista IEE platform. Aims The aim of this study was to evaluate the SIMPLE classification for optical polyp diagnosis in a prospective clinical study. Methods Patients undergoing screening, diagnostic or surveillance colonoscopies were enrolled in the study. All colorectal polyps 1-10mm found underwent optical polyp diagnosis using the SIMPLE classification with either iScan or Optivista for image-enhanced endoscopy (IEE). Polyps were resected as per standard care and sent for histopathology analysis. Optical diagnosis and surveillance intervals were calculated based on SIMPLE criteria and compared to pathology-based results as reference. Primary outcome was the agreement of the surveillance intervals based on the SIMPLE classification with pathology-based surveillance intervals for 1-5mm colorectal polyps. Secondary outcomes included negative predictive value (NPV) for rectosigmoid adenoma, percentage of pathology avoided, percentage of post-colonoscopy immediate recommendations, and surveillance interval agreement, rectosigmoid NPV for 1-10mm polyps. Results 399 patients (mean age: 62.4, 55.6% female) with 278 diminutive and 364 small polyps were evaluated in the study cohort. For ≤5mm polyps, agreement with pathology-based surveillance intervals was 93.5% [95% CI 91.1–95.9] (shorter: 4.5% [95% CI 2.5–6.5]; longer: 1.8% [95% CI 0.5–3.0]). NPV for rectosigmoid adenomatous polyps (including SSA) was 85.5% [95% CI 77.6–93.4]. Using Optical diagnosis and the SIMPLE classification, pathology analysis could be avoided in 61.5% [95% CI 56.9–66.2] of polyps and post-colonoscopy immediate surveillance interval recommendation could be given in 70.9% [95% CI 66.5–75.4] of patients. For ≤10mm polyps, agreement with pathology-based surveillance intervals was 92.2% [95% CI 89.6–94.9] (shorter: 5.5% [95% CI 3.3–7.8]; longer: 2.3% [95% CI 0.8–3.7]). NPV for rectosigmoid adenomatous polyps (including SSA) was 83.7% [95% CI 75.9–91.5]. Conclusions The first clinical validation study using the SIMPLE classification in combination with Optivista or iScan IEE showed a high (≥90%) surveillance interval agreement compared to pathology. More than 60% of pathology could be avoided, and most patients could be given immediate surveillance intervals when using IEE in combination with the SIMPLE classification. Funding Agencies NonePentax

scholarly journals Mo1624 CLINICAL VALIDATION OF THE SIMPLE CLASSIFICATION FOR OPTICAL DIAGNOSIS OF DIMINUTIVE AND SMALL COLORECTAL POLYPS

2020 ◽  
Vol 91 (6) ◽  
pp. AB424-AB425
Author(s):  
Ahmed Amine Alaoui ◽  
Kussil Oumedjbeur ◽  
Roupen Djinbachian ◽  
Etienne Marchand ◽  
Paola Marques ◽  
...  
Keyword(s):  
Colorectal Polyps ◽  
Clinical Validation ◽  
Optical Diagnosis ◽  
Simple Classification

scholarly journals A118 POLYP SIZE CUT-OFF LEVEL TO IMPLEMENT OPTICAL POLYP DIAGNOSIS

2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 98-99
Author(s):  
M Taghiakbari ◽  
R Djinbachian ◽  
D von Renteln
Keyword(s):  
Colorectal Polyps ◽  
Optical Diagnosis ◽  
Clinical Implementation ◽  
Polyp Size ◽  
Funding Agencies ◽  
Size Groups ◽  
Surveillance Interval ◽  
High Reduction ◽  
Advanced Adenomas ◽  
Post Hoc

Abstract Background Optical polyp diagnosis can be used for real-time pathology prediction of colorectal polyps ≤10 mm. However, the risk of misdiagnosing a polyp with advanced pathology potentially increases with increasing polyp size. Aims This study aimed to evaluate different size cut-offs for using optical polyp diagnosis and the associated risk of patients undergoing inadequate follow-up or surveillance. Methods In a post-hoc analysis of two prospective studies, the performance of optical diagnosis was evaluated in three polyp size groups: 1–3 mm, 1–5 mm, and 1–10 mm. The primary outcome was the proportion of patients with advanced adenomas and delayed or inappropriate surveillance. Secondary outcomes included percentage of polyps with advanced pathology, agreement between surveillance intervals based on high-confidence optical diagnosis and pathology outcomes, reduction in histopathological examinations, and proportion of patients who could receive an immediate surveillance interval recommendation. Results We included 1525 patients with complete colonoscopies (mean age 62.9 years, 50.2% male). The percentage of patients with advanced adenomas and delayed or inappropriate surveillance was 0.7%, 1.7%, and 1.8% when using optical diagnosis for patients with polyps of 1–3, 1–5, and 1–10 mm, respectively. The percentage of polyps with advanced pathology was 0.5%, 1.4%, and 1.9%, respectively. Surveillance interval agreement between pathology and optical diagnosis was 99%, 98%, and 97.8%, respectively. Total reduction in pathology examinations was 33.9%, 53.5%, and 69.0%, respectively. Conclusions A 3-mm cut-off for clinical implementation of optical polyp diagnosis yielded high surveillance interval agreement with pathology and a high reduction in pathology examinations while minimizing the risk of inappropriate management for polyps with advanced pathology. Funding Agencies None

scholarly journals A119 THE LOCATION-BASED RESECT AND DISCARD STRATEGY FOR DIMINUTIVE COLORECTAL POLYPS: A PROSPECTIVE CLINICAL STUDY

2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 99-101
Author(s):  
M Taghiakbari ◽  
H Pohl ◽  
R Djinbachian ◽  
A N Barkun ◽  
P Marques ◽  
...  
Keyword(s):  
Task Force ◽  
A Priori ◽  
Cost Effective ◽  
Colorectal Polyps ◽  
Prospective Clinical Study ◽  
Colon Polyps ◽  
Optical Diagnosis ◽  
Cost Effective Approach ◽  
Surveillance Interval ◽  
Task Force Guideline

Abstract Background Replacing histopathology evaluation of diminutive polyps with optical polyp diagnosis is considered a cost-effective approach. However, the widespread use of optical diagnosis is limited due to concerns about making incorrect optical diagnoses and the requirements of training, credentialing and auditing of performance. Aims This prospective study aimed to evaluate a simplified resect and discard strategy that is not operator dependent. Methods The study evaluated a resect and discard strategy that uses anatomical polyp location to classify colon polyps into non-neoplastic or low-risk neoplastic. All rectosigmoid diminutive polyps were considered hyperplastic and all polyps located proximally to the sigmoid colon were considered neoplastic. Surveillance interval assignments based on these a priori assumptions were compared with those based on actual pathology results and optical diagnosis, respectively. The primary outcome was ≥90% agreement with pathology in surveillance interval assignment. Results Overall, 1117 patients undergoing complete colonoscopy were included and 482 (43.1%) had at least one diminutive polyp. Surveillance interval agreement between the location-based resect and discard strategy and pathological findings using the 2020 US Multi-Society Task Force guideline was 97.0% (95% CI = 0.96 - 0.98), surpassing the ≥90% benchmark. Optical diagnoses using NICE and Sano classifications reached 89.1% and 90.01% agreement, respectively (p <0.0001), and were inferior to the location-based strategy. The location-based resect and discard strategy allowed a 69.7% (95% CI = 0.67 - 0.72) reduction in pathology examinations compared with 55.3% (95% CI = 0.52 - 0.58) (NICE and Sano) and 41.9% (95% CI = 0.39 - 0.45) (WASP) with optical diagnosis. Conclusions The location-based resect and discard strategy achieved very high surveillance interval agreement with pathology-based surveillance interval assignment, surpassing the ≥90% quality benchmark and outperforming optical diagnosis in surveillance interval agreement and the number of pathology examinations avoided. Funding Agencies None

Evaluation of the polyp-based resect and discard strategy: a retrospective study

Endoscopy ◽  
2021 ◽  
Author(s):  
Antoine Duong ◽  
Heiko Pohl ◽  
Roupen Djinbachian ◽  
Annie Deshêtres ◽  
Alan N. Barkun ◽  
...  
Keyword(s):  
Multiple Testing ◽  
Primary Outcome ◽  
Task Force ◽  
Colorectal Polyps ◽  
Surveillance Interval ◽  
Almost All ◽  
A Prospective Study ◽  
Post Hoc ◽  
Standard Colonoscopy

