Symptoms and General Pathology

All Conditions

Colonic Polyps

Polyps

Pathological Conditions, Anatomical

Intestinal Polyps

Approximately 35 endoscopists whom are certified to perform colonoscopies on FIT-positive patients in the Dutch population screening program

Colonoscopies on FIT-positive patients in the Dutch population screening program

Olympus colonoscopes with Narrow Band Imaging

3-monthly or no 3-monthly feedback on results of optical diagnosis

Feedback

Evelien Dekker, Prof. dr.

In this study, Dutch gastroenterologists who are certified for performing colonoscopies on FIT-positive patients in the Dutch population screening program are trained in optical diagnosis with validated methods. After this training, an ex- and in-vivo test phase leads to "accreditation" and endoscopists will be observed in their optical diagnosis for 1 year. During this year, half of the endoscopists will be randomized towards 3-monthly feedback and the other half will receive feedback on their results after 1 year. The endoscopic prediction of endoscopists on polyp histology will be compared to histopathological outcome.

Through the recently started nationwide bowel cancer screening programme in the Netherlands, an extra 70.000 colonoscopies are annually performed. In current practice, all resected colonic lesions are histopathologically analysed. Even diminutive polyps, which rarely harbour cancer or advanced histological features. If endoscopists are able to accurately differentiate between neoplastic and non-neoplastic lesions during colonoscopy, practice could become more efficient and costeffective. This strategy is called optical diagnosis and two clinical practice strategies have been proposed by the American Society of Gastroenterologists (ASGE). First, diminutive polyps could be resected and discarded if \>90% of the surveillance intervals predicted on optical diagnosis correlate with the surveillance intervals after histopathological validation (if assessed with high confidence). Second, hyperplastic polyps in the rectosigmoid could be left in situ if endoscopists are able to confidently predict neoplastic histology of diminutive colorectal polyps with a negative predictive value (NPV) of ≥90%.

The accuracy of white light colonoscopy is not acceptable for daily practice (59%-84%), but narrow band imaging (NBI) allows higher accuracies up to 98% and it was demonstrated that experienced endoscopists could reach a NPV of ≥90% for diminutive colorectal lesions. However, recent research shows that community gastroenterologists are not able to meet the quality thresholds proposed by the ASGE. Before this strategy could be safely applied in daily practice, community gastroenterologists should be able to meet thresholds as well.

In this study, Dutch gastroenterologists who are certified for performing colonoscopies on FIT-positive patients in the Dutch population screening program, are trained in optical diagnosis with validated methods. After training, an ex- and in-vivo test phase leads to "accreditation" and endoscopists will be observed in their optical diagnosis for 1 year. During this year, half of the endoscopists will be randomized towards 3-monthly feedback and the other half will receive feedback on their results after 1 year. The endoscopic prediction of endoscopists on polyp histology will be compared to histopathological outcome.

Implementation of Optical Diagnosis for Diminutive Polyps Amongst Endoscopists: Training and Long-term Quality Assurance

Implementation of Optical Diagnosis for Diminutive Polyps Amongst Accredited Endoscopists for the Dutch Bowel Cancer Screening Program: Training and Long-term Quality Assurance

Dutch Digestive Diseases Foundation

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

MD, PhD

Neoplasms

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

Two hour training session in interpretation and application of narrow band imaging technology

Education intervention: Training in Narrow Band Imaging

Colorectal cancer is the second leading cause of cancer related death in the United States. Colonoscopy is the most commonly performed screening procedure and diminutive polyps (\<5mm) are the most commonly found polyps during colonoscopy. Although these polyps have a very low risk of harboring malignancy, they are routinely removed to determine surveillance intervals.

Narrow Band Imaging is equipped on widely available colonoscopes and in expert hands can allow accurate real-time optical histologic diagnosis of colorectal polyps. If this practice can be applied widely, there is significant potential for cost savings.

This has led to a 'characterize, resect and discard' strategy where polyps determined to be hyperplastic (benign with no neoplastic potential) can be left in place and those determined to be adenomatous (have neoplastic potential) can be resected and discarded.

It is unclear if endoscopists without prior expertise or training in Narrow Band Imaging can achieve adequate diagnostic accuracy to put 'characterize, resect and discard' into wide practice.

