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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02861885

Collaborator

(none)

Enrollment

Locations

Anticipated Duration (Months)

11.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Colorectal Neoplasm Sessile Serrated Lesion Neoplasms	Other: Chromoendoscopy

Study Design

Study Type:

Observational

Actual Enrollment :

71 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 24, 2016

Anticipated Primary Completion Date :

Apr 24, 2022

Anticipated Study Completion Date :

Apr 24, 2022

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

PARIS classification [at colonoscopy day (Day 1)]
All SSL will be characterized using the PARIS classification of colorectal polyps
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
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.
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)
SSL histologic characterization [histopathological results (up to 2 weeks)]
All SSL will be characterized using the Vienna classification of gastrointestinal epithelial neoplasia
False positive [histopathological results (up to 2 weeks)]
Number of suspected SSL macroscopically but unconfirmed histologically
False negative [histopathological results (up to 2 weeks)]
Number of polyps not identified as SSL, but reclassified by histological results
Detection techniques diagnosis performance [at colonoscopy day (Day 1)]
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)
Detection techniques diagnosis performance [at colonoscopy day (Day 1)]
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)
Detection techniques diagnosis performance [at colonoscopy day (Day 1)]
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)
Detection techniques diagnosis performance [at colonoscopy day (Day 1)]
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)
Detection techniques diagnosis performance [at colonoscopy day (Day 1)]
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)
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

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