Abstract Background Standard colonoscopy practice requires removal and histological characterization of almost all detected small (< 10 mm) and diminutive (≤ 5 mm) colorectal polyps. This study aimed to test a simplified polyp-based resect and discard (PBRD) strategy that assigns surveillance intervals based only on size and number of small/diminutive polyps, without the need for pathology examination. Methods A post hoc analysis was performed on patients enrolled in a prospective study. The primary outcome was surveillance interval agreement of the PBRD strategy with pathology-based management according to 2020 US Multi-Society Task Force guidelines. Chart analysis also evaluated clinician adherence to pathology-based recommendations. One-sided testing was performed with a null-hypothesis of 90 % agreement with pathology-based surveillance intervals and a two-sided 96.7 % confidence interval (CI) using correction for multiple testing. Results 452 patients were included in the study. Surveillance intervals assigned using the PBRD strategy were correct in 97.8 % (96.7 %CI 96.3–99.3 %) of patients compared with pathology-based management. The PBRD strategy reduced pathology examinations by 58.7 % while providing 87.8 % of patients with immediate surveillance interval recommendations on the day of colonoscopy, compared with 47.1 % when using pathology-based management. Chart analysis of surveillance interval assignments showed 63.3 % adherence to pathology-based guidelines. Conclusion The PBRD strategy surpassed the 90 % agreement with the pathology-based standard for determining surveillance interval, reduced the need for pathology examinations, and increased the proportion of patients receiving immediate surveillance interval recommendations. The PBRD strategy does not require expertise in optical diagnosis and may replace histological characterization of small and diminutive colorectal polyps.

scholarly journals A78 COMPARISON OF THE NICE, SANO, AND WASP CLASSIFICATIONS FOR OPTICAL DIAGNOSIS OF SMALL COLORECTAL POLYPS

2020 ◽  
Vol 3 (Supplement_1) ◽  
pp. 92-93
Author(s):  
R Djinbachian ◽  
H Pohl ◽  
E Marchand ◽  
P Marques ◽  
M Bouin ◽  
...  
Keyword(s):  
Correct Diagnosis ◽  
Colorectal Polyps ◽  
Classification Systems ◽  
Optical Diagnosis ◽  
Polyp Detection ◽  
Detection Rates ◽  
Adenoma Detection ◽  
Multiple Classification ◽  
Surveillance Interval ◽  
Adenoma Detection Rates

Abstract Background Optical diagnosis can be used as an alternative to pathology for the evaluation of colorectal polyps. There exist multiple classification systems that can be used to assist in performing optical diagnosis. Aims The aim of this study was to compare three different optical diagnosis classifications (NICE, SANO and WASP) when using Optivista and iScan image enhanced endoscopy (IEE). Methods The study included subjects between 45–80 years undergoing an elective screening, surveillance, or diagnostic colonoscopy with optical diagnosis using Optivista or iScan IEE. Three validated IEE scales (NICE, SANO and WASP classifications) were used for all optical diagnoses. Primary outcome was the agreement with pathology for surveillance intervals determined when using NICE, SANO and WASP for polyps 1-10mm. Secondary outcomes for polyps 1-10mm included accuracy of polyp diagnosis and negative predictive value (NPV) for rectosigmoid adenomas. Results A total of 399 patients were prospectively enrolled in the trial. The polyp detection and adenoma detection rates were 58.6% and 38.8% respectively. The proportion of correct surveillance interval assignment when at least one optical diagnosis was made was 92.9% when using NICE, 92.3% when using SANO, 89.5% when using WASP (p=0.656). Correct diagnosis was made for 74.2% of polyps when using NICE, 74.2% when using SANO, 65.6% when using WASP (p=0.012). The NPV for rectosigmoid adenomas was 91.2% when using NICE, 90.5% when using SANO, 87.5% when using WASP. Conclusions For optical diagnosis using Optivista and iScan IEE, all studied classifications performed equally for surveillance interval assignment. WASP had lower proportion of correct diagnoses on a polyp level and lower NPV for rectosigmoid adenomas. Funding Agencies None

The location-based resect and discard strategy for diminutive colorectal polyps: a prospective clinical study

Endoscopy ◽  
2021 ◽  
Author(s):  
Mahsa Taghiakbari ◽  
Heiko Pohl ◽  
Roupen Djinbachian ◽  
Alan Barkun ◽  
Paola Marques ◽  
...  
Keyword(s):  
Task Force ◽  
A Priori ◽  
Colonic Polyps ◽  
Colorectal Polyps ◽  
Prospective Clinical Study ◽  
Optical Diagnosis ◽  
Clinical Implementation ◽  
Surveillance Interval ◽  
Task Force Guideline ◽  
Very High

