NCT02711475

Brief Summary

Diminutive polyps, measuring between 1 and 5 mm, represent the vast majority of colorectal polyps encountered during colonoscopy. Since the chance of harboring advanced adenoma or carcinoma in this kind of polyps is very low, a "remove and discard" technique has been proposed. The differentiation between adenoma/non adenoma polyps is based on the use of endoscopes equipped with high definition, magnification and optical filters.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

January 10, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

November 8, 2017

Status Verified

November 1, 2017

Enrollment Period

12 months

First QC Date

March 8, 2016

Last Update Submit

November 7, 2017

Conditions

Colonic Polyps

Outcome Measures

Primary Outcomes (1)

  • Percentage of accordance between endoscopic and histologic assignment of the polyps to the adenoma/non adenoma category

    All the retrieved polyps will be examined and the percentage of accordance between the endoscopic and histologic diagnosis will be determined

    1 year

Secondary Outcomes (2)

  • Cost savings expressed in dollars between the "remove and discard" technique and histologic examination of samples

    1 year

  • Percentage of concordance between the surveillance periods, determined on the basis of the endoscopic and histologic evaluation of the polyps

    1 year

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All pationts undergoing screening and non screening colonoscopy

You may qualify if:

  • All subjects undergoing colonoscopy

You may not qualify if:

  • Patients assuming oral anticoagulant therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardinal Massaia Hospital

Asti, AT, 14100, Italy

RECRUITING

Related Publications (6)

  • Murino A, Hassan C, Repici A. The diminutive colon polyp: biopsy, snare, leave alone? Curr Opin Gastroenterol. 2016 Jan;32(1):38-43. doi: 10.1097/MOG.0000000000000230.

    PMID: 26574868BACKGROUND

  • Repici A, Hassan C, Radaelli F, Occhipinti P, De Angelis C, Romeo F, Paggi S, Saettone S, Cisaro F, Spaander M, Sharma P, Kuipers EJ. Accuracy of narrow-band imaging in predicting colonoscopy surveillance intervals and histology of distal diminutive polyps: results from a multicenter, prospective trial. Gastrointest Endosc. 2013 Jul;78(1):106-14. doi: 10.1016/j.gie.2013.01.035. Epub 2013 Apr 11.

    PMID: 23582472BACKGROUND

  • Radaelli F. The Resect-and-Discard Strategy for Management of Small and Diminutive Colonic Polyps. Gastroenterol Hepatol (N Y). 2013 May;9(5):305-8. No abstract available.

    PMID: 23943666BACKGROUND

  • Paggi S, Radaelli F, Repici A, Hassan C. Advances in the removal of diminutive colorectal polyps. Expert Rev Gastroenterol Hepatol. 2015 Feb;9(2):237-44. doi: 10.1586/17474124.2014.950955. Epub 2014 Aug 26.

    PMID: 25155348BACKGROUND

  • ASGE Technology Committee; Abu Dayyeh BK, Thosani N, Konda V, Wallace MB, Rex DK, Chauhan SS, Hwang JH, Komanduri S, Manfredi M, Maple JT, Murad FM, Siddiqui UD, Banerjee S. ASGE Technology Committee systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting real-time endoscopic assessment of the histology of diminutive colorectal polyps. Gastrointest Endosc. 2015 Mar;81(3):502.e1-502.e16. doi: 10.1016/j.gie.2014.12.022. Epub 2015 Jan 16.

    PMID: 25597420BACKGROUND

  • Rameshshanker R, Wilson A. Electronic Imaging in Colonoscopy: Clinical Applications and Future Prospects. Curr Treat Options Gastroenterol. 2016 Mar;14(1):140-51. doi: 10.1007/s11938-016-0075-1.

    PMID: 26923476RESULT

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • CARLO VERNA, M.D.

    CARDINAL MASSAIA HOSPITAL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

CARLO VERNA, M.D.

CONTACT

+3914148karleorn@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

March 8, 2016

First Posted

March 17, 2016

Study Start

January 10, 2017

Primary Completion

December 31, 2017

Study Completion

January 1, 2018

Last Updated

November 8, 2017

Record last verified: 2017-11

Locations

IT(1)