Colonic Neoplasms Clinical Trial
Official title:
Endoscopic Surveillance in Patients With Serrated Polyposis Syndrome and Low-risk of Advanced Neoplasia.
Verified date | September 2021 |
Source | Hospital Universitario de Móstoles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the study is to determine if Serrated Poliposis Syndrome (SPS) patients with SPS criteria 2, with clearing phase achieved and without any advanced lesion or less than 5 relevant lesions at last colonoscopy have the same advanced neoplasia incidence in the surveillance colonoscopy at 2 or 3 years. Patients selected for the study will be randomised in two groups for the surveillance: group 1, surveillance with colonoscopy in two years; group 2, surveillance with colonoscopy in three years. Randomization will be done at the database program (RedCAP). All colonoscopies will be performed with high definition (HD) system and it will be the choice of the endoscopist whether to use chromoendoscopy with indigo carmine o virtual chromoendoscopy. Protocol bowel preparation will be recommended by each centre. Sedation will be prescribed and decided by the endoscopist during the examination. Data from all the resected and visualized lesions during the colonoscopy will be collected on the database. A pathologist familiarized with serrated lesions will be in charge of the sample analysis. Serrated lesions will be classified attending de WHO criteria for serrated lesions. The investigators define "advanced adenoma" as adenomas ≥10 mm with villous histology and/or with high grade of dysplasia (HGD). The investigators define "advanced SL" as any SL ≥10mm and any SL with dysplasia. The investigators also define "advanced neoplasia" as any colorectal cancer (CRC), any advanced adenoma or advanced Serrated Lesions (SL). Quality of bowel cleansing will be graded by each endoscopist following the Boston Bowel Preparation Scale. This scale evaluates each segment (ascending colon, transverse colon and descending colon) of the following form: 0 = segment of colon whose mucosa cannot be seen due to the existence of solid stools that cannot be eliminated; 1 = mucosa portion of a colonic segment that can be seen, but other areas of the colonic segment are not seen, either due to the presence of dirt, feces or opaque liquid; 2 = existence of small amount of dirt, small fragments of stool and / or opaque liquid, but the mucosa of the colonic segment can be seen well; 3 = all the mucosa of the colonic segment can be seen well without residual dirt, small traces of stool or opaque liquid. Patients with inadequate preparation (when in any segment the score is 0 or 1, or the total score is less than 6) will be excluded from the study. During colonoscopy all complications as post-polypectomy bleeding, perforation or cardio-respiratory events will be registered. Those complications will be considered if surgery or hospital admission is required.
Status | Recruiting |
Enrollment | 136 |
Est. completion date | November 2023 |
Est. primary completion date | May 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Patients aged 18 years or older that fulfil only WHO criteria 2 of SPS and did not fulfil WHO criteria 1. - Criteria 1: any patient with = 5 SL proximal to the rectum, all =5 mm in size, with at least 2 =10 mm in size. - Criteria 2: any patient with >20 SL of any size distributed throughout the colon, with =5 lesions proximal to the rectum. - Patients with a previous complete colonoscopy with adequate bowel preparation and with all lesions >5mm been resected ("clearance colonoscopy), after the diagnostic of SPS. - Nor advanced adenoma or serrated lesions at prior colonoscopy, and also either more than 5 relevant lesion (adenoma, SSL or PH>5mm) at prior colonoscopy. Exclusion Criteria: - Patients with no inform consent or who do not agree to participate in the study. - Patients with total or partial colectomy. - Patients with other CCR predisposing syndromes with germinal mutation (Familial adenomatous polyposis, Lynch syndrome, Peutz-Jehgers syndrome, Cowden syndrome, Juvenile polyposis syndrome…). - Patients with chronic inflammatory bowel disease. - Patients with coagulation disorders. - Fragmented lesion or submucosal invasive lesion at last colonoscopy. - Inadequate colon preparation: any segment of the colon with <2 points in Boston Scale (BBPS). |
Country | Name | City | State |
---|---|---|---|
Spain | Jorge López Vicente | Móstoles | Madrid |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitario de Móstoles |
Spain,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Advanced neoplasia and colorectal cancer incidence at 2 years | Number of CCR and advanced neoplasia detected in SPS patients with low risk factors of advanced neoplasia during surveillance after a 2 year colonoscopy. | 2 years | |
Primary | Advanced neoplasia and colorectal cancer incidence at 3 years | Number of CCR and advanced neoplasia detected in SPS patients with low risk factors of advanced neoplasia during surveillance after a 3 year colonoscopy. | 3 years |
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