Colorectal NeoplasmLesion SSLNCT02861885
Detection and Characterization of Sessile Serrated Lesions (SSL) of the Right Colon
An observational study of Colorectal Neoplasm and Sessile Serrated Lesion, run by Hospices Civils de Lyon at 6 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasm, Sessile Serrated Lesion, Neoplasms
- What is being tested?
- Chromoendoscopy
- How many people
- 71 participants
- Where
- 6 sitesFrance
- Study dates
- 24 Feb 2016to 24 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population being studied is the cohort of patients referred for a colonoscopy resulting screening indication, digestive syndrome or monitoring.
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- History of digestive resection as resection of the right colon (right ileocolectomy, right hemicolectomy) or large colic resection.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Hôpital Estaing, CHU Clermont Ferrand, NHE Service d'Hépato-gastroentérologie, 1 place Lucie Aubrac
Clermont-Ferrand, 63003
Centre Hospitalier Saint JOSEPH Saint Luc, Service d'hépato-gastroentérologie, 20 quai Claude Bernard
Lyon, 69004
Hospices Civils de Lyon, Hôpital de la Croix Rousse, Service d'hépato-gastroentérologie, 103 Grande-Rue de la Croix Rousse
Lyon, 69317
Hospices Civils de Lyon, Hôpital E Herriot, Service d'hépatogastroentérologie, 5 place d'Arsonval
Lyon, 69437
Hospices Civils de Lyon, Hôpital Lyon Sud, Service d'hépato-gastroentérologie, Chemin Grand Revoyet
Pierre-Bénite, 69310
Centre Hospitalier Villefranche sur Saône, Service d'Hépato-gastroentérologie, Plateux d'Ouilly Gleize
Villefranche-sur-Saône, 69655
About this study
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.
Read more
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
- Being tested
- Chromoendoscopy
- Keywords
- Colonoscopy, sessile serrated lesions, chromoendoscopy, narrow band imaging, Indigo Carmin®, Pit pattern, Kudo classification, NICE classification, neoplasms by histologic type
- Medical subject headings
- Colorectal Neoplasms, Neoplasms, Neoplasms by Histologic Type
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChromoendoscopyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Lesion SSL | Patient cohort referred by colonoscopy screening indication, digestive syndrome or monitoring, with ascendant colon macroscopic SSL suspicion throughout white light during colonoscopy Receives: Other: Chromoendoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at colonoscopy day (Day 1)
Secondary outcomes (13)
PARIS classification
All SSL will be characterized using the PARIS classification of colorectal polyps
Measured: at colonoscopy day (Day 1)
Kudo's pit pattern classification
All SSL will be characterized using the Kudo's pit pattern classification for colorectal neoplasms
Measured: at colonoscopy day (Day 1)
NICE classification
All SSL will be characterized using the Narrow band imaging International Colorectal Endoscopic (NICE) of small colorectal polyps.
Measured: at colonoscopy day (Day 1)
Specific mean of macroscopically detected SSL
Comparison of the mean number of SSL per technique (white light, Narrow Band Imaging, indigo carmine chromoendoscopy)
Measured: at colonoscopy day (Day 1)
SSL histologic characterization
All SSL will be characterized using the Vienna classification of gastrointestinal epithelial neoplasia
Measured: histopathological results (up to 2 weeks)
False positive
Number of suspected SSL macroscopically but unconfirmed histologically
Measured: histopathological results (up to 2 weeks)
False negative
Number of polyps not identified as SSL, but reclassified by histological results
Measured: histopathological results (up to 2 weeks)
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)
Measured: at colonoscopy day (Day 1)
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)
Measured: at colonoscopy day (Day 1)
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)
Measured: at colonoscopy day (Day 1)
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)
Measured: at colonoscopy day (Day 1)
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)
Measured: at colonoscopy day (Day 1)
Detection techniques diagnosis performance
Proportion of macroscopically suspected SSL by the endoscopist and confirmed as SSL with histological results from expert center (false negative)
Measured: at colonoscopy day (Day 1) + histopathological results (up to 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study start24 Feb 2016
- Primary completion24 Apr 2022 (estimated)
- Study completion24 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine CHAMBON-AUGOYARD, MD, Principal investigator, Hospices Civils de Lyon, Hôpital E Herriot, Service d'hépatogastroentérologie, 5 place d'Arsonval, 69437 LYON cedex 03, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861885
- Sponsor's protocol ID
- 69HCL16_0158
- Acronym
- Lesion SSL
- Status last verified
- Mar 2022
- First submitted
- 2 Aug 2016
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Characterization of Sessile Serrated Lesions (SSL) of the Right Colon
- ClinicalTrials.gov ID
- NCT02861885
- Acronym / sponsor ID
- Lesion SSL / 69HCL16_0158
- Conditions
- Colorectal Neoplasm, Sessile Serrated Lesion, Neoplasms
- Keywords
- Colonoscopy, sessile serrated lesions, chromoendoscopy, narrow band imaging, Indigo Carmin®, Pit pattern, Kudo classification, NICE classification
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 24 Feb 2016 (actual)
- Primary completion
- 24 Apr 2022 (estimated)
- Study completion
- 24 Apr 2022 (estimated)
- First posted
- 10 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lesion SSL | – | Other: ChromoendoscopyPatient cohort referred by colonoscopy screening indication, digestive syndrome or monitoring, with ascendant colon macroscopic SSL suspicion throughout white light during colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population being studied is the cohort of patients referred for a colonoscopy resulting screening indication, digestive syndrome or monitoring.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (1 listed)
- History of digestive resection as resection of the right colon (right ileocolectomy, right hemicolectomy) or large colic resection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChromoendoscopyColonoscopy 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. | Other | Lesion SSL |
Primary outcome
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
13 secondary outcomes
PARIS classification
Time frame: at colonoscopy day (Day 1)
Kudo's pit pattern classification
Time frame: at colonoscopy day (Day 1)
NICE classification
Time frame: at colonoscopy day (Day 1)
Specific mean of macroscopically detected SSL
Time frame: at colonoscopy day (Day 1)
SSL histologic characterization
Time frame: histopathological results (up to 2 weeks)
False positive
Time frame: histopathological results (up to 2 weeks)
False negative
Time frame: histopathological results (up to 2 weeks)
Detection techniques diagnosis performance
Time frame: at colonoscopy day (Day 1)
Detection techniques diagnosis performance
Time frame: at colonoscopy day (Day 1)
Detection techniques diagnosis performance
Time frame: at colonoscopy day (Day 1)
Detection techniques diagnosis performance
Time frame: at colonoscopy day (Day 1)
Detection techniques diagnosis performance
Time frame: at colonoscopy day (Day 1)
Detection techniques diagnosis performance
Time frame: at colonoscopy day (Day 1) + histopathological results (up to 2 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine CHAMBON-AUGOYARD, MD principal investigator
Hospices Civils de Lyon, Hôpital E Herriot, Service d'hépatogastroentérologie, 5 place d'Arsonval, 69437 LYON cedex 03, France
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasm and Sessile Serrated Lesion, run by Hospices Civils de Lyon at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patients with sessile serrated lesions (time frame: at colonoscopy day (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.