Abstract Background Clinical implementation of the resect-and-discard strategy has been difficult because optical diagnosis is highly operator dependent. This prospective study aimed to evaluate a resect-and-discard strategy that is not operator dependent. Methods The study evaluated a resect-and-discard strategy that uses the anatomical polyp location to classify colonic polyps into non-neoplastic or low risk neoplastic. All rectosigmoid diminutive polyps were considered hyperplastic and all polyps located proximally to the sigmoid colon were considered neoplastic. Surveillance interval assignments based on these a priori assumptions were compared with those based on actual pathology results and on optical diagnosis. The primary outcome was ≥ 90 % agreement with pathology in surveillance interval assignment. Results 1117 patients undergoing complete colonoscopy were included and 482 (43.1 %) had at least one diminutive polyp. Surveillance interval agreement between the location-based strategy and pathological findings using the 2020 US Multi-Society Task Force guideline was 97.0 % (95 % confidence interval [CI] 0.96–0.98), surpassing the ≥ 90 % benchmark. Optical diagnoses using the NICE and Sano classifications reached 89.1 % and 90.01 % agreement, respectively (P < 0.001), and were inferior to the location-based strategy. The location-based resect-and-discard strategy allowed a 69.7 % (95 %CI 0.67–0.72) reduction in pathology examinations compared with 55.3 % (95 %CI 0.52–0.58; NICE and Sano) and 41.9 % (95 %CI 0.39–0.45; WASP) with optical diagnosis. Conclusion The location-based resect-and-discard strategy achieved very high surveillance interval agreement with pathology-based surveillance interval assignment, surpassing the ≥ 90 % benchmark and outperforming optical diagnosis in surveillance interval agreement and the number of pathology examinations avoided.

scholarly journals Healthy eating and lifestyle in pregnancy (HELP): a cluster randomised trial to evaluate the effectiveness of a weight management intervention for pregnant women with obesity on weight at 12 months postpartum

2021 ◽  
Author(s):  
Sharon A. Simpson ◽  
Elinor Coulman ◽  
Dunla Gallagher ◽  
Karen Jewell ◽  
David Cohen ◽  
...  
Keyword(s):  
Weight Management ◽  
Healthy Eating ◽  
Primary Outcome ◽  
Intervention Group ◽  
Control Group ◽  
Risky Drinking ◽  
Management Intervention ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Weight Management Intervention

Abstract Objective To assess whether a weight management intervention for pregnant women with obesity was effective in reducing body mass index (BMI) 12 months after giving birth. Methods Pragmatic, cluster randomised controlled trial (RCT) with embedded cost-effectiveness analysis. 598 women with a BMI of ≥30 kg/m2 (between 12 and 20 weeks gestation) were recruited from 20 secondary care maternity units in England and Wales. BMI at 12 months postpartum was the primary outcome. A range of clinical and behavioural secondary outcomes were examined. Interventions Women attending maternity units randomised to intervention were invited to a weekly weight management group, which combined expertise from a commercial weight loss programme with clinical advice from midwives. Both intervention and control participants received usual care and leaflets on diet and physical activity in pregnancy. Results Mean (SD) BMI at 12 months postpartum was 36.0 kg/m2 (5.2) in the control group, and 37.5 kg/m2 (6.7) in the intervention group. After adjustment for baseline BMI, the intervention effect was −0.02 (95% CI −0.04 to 0.01). The intervention group had an improved healthy eating score (3.08, 95% CI 0.16 to 6.00, p < 0.04), improved fibre score (3.22, 1.07 to 5.37, p < 0.01) and lower levels of risky drinking at 12 months postpartum compared to the control group (OR 0.45, 0.27 to 0.74, p < 0.002). The net incremental monetary benefit was not statistically significantly different between arms, although the probability of the intervention being cost-effective was above 60%, at policy-relevant thresholds. Conclusions There was no significant difference between groups on the primary outcome of BMI at 12 months. Analyses of secondary outcomes indicated improved healthy eating and lower levels of risky drinking. Trial registration: Current Controlled Trials ISRCTN25260464.

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