Precision of Optical Diagnosis in Polyps Between 5-15 mm and Its Implications on Surveillance. A Prospective, Multicenter Study.
Condition: Colonic Polyps; Colon Neoplasms; Colon Cancer; Serrated Adenoma
MeSH terms: Colonic Neoplasms; Adenoma; Polyps; Colonic Polyps
Study type: Observational

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.
    

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.
      
Keywords: Endoscopic optical diagnosis