Status:
COMPLETED
Accuracy for Predicting Deep Submucosal Invasion
Lead Sponsor:
Althaia Xarxa Assistencial Universitària de Manresa
Collaborating Sponsors:
Hospital Universitario La Fe
Hospital Clínico Universitario Lozano Blesa
Conditions:
Colorectal Cancer
Colorectal Polyp
Eligibility:
All Genders
18+ years
Brief Summary
The main aim of this study is to determine whether the assessment of the invasive pattern based on NBI with dual focus/magnification or BLI with magnification ± chromoendoscopy (NBI+CE) for predicting...
Detailed Description
A video with the lesion assessment, without any data on the patient, will be recorded in a device connected to the processor provided by the Principal Investigator. The name of the file will be the re...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Non-pedunculated type 0 lesions in Paris classification (not obvious cancers)
- Lesions larger than 10 mm
- Exclusion criteria are:
- Lesions assessed as JNET 1 by the endoscopist or serrated by the pathologist
- Previous biopsy or resection attempt
- Previous CT, MR or USE
- Unavailable histology
- Inflammatory bowel disease
- Informed consent not obtained
- Protocol violation
Exclusion
Key Trial Info
Start Date :
December 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 30 2022
Estimated Enrollment :
426 Patients enrolled
Trial Details
Trial ID
NCT03748667
Start Date
December 1 2018
End Date
October 30 2022
Last Update
September 21 2023
Active Locations (14)
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1
San Francisco Veterans Affairs Medical Center. University of California
San Francisco, California, United States, 94121
2
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
3
National Cancer Center
Tokyo, Japan, 104-0045
4
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Aragon, Spain, 50009