Endoscopic Characterization of Colorectal Neoplasia With the Different Published Classifications

Colorectal Neoplasia Clinical Trial

Official title:

Endoscopic Characterization of Colorectal Neoplasia With the Different Published Classifications: a Prospective Comparative Study Involving Gastroenterologists From Trainees to Experts.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04048447
• Other study ID #: SFED PROTOCOL
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: August 2019
• Source: Hôpital Edouard Herriot
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Endoscopic characterization is now essential in front of a colorectal lesion to predict its histology and choose the best therapeutic strategy. Different classifications have been proposed to predict histology depending on the endoscopic aspect. Thus, the aspect of the shape of the lesion is described in the Paris classification, the aspect of the mucosal pattern in Kudo's classification and the vascular pattern in Sano's one. Recently, classifications combining several color and mucosal and vascular pattern criteria have been described as the NICE classification or even more recently the Japanese JNET classification. However, although the interest in combining the Paris, Sano and Kudo criteria has recently shown its interest, there was not yet an overall classification covering all the published criteria. We have created a synthetic classification called CONECCT grouping the different criteria for an initial educational purpose. We have demonstrated that this tool allows interns and gastroenterologists to progress in the histological prediction of colorectal lesions presented in the form of photo files. Nevertheless, comparative data of the performances of those different classifications to predict the histology and the concordance intra and inter-observer have never been published. To validate this CONECCT classification, we created this comparative study evaluating the endoscopic characterization performances of these different classifications in terms of histological prediction and intra- and interobserver concordance in a group of gastroenterologists with varying levels of expertise in front of colorectal lesions presented in the form of photographic records.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2018
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• The participants were gastroenterologist doctors (experts, general or internal).

• Lesions presented were resected endoscopically after completion of a picture file.

• Pathology available for presented lesions.

• Participants signed informed consent and voluntarily participated in the characterization of these 206 lesions.

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Colorectal Neoplasia
• Neoplasms

Locations

Country	Name	City	State
France	Edouard Herriot Hospital	Lyon	Rhône Alpes

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Edouard Herriot

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the interobserver Concordance of the CONECCT classification compared to the 6 other existing ones		1 year