Prospective Assessment of CONECCT's Classification for Colorectal Lesions.

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT05983315
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Colorectal neoplastic lesion endoscopic characterization is a key element for histological predictive diagnostic value in conducting best appropriate resection choice. Six classifications are necessary for fully correct characterization of different colorectal lesions. Nonetheless, it can be tricky to use so many diagnostic tools with so many subcategories in the 6 existing classifications. That's why we decided to integrate all 6 existing classification validated factors in one single chart (CONECCT chart) allowing to both predict histological diagnostic value and to propose the best appropriate resection strategy. A previous prospective and multicentre study with all French medical residents in gastroenterology was conducted in order to prove pedagogic interest of this diagnostic tool. Each student was asked to review 20 files with lesion pictures before and after lecture about CONECCT chart. This allowed us to prove that this diagnostic tool could significantly improve both histological predictive diagnostic value and therapeutic choice by French medical residents and gastroenterologists. Our hypothesis is that CONECCT's classification can improve predictive diagnostic value of colorectal lesions in over 80% of cases. Now that pedagogic interest of this diagnostic tool has been proven, we would like to carry out a larger prospective assessment in term of performance (value) of this instrument in order to both facilitate endoscopic characterization and allow a most appropriate diagnostic and therapeutic management of each colorectal lesion category.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Primary Completion: 2022-07-01
• Study Completion: 2022-11-01
• Status Verified: 2023-08
• Study First Submitted: 2023-08-01
• Study First Submitted QC: 2023-08-01
• Last Update Submitted: 2023-08-01
• Study First Posted: 2023-08-09
• Last Update Posted: 2023-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between endoscopic CONECCT's classification	Time point can be reached either 2 weeks after endoscopic resection at V1 or between 2-4 months later in case of surgery at V3	assessed by one of research site operators and final histology reading of neoplastic lesion by anatomopathologist: * CONECCT 0E : neuroendocrine tumor; * CONECCT IH : hyperplastic polyp; * CONECCT IS : sessile serrated lesion with or without dysplasia; * CONECCT IIA : low or high grade adenoma; * CONECCT IIC : low or high grade adenoma or intramucosal or submucosal \<1000 micron adenocarcinoma; * CONECCT III : deep invasive submucosal \> 1000 microns adenocarcinoma

Trial Locations

Locations (1)

Hôpital Edouard Herriot; 🇫🇷 Lyon, France