Status:
COMPLETED
Endoscopic Surveillance in Serrated Polyposis Syndrome and Low-risk of Advanced Neoplasia
Lead Sponsor:
Hospital Universitario de Móstoles
Conditions:
Colonic Polyp
Colonic Neoplasms
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The aim of the study is to determine if Serrated Poliposis Syndrome (SPS) patients with SPS criteria, with clearing phase achieved and without any advanced lesion or less than 5 relevant lesions at la...
Detailed Description
Colorectal cancer (CRC) is the most frequent neoplasm in developed countries considering both sexes and is the second in terms of cancer mortality. The incidence of the CRC is increasing in all develo...
Eligibility Criteria
Inclusion
- Patients aged 18 years or older that fulfil WHO criteria 1 or 2 of SPS:
- 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
- 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).
Key Trial Info
Start Date :
June 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2024
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT04906343
Start Date
June 5 2021
End Date
November 22 2024
Last Update
February 18 2025
Active Locations (1)
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1
Jorge López Vicente
Móstoles, Madrid, Spain, 282935