Gastroenterologists without prior training in NBI from two affiliated academic hospitals will participate in an ex-vivo training session in which they will view a short audiovisual tool describing previously validated NBI criteria to determine polyp histology, followed by reviewing 80 videos of diminutive polyps under NBI and will record predicted polyp histology and degree of confidence. After each video, targeted feedback regarding actual polyp histology and NBI criteria supporting the diagnosis will be provided. Participants will then employ NBI in real-time colonoscopy (in-vivo) and record predicted polyp histology, degree of confidence and predicted surveillance intervals based on NBI interpretations. Each study polyp will be sent for histology separately. Performance will be assessed by comparing predicted histology with actual histology. Structured performance feedback will be given to promote practice-based learning, establish a real-time learning curve and determine the number of observations required to achieve competency in-vivo.

The primary aim of this study was to determine whether endoscopists with no prior experience or training in Narrow Band Imaging can achieve the thresholds set forth by the American Society of Gastrointestinal Endoscopy: For diminutive colorectal polyp diagnoses made with 'high-confidence,' a (1) greater than or equal to 90% negative predictive value in the rectosigmoid colon and a (2) greater than or equal to 90% agreement in surveillance intervals predicted by narrow band imaging and those based on the current gold standard of histology.

The secondary outcomes for the in-vivo phase included (1) evaluating overall group performance (accuracy, sensitivity, specificity, predictive values) of optical diagnoses using NBI based on degree of confidence and location within the colon, (2) evaluating individual performance on the ASGE benchmarks, (3) determining predictors of performance, and (4) determining real-time learning effect in the setting of ongoing, structured performance feedback. The secondary outcomes for the ex-vivo (training) phase included (1) evaluating overall performance by degree of confidence, (2) determining predictors of performance during training and (3) evaluating a learning effect in the setting of ongoing feedback during training.

Sample size was calculated to show an NPV of 90% or higher assuming that the true NPV is 95% for rectosigmoid polyps characterized with "high-confidence," based on 26 participating endoscopists and within-endoscopist correlation of 0.05. This will require 336 total rectosigmoid non-adenoma polyps characterized with "high-confidence," and assuming approximately 22% rectosigmoid polyps, 70% with high confidence and 80% hyperplastic, the study will require approximately 2,727 polyps and 1,364 colonoscopies in total, assuming approximately two polyps per colonoscopy.

Real-Time Characterizations of Diminutive Colorectal Polyps Using Narrow Band Imaging

Prospective Multi-Center Study Evaluating Real-Time Characterizations of Diminutive Colorectal Polyps Using Narrow Band Imaging: Implications for the Resect and Discard Strategy

University of Colorado, Denver

University of Michigan

Clinical Lecturer

Adenoma

Patients who have a colonoscopy in regular care as part of the Dutch colorectal screening program, in the context of complaints or in the context of the follow-up of previously diagnosed bowel diseases. And who have at least one colorectal polyp found and resected during the examination.

Optical diagnosis of colorectal polyps made with computer-aided diagnosis (CADx) using state-of-the-art machine learning methods and deep learning architectures.

Computer-aided diagnosis (CADx)

Optical diagnosis of colorectal polyps made with BLI Adenoma Serrated International Classification (BASIC), both by exert endoscopists and novices.

BLI Adenoma Serrated International Classification (BASIC)

Ad Masclee, Prof. Dr.

Primary, this study aims to develop and validate a computer-aided diagnosis (CADx) system for the characterization of colorectal polyps.

Second, this study evaluates the effect of using a clinical classification model Blue Light Imaging Adenoma Serrated International (BASIC) on the diagnostic accuracy of the optical diagnosis of colorectal polyps compared to intuitive optical diagnosis for both expert endoscopists and novices.

Optical diagnosis of colorectal polyps, the in-vivo characterization of the histology by endoscopists, is of increasing interest for clinical endoscopy practice. Recent studies have shown that thresholds for optical diagnosis are met in highly selected groups of expert endoscopists, but the same is not true in community endoscopy practices. In order to improve optical diagnosis, imaging enhancement techniques and the use of artificial intelligence are proposed.

This observational study developes a computer-aided diagnosis (CADx) system to differentiate between benign and (pre-)malignant CRPs, using state-of-the-art machine learning methods and deep learning architectures. For the development, HDWL and BLI images are used. The CADx is trained using histology as gold standard. The CADx is externally validated using on a set of 60 colorectal polyps. This study will evaluate if the optical diagnosis of colorectal polyps can be improved with the aid of CADx.

In addition, both expert endoscopists and novices optically diagnose the colorectal polyps. In the first, pre-training phase, endoscopists optically diagnose colorectal polyps based on intuition. Afterwards, in the post-training phase, the same set of colorectal polyps is optically diagnosed based on a clinical classification system; BLI Adenoma Serrated International Classification (BASIC). This study will evaluate if the optical diagnosis of colorectal polyps can be improved with the aid of BASIC in both expert and non-expert hands.

Colorectal polyps are resected for histological evaluation. This specimen is resected because of regular care, not for study purposes.

Improving Optical Diagnosis of Colorectal Polyps Using CADx and BASIC.

Improving Optical Diagnosis of Colorectal Polyps Using Computer-aided Diagnosis (CADx) and the BLI Adenoma Serrated International Classification (BASIC).

At this moment, there is no plan to share individual participant data.

The diagnostic accuracy of characterizing colorectal polyps (into benign versus (pre-)malignant) made by CADx in comparison to the diagnostic accuracy of both expert endoscopists and novices. In which histology is the gold standard.

The diagnostic accuracy of both expert endoscopists and novices in characterizing colorectal polyps (into hyperplastic polyp, adenoma, sessile serrated adenoma, or adenocarcinoma) based on the clinical classification model BASIC, in comparison to the diagnostic accuracy based on intuition. In which histology is the gold standard.

The sensitivity, specificity, negative and positive predictive value of characterizing colorectal polyps (into benign versus (pre-)malignant) made by CADx.

Area Under ROC Curve (AUC) of CADx for characterizing colorectal polyps (into benign versus (pre-)malignant) made by CADx.

The sensitivity, specificity, negative and positive predictive value of characterizing colorectal polyps (into hyperplastic polyp, adenoma, sessile serrated adenoma, or adenocarcinoma) of both expert endoscopists and novices.

The diagnostic accuracy, sensitivity, specificity, negative and positive predictive value of both expert endoscopists and novices for optical diagnosis made with high (\>90%) confidence.

The interobserver agreement of experts, novices and CADx for characterizing colorectal polyps.

The computation time per image of CADx for characterizing colorectal polyps.

Catharina Ziekenhuis Eindhoven

Eindhoven University of Technology

Maastricht University Medical Center

Gastroenterologists participating in the e-learning module

Gastroenterologists not participating in the e-learning module

The intervention is a structured e-learning module on a web-based platform (www.trainingopticaldiagnosis.com) that consists of:

* 10 modules, including theoretical knowledge and multiple exercises.
* 2 seminars with a tutor (after Module 5 and Module 10)
* feedback from the tutor on three cases recorded by the participant.
* 20-images test before and after the content described above (10 Modules, 2 seminars with tutors and feedback on three cases)

All the Gastroenterologists participating in the study will predict deep submucosal invasion in their routine colonoscopies and will register clinical outcomes during 12 months. The randomisation and intervention will be conducted 6 months after starting to predict deep submucosal invasion and registering clinical outcomes.

E-learning module

Anna Arnau, PhD

Anna Cano, BAJ

Ignasi Puig del Castillo, MD, PhD

Anna Cano-Català, BAJ

Ignasi Puig, MD, PhD

Marco Antonio Álvarez, MD, PhD

Ignasi Puig, PhD

International guidelines recommend deciding the treatment of colorectal lesions based on the estimated histology by endoscopic optical diagnosis. However, the theoretical and practical knowledge on optical diagnosis is not widely expanded

The mail goal of this randomised controlled trial is to compare the pooled sensitivity of optical diagnosis for predicting deep submucosal invasion in large non-pedunculated polyps \> 20 mm assessed in routine colonoscopies of gastroenterologists attending a e-learning module (intervention group) vs gastroenterologists who do not (control group)

The main questions the study aims to answer are:

* Is the pooled sensitivity of optical diagnosis for predicting deep submucosal invasion in large non-pedunculated polyps assessed in routine colonoscopies increased in those gastroenterologists participating in the e-learning module?
* Is the pooled diagnostic accuracy of optical diagnosis for predicting deep sm invasion in large non-pedunculated polyps ≥ 20 mm assessed in routine colonoscopies increased in those gastroenterologists participating in the e-learning module?
* In lesions with submucosal invasion, is the en bloc and complete resection rate (R0) increased in those gastroenterologists participating in the e-learning module?
* In lesions referred to surgery, is the pooled benign polyps rate decreased in those gastroenterologists participating in the e-learning module?
* In lesions treated with advanced en bloc procedures (ESD, TAMIS, fullthickness resection), is the pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion increased in those gastroenterologists participating in the e-learning module?
* In lesions treated with piecemeal endoscopic resection, is the pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion decreased in those gastroenterologists participating in the e-learning module?
* Is the diagnostic accuracy for predicting deep submucosal invasion in a test with pictures increased after participating in the e-learning module?

