Dutch National Prospective EMR Cohort (DN-PEC)

October 8, 2020 updated by: Radboud University Medical Center

Dutch National Prospective EMR Cohort. Longterm Follow Up After EMR for Large Flat/Sessile Colonic Polyps, a Prospective Study.

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population is patients with 1 or more large flat or sessile polyps of 2 cm or larger, located in the colon, that are removed with EMR. These will often be patients diagnosed in the scope of the National Colon Cancer Screening programme.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 30 days post EMR
Delayed bleeding, perforation and postpolypectomy syndrome
30 days post EMR
Recurrence
Time Frame: 6 months (S1) and 18 months (S2) after EMR
Pathological and endoscopical re-appearance of adenoma
6 months (S1) and 18 months (S2) after EMR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2018

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

July 1, 2025

Study Registration Dates

First Submitted

May 22, 2018

First Submitted That Met QC Criteria

May 22, 2018

First Posted (Actual)

June 4, 2018

Study Record Updates

Last Update Posted (Actual)

October 9, 2020

Last Update Submitted That Met QC Criteria

October 8, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-4449

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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