Development of a New Simplified Tool to Predict LNPCPs Histology and Assess the Risk of Submucosal Invasive Cancer. The Colorectal Regular-Irregular Score

Summary

Colorectal cancer (CRC) is the third most common malignancy worldwide and the second leading cause of cancer related death. It can be prevented by endoscopic detection and complete resection of colorectal polyps. The JNET (Japanese NBI Expert Team) classification is clinically useful to predict the histology of large non-pedunculated colorectal polyps (LNPCPs) using narrow-band imaging at endoscopy. Japanese experts can reliably predict histology including the presence and depth of submucosal invasive cancer (SMI) using JNET with accuracy \>87%. On the other hand, the International Evaluation of Endoscopy classification-JNET (IEE-JNET) group demonstrated that ESGE and JGES endoscopists had sufficient accuracy for JNET 1 (93.0%) but insufficient accuracy for JNET 2A/B and 3 (respectively 62.1%, 55.1% and 85.1%). Reliably distinguishing between JNET 2A, 2B and 3 has a profound clinical relevance, since JNET 2A lesions can safely be resected using pEMR whereas JNET 2B lesions should be resected en-bloc (EMR or ESD) due to the increased risk of cancer and JNET 3 lesions are preferably treated with surgery due to the high risk of deeply invasive carcinoma and the necessity of lymph node resection.

This study aims to validate a new simplified score, the Colorectal Regular-Irregular Score (CRIS) to fulfill the urgent need for a more effective and easier to use tool to predict LNPCPs histology. CRIS is a simplification of the JNET score which is mainly used by Japanese endoscopists or experts, recent evidence suggests its accuracy when used in everyday endoscopy in the Western world is insufficient. The investigators aim to compare JNET with CRIS for LNPCPs histology prediction amongst Western endoscopists using both original JNET interpretation and a clinically relevant approach.

The study consists of three work packages (WPs):

Work package one involves an expert online study where twelve expert endoscopists will evaluate 32 high-quality images of colorectal polyps using both JNET and CRIS classifications. Work package two involves an image/video-based online study where non-expert participants will be randomly assigned to rate images and videos using either JNET or CRIS, with performance re-evaluated after three months. Work package three involves a clinical study in a live endoscopy environment where non-expert endoscopists will participate in a randomized controlled trial assessing 10 colorectal polyps using either JNET or CRIS.

Conditions

• Colorectal Cancer

Interventions

OTHER

Learning tool (CRIS/JNET)

Participants will follow a 5-minute learning video (intervention) on CRIS and later for JNET.

OTHER

Learning tool (JNET/CRIS)

Participants will follow a 5-minute learning video (intervention) on JNET and later for CRIS.

Sponsors & Collaborators

• University Hospital, Ghent

  lead OTHER

Principal Investigators

• David Tate · University Hospital, Ghent

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2028-12-31

Completion

2028-12-31

Countries

• Belgium

Study Locations