Clip Placement Following Colonic Endoscopic Mucosal Resection (EMR)

Summary

Study design: A national, multi-center, patient-blinded, randomized clinical trial.

Study population: Patients undergoing EMR with a moderate to severe risk (right sided colon, ≥2cm) of developing Delayed Bleeding (DB).

Intervention: PC will be compared to standard care (no PC).

Main study endpoints: Primary endpoint is the incidence of DB. Secondary endpoints are cost-effectiveness, quality of life and (severe) adverse events related to PC, adenoma recurrence and risk factors for DB.

Conditions

• Polyp, Colonic
• Bleeding

Interventions

DEVICE

Olympus Quick Clip Pro - Single Use Repositionable Clips

A hemoclip will be placed after every 0,5-1,0 cm of the resected area to proximate wound edges.

Sponsors & Collaborators

• UMC Utrecht

  collaborator OTHER

• Maastricht University Medical Center

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• Maxima Medical Center

  collaborator OTHER

• Jeroen Bosch Ziekenhuis

  collaborator OTHER

• Bernhoven Hospital

  collaborator OTHER

• Isala

  collaborator OTHER

• Canisius-Wilhelmina Hospital

  collaborator OTHER

• Maasstad Hospital

  collaborator OTHER

• Noordwest Ziekenhuisgroep

  collaborator OTHER

• Meander Medisch Centrum

  collaborator OTHER

• Catharina Ziekenhuis Eindhoven

  collaborator OTHER

• Elisabeth-TweeSteden Ziekenhuis

  collaborator OTHER

• St Jansdal Hospital

  collaborator OTHER

• Leiden University Medical Center

  collaborator OTHER

• Dutch Digestive Diseases Foundation

  collaborator OTHER

• Franciscus Gasthuis

  collaborator OTHER

• Bravis Hospital

  collaborator OTHER

• Radboud University Medical Center

  lead OTHER

Principal Investigators

• Erwin JM Van Geenen, dr · Radboud University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-03-05

Primary Completion

2022-08-19

Completion

2023-03-01

Countries

• Netherlands

Study Locations