Detection and Characterization of Sessile Serrated Lesions (SSL) of the Right Colon

• Conditions: Sessile Serrated Lesion; Neoplasms; Colorectal Neoplasm
• Interventions: Other: Chromoendoscopy

• Registration Number: NCT02861885
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

There are a few studies regarding Sessile Serrated Lesions (SSL). They are recently identified as precancerous lesions. Yet, digestive tract serrated lesions would be part of a new colic carcinogenesis way : the serrated tumor way. Evolution from polyp to cancer would be faster than through the usual adenoma to cancer way. It would be then responsible of a lot of "missed" lesions or interval cancer. The missed SSL rate is estimated at between 27% and 59%.

Current diagnosis methods show weakness to identify those SSL. In order to improve their detection, the investigators dispose of several coloration techniques. Indigo carmine chromoendoscopy enhance neoplastic lesion detection as part of the hereditary rectal carcinoma screening. NBI electronic coloration, which is faster and easier has not shown any efficacy on the adenoma detection rate, except for patients with Lynch syndrome.

The objective is to better describe the SSL endoscopic semiology (detection and characterization) and to establish standards for the endoscopic techniques in order to improve the colonoscopy diagnosis quality. The investigators propose to evaluate 2 fundamental endoscopic techniques (Narrow Band Imaging (NBI) and indigo carmine), widely used for other indications, in comparison with the White Light technique (WLI).

Therefore, the investigators propose a prospective, observational, multicentric cohort study in order to 1) define SSL endoscopic various aspects 2) establish which technique (white light, Narrow Band Imaging, indigo carmine chromoendoscopy) is the best to diagnose SSL, namely detection and characterization 3) evaluate the multifocal dimension rate for those lesions at ascending colon level.

The diagnosis impact is immediate, and could allow to consider an update for boh endoscopic NICE and Kudo Pit Pattern classification, and good practice guidances for colonoscopic diagnosis. Better SSL detectability thus their systematic resection could have a long term effect in reducing both colon cancer rate and interval cancer

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-24
• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-08-09
• Study First Posted: 2016-08-10
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-18
• Last Update Posted: 2022-03-21
• Primary Completion: 2022-04-24
• Study Completion: 2022-04-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• Male or female patients 18 years of age or older
• Patient having an indication for colonoscopy to detect colorectal neoplastic lesions, which meet at least one of the following conditions :
• Positive fecal occult blood test
• 1st degree family history of colorectal cancer or adenoma before 60 years of age
• Personal history of colorectal adenoma or colorectal cancer
• Unexplained digestive symptoms after 50 years of age or those not responding to symptomatic treatment : modification of bowel movements, abdominal pains
• Isolated or repeated rectal bleeding after 50 years of age or occult bleeding
• Acromegaly
• Infectious endocarditis with digestive bacteria
• Suspicion of sessile serrated lesion in the right colon
• None opposite of patient for participating

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Exclusion Criteria

• History of digestive resection as resection of the right colon (right ileocolectomy, right hemicolectomy) or large colic resection.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lesion SSL	Chromoendoscopy	Patient cohort referred by colonoscopy screening indication, digestive syndrome or monitoring, with ascendant colon macroscopic SSL suspicion throughout white light during colonoscopy

Primary Outcome Measures

Name	Time	Method
patients with sessile serrated lesions	at colonoscopy day (Day 1)	Proportion of patient for whom at least one new SSL has been shown macroscopically through NBI and/or indigo carmine chromoendoscopy but not detected with WLI

Secondary Outcome Measures

Name	Time	Method
PARIS classification	at colonoscopy day (Day 1)	All SSL will be characterized using the PARIS classification of colorectal polyps
Specific mean of macroscopically detected SSL	at colonoscopy day (Day 1)	Comparison of the mean number of SSL per technique (white light, Narrow Band Imaging, indigo carmine chromoendoscopy)
False negative	histopathological results (up to 2 weeks)	Number of polyps not identified as SSL, but reclassified by histological results
False positive	histopathological results (up to 2 weeks)	Number of suspected SSL macroscopically but unconfirmed histologically
Kudo's pit pattern classification	at colonoscopy day (Day 1)	All SSL will be characterized using the Kudo's pit pattern classification for colorectal neoplasms
SSL histologic characterization	histopathological results (up to 2 weeks)	All SSL will be characterized using the Vienna classification of gastrointestinal epithelial neoplasia
NICE classification	at colonoscopy day (Day 1)	All SSL will be characterized using the Narrow band imaging International Colorectal Endoscopic (NICE) of small colorectal polyps.
Detection techniques diagnosis performance	at colonoscopy day (Day 1) + histopathological results (up to 2 weeks)	Proportion of macroscopically suspected SSL by the endoscopist and confirmed as SSL with histological results from expert center (false negative)

Trial Locations

Locations (6)

Hôpital Estaing, CHU Clermont Ferrand, NHE Service d'Hépato-gastroentérologie, 1 place Lucie Aubrac; 🇫🇷 Clermont-ferrand, France

Hospices Civils de Lyon, Hôpital de la Croix Rousse, Service d'hépato-gastroentérologie, 103 Grande-Rue de la Croix Rousse; 🇫🇷 LYON cedex 04, France

Centre Hospitalier Saint JOSEPH Saint Luc, Service d'hépato-gastroentérologie, 20 quai Claude Bernard; 🇫🇷 Lyon, France

Hospices Civils de Lyon, Hôpital E Herriot, Service d'hépatogastroentérologie, 5 place d'Arsonval; 🇫🇷 Lyon, France

Centre Hospitalier Villefranche sur Saône, Service d'Hépato-gastroentérologie, Plateux d'Ouilly Gleize; 🇫🇷 Villefranche Sur Saone, France

Hospices Civils de Lyon, Hôpital Lyon Sud, Service d'hépato-gastroentérologie, Chemin Grand Revoyet; 🇫🇷 Pierre Benite, France