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

NCT02861885 | Unknown

• 1 other identifier: 69HCL16_0158
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 6

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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• PARIS classification

  at colonoscopy day (Day 1)

• Kudo's pit pattern classification

  at colonoscopy day (Day 1)

• NICE classification

  at colonoscopy day (Day 1)

• Specific mean of macroscopically detected SSL

  at colonoscopy day (Day 1)

• SSL histologic characterization

  histopathological results (up to 2 weeks)

Study Arms (1)

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

Interventions

Chromoendoscopy OTHER

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.

Lesion SSL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• st 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (6)

Hôpital Estaing, CHU Clermont Ferrand, NHE Service d'Hépato-gastroentérologie, 1 place Lucie Aubrac

Clermont-Ferrand, 63003, France

Location

Centre Hospitalier Saint JOSEPH Saint Luc, Service d'hépato-gastroentérologie, 20 quai Claude Bernard

Lyon, 69004, France

Location

Hospices Civils de Lyon, Hôpital de la Croix Rousse, Service d'hépato-gastroentérologie, 103 Grande-Rue de la Croix Rousse

Lyon, 69317, France

Location

Hospices Civils de Lyon, Hôpital E Herriot, Service d'hépatogastroentérologie, 5 place d'Arsonval

Lyon, 69437, France

Location

Hospices Civils de Lyon, Hôpital Lyon Sud, Service d'hépato-gastroentérologie, Chemin Grand Revoyet

Pierre-Bénite, 69310, France

Location

Centre Hospitalier Villefranche sur Saône, Service d'Hépato-gastroentérologie, Plateux d'Ouilly Gleize

Villefranche-sur-Saône, 69655, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms; Neoplasms by Histologic Type

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Christine CHAMBON-AUGOYARD, MD

  Hospices Civils de Lyon, Hôpital E Herriot, Service d'hépatogastroentérologie, 5 place d'Arsonval, 69437 LYON cedex 03, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 10, 2016
• Study Start: February 24, 2016
• Primary Completion: April 24, 2022
• Study Completion: April 24, 2022
• Last Updated: March 21, 2022

Record last verified: 2022-03

Locations

FR (6)