The participants (or subjects of study) are gastroenterologists. They will be randomised to do the e-learning course (intervention group) or not (control group).

Researchers will compare clinical outcomes of gastroenterologists participating in the e-learning module vs gastroenterologists not participating in the e-learning module to see if:

* the pooled sensitivity of optical diagnosis for predicting deep submucosal invasion in large non-pedunculated polyps \> 20 mm assessed in routine colonoscopies is increased.
* the pooled diagnostic accuracy of optical diagnosis for predicting deep sm invasion in large non-pedunculated polyps \> 20 mm is increased.
* the en bloc and complete resection rate (R0) is increased in lesions with submucosal invasion.
* the pooled benign polyps rate decreased in lesions referred to surgery.
* the pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion increased in lesions treated with advanced en bloc procedures (ESD, TAMIS, fullthickness resection).
* the pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion decreased in lesions treated with piecemeal endoscopic resection.
* the diagnostic accuracy for predicting deep submucosal invasion in a test with pictures after participating is increased.

Non-pharmacological multi-centre randomised controlled trial. Gastroenterologists who have performed \> 300 colonoscopies without supervision and who have finished/will finish the residency in Gastroenterology between 2014 and 2023 will be invited to participate. Gastroenterologists participating in the study will register the optical diagnosis, endoscopic lesions' characteristics, histology and clinical outcomes of consecutive non-pedunculated lesions ≥ 20 mm found in routine colonoscopies during a whole year. Participants allocated in the intervention group will receive a learning module after six months. Those assigned in the control group will not receive any learning module (they will be offered to do it at the end of the study). Pooled sensitivity and diagnostic accuracy of optical diagnosis for predicting deep submucosal invasion, and clinical outcomes in routine colonoscopies will be compared in both groups. Diagnostic accuracy for predicting deep submucosal invasion in a test with pictures before and after participating will also be compared.

Non-pharmacological multi-centre, stratified (by the centre and experience, with balance randomisation \[1:1\]), randomised, controlled, parallel trial conducted in Spain.

Web-based Learning Module on Optical Diagnosis of Early Colorectal Cancer

Web-based Learning Module to Increase the Accuracy of Optical Diagnosis for Detecting the Invasive Pattern of Colorectal Polyps (LODIP Study). Randomised Controlled Trial

Pooled sensitivity of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies.

Pooled Sensitivity of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies.

Pooled Specificity of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies.

Pooled ROC area of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies.

Pooled PPV of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies.

Pooled NPV of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies.

Pooled LR+ of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies.

Pooled LR- of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies.

Pooled en bloc resection rate in polyps containing submucosal invasion found in routine colonoscopies

Pooled complete resection rate (R0) according to the pathologist criteria in polyps containing submucosal invasion

Pooled benign polyps rate in lesions refered to surgery

Pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion in lesions treated with advanced en bloc procedures (ESD, TAMIS, fullthickness resection)

Pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion in lesions treated with piecemeal endoscopic resection

Pooled Sensitivity of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group

Pooled Specificity of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group

Pooled ROC area of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group

Pooled PPV of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group

Pooled NPV of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group

Pooled LR+ of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group

Pooled LR- of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Implementation of Optical Diagnosis for Diminutive Polyps Amongst Endoscopists: Training and Long-term Quality Assurance	NCT02407925	Colonoscopy Colonic Polyps	Feedback	55 Years - 75 Years	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Real-Time Characterizations of Diminutive Colorectal Polyps Using Narrow Band Imaging	NCT02441998	Colorectal Canc...	Education inter...	-	University of Michigan
Improving Optical Diagnosis of Colorectal Polyps Using CADx and BASIC.	NCT04349787	Colorectal Canc... Colorectal Poly...	Computer-aided ... BLI Adenoma Ser...	18 Years -	Maastricht University Medical Center
Web-based Learning Module on Optical Diagnosis of Early Colorectal Cancer	NCT05663788	Colorectal Canc... Colorectal Canc...	E-learning modu...	28 Years -	Althaia Xarxa Assistencial Universitària de Manresa
Real-Time Characterizations of Diminutive Colorectal Polyps Using Narrow Band Imaging	NCT02441998	Colorectal Canc...	Education inter...	-	University of Michigan
Implementation of Optical Diagnosis for Diminutive Polyps Amongst Endoscopists: Training and Long-term Quality Assurance	NCT02407925	Colonoscopy Colonic Polyps	Feedback	55 Years - 75 Years	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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