Clinical trial NCT04232176: Precision of Optical Diagnosis in Polyps Between 5-15 mm and Its Implications on Surveillance. A Prospective, Multicenter Study.
Official title: Precision of Optical Diagnosis in Polyps Between 5-15 mm and Its Implications on Surveillance. A Prospective, Multicenter Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonic Polyps
Colon Neoplasms
Colon Cancer
Serrated Adenoma
Keywords: Endoscopic optical diagnosis
Lead sponsor: University Hospital Virgen de las Nieves
Sponsor class: OTHER
Collaborators: name: Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
First posted: 2020-01-18
Enrollment: 545
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that come to the endoscopy unit for colorectal cancer screening or with a specific clinical indication during the study period, in any of the participating hospitals.

Brief summary: This study evaluates the ability of endoscopists to perform a complete optical diagnosis of colorectal polyps between 5 and 15 mm, and the impact of the only endoscopic diagnosis on the follow-up program for those patients. This is a prospective study in which we compare the diagnosis regarding size and histology made by the endoscopist versus de pathologic diagnosis.

Detailed description: Background: Optical diagnosis of colonic polyps is an attractive possibility and a common practice. However, recommendations and the main decision concerning patients' management still rely on histological diagnosis, with controversial results in previous studies, usually designed to analyze the accuracy of this diagnosis in the setting of a 'resect and discard' or 'diagnose and leave' strategy. However, little has been studied on this diagnosis on polyps of about 10 mm, the threshold for the consideration as a high risk adenoma, that need a 3 year colonoscopy, or, in case of a smaller adenoma, with a recommended revision in 5 years. Some studies have addressed the accuracy when estimating the polyp size, and others the histology by means of virtual or optical chromoendoscopy, but no one has studied both parameters, that are the two pillars in which a revision program for the patient is decided.

Hypothesis: Our main purpose is to determine the accuracy of the complete optical diagnosis as made by the endoscopist in the endoscopy room, in order to give recommendations immediately after the colonoscopy, with no need of further histological analyses.

Aims:

* To establish endoscopist accuracy, in different hospital settings, to predict size and histology of polyps between 5 and 15 mm and whether follow-up recommedations based on this diagnosis are accurate enough, when compared to the pathologic diagnosis.
* To evaluate accuracy of the optical size estimation by the endoscopist, with respect to the measurement after resection and by the pathologist (after formaline fixation).
* To analyze the rate of sessile serrated adenoma not diagnosed by the endoscopista on site.
* To determine the proportion of incomplete resection and complications with different resection techniques.
* To follow-up patients with high risk adenoma with the aim to establish the best follow-up schedule for those patients, and clarify this topic, still subjected to uncertainty.

Eligibility criteria: Inclusion Criteria:

* Age between 18-80 years
* Colorectal polyps with an estimated size (endoscopist estimation) between 5 and 15 mm.
* Consent to be included in the protocol.

Exclusion Criteria:

* Polyps sized \<5 mm or \>15 mm
* Polyps that cannot be resected.
* Polys that cannot be sent for pathologic study.
* Peacemeal resection.
* Polyposis syndromes with a previous histologic diagnosis.
* Patients do not consent to participate in the study.

Primary outcomes:
measure: Concordance of optical diagnosis with pathologic diagnosis
timeFrame: Immediate after the polyps detection
measure: Precision in polyps sizing the pathologist
timeFrame: Immediate after resection and within 10 days after polyp resection to allow pathologic diagnosis
Secondary outcomes:
measure: Rate of polyps' recurrence at the end of the follow-up.
timeFrame: 5 years after the index resection
Other outcomes:
Locations:
city: Granada
country: Spain
facility: "Virgen de las Nieves" University Hospital
Study officials:
affiliation: 'Virgen de las Nieves' University Hospital. Granada
name: Clara Heredia-Carrasco, MD
role: PRINCIPAL_INVESTIGATOR
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