POPS: Precision of Optical Diagnosis in Polyps Between 5-15 mm and Its Implications on Surveillance. A Prospective, Multicenter Study.

Sponsor

University Hospital Virgen de las Nieves (Other)

Overall Status

Completed

CT.gov ID

NCT04232176

Collaborator

Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental (Other)

545

Enrollment

Location

25.3

Actual Duration (Months)

21.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colonic Polyps Colon Neoplasms Colon Cancer Serrated Adenoma

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.

Study Design

Study Type:

Observational

Actual Enrollment :

545 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Precision of Optical Diagnosis in Polyps Between 5-15 mm and Its Implications on Surveillance. A Prospective, Multicenter Study.

Actual Study Start Date :

Dec 22, 2019

Actual Primary Completion Date :

Dec 1, 2021

Actual Study Completion Date :

Jan 31, 2022

Outcome Measures

Primary Outcome Measures

Concordance of optical diagnosis with pathologic diagnosis [Immediate after the polyps detection]
Optical diagnosis accuracy (endoscopist) when compared to the Pathologic report
Precision in polyps sizing the pathologist [Immediate after resection and within 10 days after polyp resection to allow pathologic diagnosis]
Comparison of sizes after resection and after formaline and pathologic diagnosis

Secondary Outcome Measures

Rate of polyps' recurrence at the end of the follow-up. [5 years after the index resection]
Polyps recurrence after long-term follow up for advanced adenoma (Rate)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	"Virgen de las Nieves" University Hospital	Granada		Spain	18014

Sponsors and Collaborators

University Hospital Virgen de las Nieves
Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental

Investigators

Principal Investigator: Clara Heredia-Carrasco, MD, 'Virgen de las Nieves' University Hospital. Granada

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

EDUARDO REDONDO CEREZO, MD, PhD, Head of Gastroenterology, University Hospital Virgen de las Nieves

ClinicalTrials.gov Identifier:

NCT04232176

Other Study ID Numbers:

POPS.HUVN.19

First Posted:

Jan 18, 2020

Last Update Posted:

May 17, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by EDUARDO REDONDO CEREZO, MD, PhD, Head of Gastroenterology, University Hospital Virgen de las Nieves

Endoscopic optical diagnosis

Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2022