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

Neoplasms Clinical Trial

— Lesion SSL  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02861885
• Other study ID #: 69HCL16_0158
• Status: Active, not recruiting
• Start date: February 24, 2016
• Est. completion date: April 24, 2022

Study information

• Verified date: March 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 71
• Est. completion date: April 24, 2022
• Est. primary completion date: April 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasm
• Colorectal Neoplasms
• Neoplasms
• Sessile Serrated Lesion

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Estaing, CHU Clermont Ferrand, NHE Service d'Hépato-gastroentérologie, 1 place Lucie Aubrac	Clermont-ferrand
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	Hospices Civils de Lyon, Hôpital de la Croix Rousse, Service d'hépato-gastroentérologie, 103 Grande-Rue de la Croix Rousse	LYON cedex 04
France	Hospices Civils de Lyon, Hôpital Lyon Sud, Service d'hépato-gastroentérologie, Chemin Grand Revoyet	Pierre Benite
France	Centre Hospitalier Villefranche sur Saône, Service d'Hépato-gastroentérologie, Plateux d'Ouilly Gleize	Villefranche Sur Saone

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PARIS classification	All SSL will be characterized using the PARIS classification of colorectal polyps	at colonoscopy day (Day 1)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	SSL histologic characterization	All SSL will be characterized using the Vienna classification of gastrointestinal epithelial neoplasia	histopathological results (up to 2 weeks)
Secondary	False positive	Number of suspected SSL macroscopically but unconfirmed histologically	histopathological results (up to 2 weeks)
Secondary	False negative	Number of polyps not identified as SSL, but reclassified by histological results	histopathological results (up to 2 weeks)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)