Clinical trial NCT02861885: Detection and Characterization of Sessile Serrated Lesions (SSL) of the Right Colon
Official title: Detection and Characterization of Sessile Serrated Lesions (SSL) of the Right Colon
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Neoplasm
Sessile Serrated Lesion
Neoplasms
Keywords: Colonoscopy
sessile serrated lesions
chromoendoscopy
narrow band imaging
Indigo Carmin®
Pit pattern
Kudo classification
NICE classification
neoplasms by histologic type
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


Eligibility criteria: 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.

Primary outcomes:
measure: patients with sessile serrated lesions
timeFrame: at colonoscopy day (Day 1)
Secondary outcomes:
measure: PARIS classification
timeFrame: at colonoscopy day (Day 1)
measure: Kudo's pit pattern classification
timeFrame: at colonoscopy day (Day 1)
measure: NICE classification
timeFrame: at colonoscopy day (Day 1)
measure: Specific mean of macroscopically detected SSL
timeFrame: at colonoscopy day (Day 1)
measure: SSL histologic characterization
timeFrame: histopathological results (up to 2 weeks)
measure: False positive
timeFrame: histopathological results (up to 2 weeks)
measure: False negative
timeFrame: histopathological results (up to 2 weeks)
measure: Detection techniques diagnosis performance
timeFrame: at colonoscopy day (Day 1)
measure: Detection techniques diagnosis performance
timeFrame: at colonoscopy day (Day 1)
measure: Detection techniques diagnosis performance
timeFrame: at colonoscopy day (Day 1)
measure: Detection techniques diagnosis performance
timeFrame: at colonoscopy day (Day 1)
measure: Detection techniques diagnosis performance
timeFrame: at colonoscopy day (Day 1)
measure: Detection techniques diagnosis performance
timeFrame: at colonoscopy day (Day 1) + histopathological results (up to 2 weeks)
Other outcomes:
Locations:
city: Clermont-ferrand
country: France
facility: Hôpital Estaing, CHU Clermont Ferrand, NHE Service d'Hépato-gastroentérologie, 1 place Lucie Aubrac
city: LYON cedex 04
country: France
facility: Hospices Civils de Lyon, Hôpital de la Croix Rousse, Service d'hépato-gastroentérologie, 103 Grande-Rue de la Croix Rousse
city: Lyon
country: France
facility: Centre Hospitalier Saint JOSEPH Saint Luc, Service d'hépato-gastroentérologie, 20 quai Claude Bernard
city: Lyon
country: France
facility: Hospices Civils de Lyon, Hôpital E Herriot, Service d'hépatogastroentérologie, 5 place d'Arsonval
city: Pierre Benite
country: France
facility: Hospices Civils de Lyon, Hôpital Lyon Sud, Service d'hépato-gastroentérologie, Chemin Grand Revoyet
city: Villefranche Sur Saone
country: France
facility: Centre Hospitalier Villefranche sur Saône, Service d'Hépato-gastroentérologie, Plateux d'Ouilly Gleize
Study officials:
affiliation: Hospices Civils de Lyon, Hôpital E Herriot, Service d'hépatogastroentérologie, 5 place d'Arsonval, 69437 LYON cedex 03, France
name: Christine CHAMBON-AUGOYARD, MD
role: PRINCIPAL_INVESTIGATOR
References: