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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Artificial Intelligence for Diminutive Polyp Characterization

NCT05391477

Colorectal Neoplasms

UNKNOWN NA

A Study Comparing Standard and AI-Assisted Colonoscopies for Detecting and Characterizing Colorectal Lesions in Adults Aged 50-74 Undergoing Cancer Screening

NCT07125300

Colorectal Neoplasms Colorectal Cancer Adenoma Colon Polyp

COMPLETED NA

Early Diagnosis of Colorectal Cancer Based on a Non-invasive Metabolomics Profile

NCT06452745

Colorectal Cancer Colorectal Adenoma Colorectal Polyp +1 more

RECRUITING

Observational Cross-reactivity Study for Colorectal Cancer Diagnosis

NCT06889844

Colorectal Cancer

RECRUITING

Clinical Validation of PolyDeep: an Artificial Intelligence-based Computer-aided Polyp Detection (CADe) and Characterization (CADx) System. Polydeep Advance 3

NCT05513261

Colorectal Cancer

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer Colorectal Cancer Stage I

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

E-learning module gastroenterologists

Gastroenterologists participating in the e-learning module

Group Type EXPERIMENTAL

E-learning module

Intervention Type OTHER

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.

Control group

Gastroenterologists not participating in the e-learning module

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Gastroenterologists who have performed \> 300 colonoscopies without supervision and are in the last training year or had finished the Gastroenterology residency after 2014.

Exclusion Criteria

* Endoscopists who have learned the invasive pattern in a centre where endoscopists have published a high diagnostic accuracy for predicting deep submucosal invasion (Japanese centres).

Minimum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ignasi Puig

Gastroenterology Consultant, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ignasi Puig, PhD

Role: PRINCIPAL_INVESTIGATOR

Althaia Xarxa Assistencial Universitària de Manresa

Locations

Explore where the study is taking place and check the recruitment status at each participating site.