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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Neoplasms; Colorectal Neoplasm; Sessile Serrated Lesion
• Intervention / Treatment: Other: Chromoendoscopy

• Study Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• France
  • Clermont-ferrand, France, 63003
    • Hôpital Estaing, CHU Clermont Ferrand, NHE Service d'Hépato-gastroentérologie, 1 place Lucie Aubrac
  • LYON cedex 04, France, 69317
    • Hospices Civils de Lyon, Hôpital de la Croix Rousse, Service d'hépato-gastroentérologie, 103 Grande-Rue de la Croix Rousse
  • Lyon, France, 69004
    • Centre Hospitalier Saint JOSEPH Saint Luc, Service d'hépato-gastroentérologie, 20 quai Claude Bernard
  • Lyon, France, 69437
    • Hospices Civils de Lyon, Hôpital E Herriot, Service d'hépatogastroentérologie, 5 place d'Arsonval
  • Pierre Benite, France, 69310
    • Hospices Civils de Lyon, Hôpital Lyon Sud, Service d'hépato-gastroentérologie, Chemin Grand Revoyet
  • Villefranche Sur Saone, France, 69655
    • Centre Hospitalier Villefranche sur Saône, Service d'Hépato-gastroentérologie, Plateux d'Ouilly Gleize

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The population being studied is the cohort of patients referred for a colonoscopy resulting screening indication, digestive syndrome or monitoring.

Description

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Other: Chromoendoscopy; Colonoscopy will run in accordance with standard procedure, including air insufflation throughout the endoscope rise. The endoscope will be a Olympus NBI videoscope (180 series and latest). First, progression will run until caecum without systematic terminal ileum intubation. Polyps will be searched out during descent phase. The patient will be eligible as soon as the operator suspects an ascendant colon SSL with white light. The operator will have to initiate the WLI colonoscopy. If a SSL is suspected in the colon, the operator will run at the same time, a NBI colon examination, then an indigo carmine chromoendoscopy colon examination. Each lesion will be pictured before and after mucus clean-up. Lesions biopsy or resection will be ran in accordance with standard procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patients with sessile serrated lesions	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	at colonoscopy day (Day 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PARIS classification	All SSL will be characterized using the PARIS classification of colorectal polyps	at colonoscopy day (Day 1)
Kudo's pit pattern classification	All SSL will be characterized using the Kudo's pit pattern classification for colorectal neoplasms	at colonoscopy day (Day 1)
NICE classification	All SSL will be characterized using the Narrow band imaging International Colorectal Endoscopic (NICE) of small colorectal polyps.	at colonoscopy day (Day 1)
Specific mean of macroscopically detected SSL	Comparison of the mean number of SSL per technique (white light, Narrow Band Imaging, indigo carmine chromoendoscopy)	at colonoscopy day (Day 1)
SSL histologic characterization	All SSL will be characterized using the Vienna classification of gastrointestinal epithelial neoplasia	histopathological results (up to 2 weeks)
False positive	Number of suspected SSL macroscopically but unconfirmed histologically	histopathological results (up to 2 weeks)
False negative	Number of polyps not identified as SSL, but reclassified by histological results	histopathological results (up to 2 weeks)
Detection techniques diagnosis performance	Proportion of macroscopically suspected SSL by one of the 3 techniques (white light, Narrow Band Imaging, indigo carmine chromoendoscopy) and confirmed by centralized review (macro true positive)	at colonoscopy day (Day 1)
Detection techniques diagnosis performance	Proportion of macroscopically suspected SSL by one of the 3 techniques (white light, Narrow Band Imaging, indigo carmine chromoendoscopy) but not confirmed by centralized review (macro false positive)	at colonoscopy day (Day 1)
Detection techniques diagnosis performance	Proportion of macroscopically not suspected SSL by one of the 3 techniques (white light, Narrow Band Imaging, indigo carmine chromoendoscopy) and yet seen by centralized review (macro false negative)	at colonoscopy day (Day 1)
Detection techniques diagnosis performance	Proportion of macroscopically suspected SSL by one of the 3 techniques (white light, Narrow Band Imaging, indigo carmine chromoendoscopy) and confirmed by expert center (true positive)	at colonoscopy day (Day 1)
Detection techniques diagnosis performance	Proportion of macroscopically suspected SSL by one of the 3 techniques (white light, Narrow Band Imaging, indigo carmine chromoendoscopy) but not confirmed by centralized review (false positive)	at colonoscopy day (Day 1)
Detection techniques diagnosis performance	Proportion of macroscopically suspected SSL by the endoscopist and confirmed as SSL with histological results from expert center (false negative)	at colonoscopy day (Day 1) + histopathological results (up to 2 weeks)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Christine CHAMBON-AUGOYARD, MD, Hospices Civils de Lyon, Hôpital E Herriot, Service d'hépatogastroentérologie, 5 place d'Arsonval, 69437 LYON cedex 03, France

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2016
• Primary Completion (Anticipated): April 24, 2022
• Study Completion (Anticipated): April 24, 2022

Study Registration Dates

• First Submitted: August 2, 2016
• First Submitted That Met QC Criteria: August 9, 2016
• First Posted (Estimate): August 10, 2016

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Colonoscopy; narrow band imaging; chromoendoscopy; NICE classification; sessile serrated lesions; Indigo Carmin®; Pit pattern; Kudo classification; neoplasms by histologic type
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplasms; Colorectal Neoplasms
• Other Study ID Numbers: 69HCL16_0158