Dutch National Prospective EMR Cohort

Large Bowel Polyp Clinical Trial

— DN-PEC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03545061
• Other study ID #: 2018-4449
• Status: Recruiting
• Start date: August 6, 2018
• Est. completion date: July 2025

Study information

• Verified date: October 2020
• Source: Radboud University
• Contact: Ayla Turan, MSc
• Phone: +31(0)611368110
• Email: ayla.turan[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: July 2025
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Large Bowel Polyp
• Polyps

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications	Delayed bleeding, perforation and postpolypectomy syndrome	30 days post EMR
Primary	Recurrence	Pathological and endoscopical re-appearance of adenoma	6 months (S1) and 18 months (S2) after EMR