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

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ClinicalTrials.gov Identifier: NCT02861885
Recruitment Status : Recruiting
First Posted : August 10, 2016
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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
Colorectal Neoplasm Sessile Serrated Lesion Neoplasms Other: Chromoendoscopy

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Study Type : Observational
Estimated Enrollment : 300 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 : February 24, 2016
Estimated Primary Completion Date : June 24, 2021
Estimated Study Completion Date : June 24, 2021

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.




Primary Outcome Measures :
  1. patients with sessile serrated lesions [ Time Frame: 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 :
  1. PARIS classification [ Time Frame: at colonoscopy day (Day 1) ]
    All SSL will be characterized using the PARIS classification of colorectal polyps

  2. Kudo's pit pattern classification [ Time Frame: at colonoscopy day (Day 1) ]
    All SSL will be characterized using the Kudo's pit pattern classification for colorectal neoplasms

  3. NICE classification [ Time Frame: at colonoscopy day (Day 1) ]
    All SSL will be characterized using the Narrow band imaging International Colorectal Endoscopic (NICE) of small colorectal polyps.

  4. Specific mean of macroscopically detected SSL [ Time Frame: at colonoscopy day (Day 1) ]
    Comparison of the mean number of SSL per technique (white light, Narrow Band Imaging, indigo carmine chromoendoscopy)

  5. SSL histologic characterization [ Time Frame: histopathological results (up to 2 weeks) ]
    All SSL will be characterized using the Vienna classification of gastrointestinal epithelial neoplasia

  6. False positive [ Time Frame: histopathological results (up to 2 weeks) ]
    Number of suspected SSL macroscopically but unconfirmed histologically

  7. False negative [ Time Frame: histopathological results (up to 2 weeks) ]
    Number of polyps not identified as SSL, but reclassified by histological results

  8. Detection techniques diagnosis performance [ Time Frame: 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)

  9. Detection techniques diagnosis performance [ Time Frame: 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)

  10. Detection techniques diagnosis performance [ Time Frame: 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)

  11. Detection techniques diagnosis performance [ Time Frame: 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)

  12. Detection techniques diagnosis performance [ Time Frame: 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)

  13. Detection techniques diagnosis performance [ Time Frame: 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861885


Contacts
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Contact: Christine CHAMBON-AUGOYARD, MD (0)472 110 130 ext +33 christine.chabom-augoyard@chu-lyon.fr
Contact: Laurent MAGAUD, Clinical project manager (0)472 112 805 ext +33 laurent.magaud@chu-lyon.fr

Locations
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France
Hôpital Estaing, CHU Clermont Ferrand, NHE Service d'Hépato-gastroentérologie, 1 place Lucie Aubrac Not yet recruiting
Clermont-ferrand, France, 63003
Contact: Julien SCANZI, MD       jscanzi@chu-clermontferrand.fr   
Hospices Civils de Lyon, Hôpital de la Croix Rousse, Service d'hépato-gastroentérologie, 103 Grande-Rue de la Croix Rousse Recruiting
LYON cedex 04, France, 69317
Contact: Jean-Christophe SOUQUET, Pr         
Contact       jean-christophe.souquet@chu-lyon.fr   
Centre Hospitalier Saint JOSEPH Saint Luc, Service d'hépato-gastroentérologie, 20 quai Claude Bernard Not yet recruiting
Lyon, France, 69004
Contact: Denis PÉRÉ-VERGÉ, MD       dpereverge@ch-stjoseph-stluc-lyon.fr   
Hospices Civils de Lyon, Hôpital E Herriot, Service d'hépatogastroentérologie, 5 place d'Arsonval Recruiting
Lyon, France, 69437
Contact: Christine CHAMBON-AUGOYARD, MD    (0)472 110 130 ext +33    christine.chabom-augoyard@chu-lyon.fr   
Contact: Laurent MAGAUD, Clinical project manager    (0)472 112 805 ext +33    laurent.magaud@chu-lyon.fr   
Hospices Civils de Lyon, Hôpital Lyon Sud, Service d'hépato-gastroentérologie, Chemin Grand Revoyet Recruiting
Pierre Benite, France, 69310
Contact: Marion CHAUVENET, MD       marion.chauvenet@chu-lyon.fr   
Centre Hospitalier Villefranche sur Saône, Service d'Hépato-gastroentérologie, Plateux d'Ouilly Gleize Not yet recruiting
Villefranche Sur Saone, France, 69655
Contact: Fabien PETIT-LAURENT, MD       fpetitlaurent@lhopitalnordouest.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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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
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02861885    
Other Study ID Numbers: 69HCL16_0158
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020
Keywords provided by Hospices Civils de Lyon:
Colonoscopy
sessile serrated lesions
chromoendoscopy
narrow band imaging
Indigo Carmin®
Pit pattern
Kudo classification
NICE classification
neoplasms by histologic type
Additional relevant MeSH terms:
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Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases