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DN-PEC: Dutch National Prospective EMR Cohort

Sponsor
Radboud University Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03545061
Collaborator
(none)
2,000
Enrollment
1
Location
82.8
Anticipated Duration (Months)
24.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A Prospective Study: Longterm Follow Up until S2 (2nd surveillance) at 18 months after EMR for Large Flat/Sessile Colonic Polyps.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Dutch National Prospective EMR Cohort. Longterm Follow Up After EMR for Large Flat/Sessile Colonic Polyps, a Prospective Study.
    Actual Study Start Date :
    Aug 6, 2018
    Anticipated Primary Completion Date :
    Jul 1, 2022
    Anticipated Study Completion Date :
    Jul 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Complications [30 days post EMR]

      Delayed bleeding, perforation and postpolypectomy syndrome

    2. Recurrence [6 months (S1) and 18 months (S2) after EMR]

      Pathological and endoscopical re-appearance of adenoma

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Flat or sessile polyp morphology (Paris classification 0-IIa/b/c, Is)

    • Polyp size >20 mm

    • Therapy: EMR

    • Age > 18 years old

    • Written informed consent

    Exclusion Criteria:
    • Participation in a competing study, such as the "CLIPPER trial" (registration number: NL62949.091.17).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Radboudumc Nijmegen Gelderland Netherlands 6525GA

    Sponsors and Collaborators

    • Radboud University Medical Center

    Investigators

    • Principal Investigator: E. Van Geenen, dr, Radboud University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Radboud University Medical Center
    ClinicalTrials.gov Identifier:
    NCT03545061
    Other Study ID Numbers:
    • 2018-4449
    First Posted:
    Jun 4, 2018
    Last Update Posted:
    Oct 9, 2020
    Last Verified:
    Oct 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Polyps

    Study Results

    No Results Posted as of Oct 9, 2020