Clip Placement Following Colonic Endoscopic Mucosal Resection (EMR) (CLIPPER)
|ClinicalTrials.gov Identifier: NCT03309683|
Recruitment Status : Not yet recruiting
First Posted : October 13, 2017
Last Update Posted : October 13, 2017
Study design: A national, multi-center, patient- an assessor-blinded, randomized clinical trial.
Study population: Patients undergoing EMR with a moderate to severe risk (right sided colon, ≥2cm) of developing Deylaed 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.
|Condition or disease||Intervention/treatment||Phase|
|Polyp, Colonic Bleeding||Device: Olympus Quick Clip Pro - Single Use Repositionable Clips||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||356 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Clip Placement Following Colonic Endoscopic Mucosal Resection (EMR). The CLIPPER Study: A Nationwide Multi-center Randomized Clinical Trail|
|Estimated Study Start Date :||February 2018|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||July 2020|
Experimental: Clip group
Olympus Quick Clip Pro - Single Use Repositionable Clips will be used for Prophylactic clipping after EMR
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.
No Intervention: Control group
Standard treatment after EMR (as described in the detailed study description above)
- Delayed bleeding [ Time Frame: 30 days ]Clinical relevant delayed bleeding defined according to the ASGE working party document for adverse events in coloscopy.
- Adenoma recurrence [ Time Frame: 180 days ]Recurrence rate will be determined by endoscopy and biopsies.
- Cost-effectiveness [ Time Frame: 180 days ]A cost effectiveness analysis will be done, based on length of hospital stay and professional medical attendance and aided by an estimation of the impact on quality of health by the questionnaires EQ-5D, iMCQ, iPCQ.
- EMR scar evaluation [ Time Frame: 180 days ]EMR scars will be evaluated by endoscopic photography and biopsies.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309683
|Contact: Ayla S Turan||024 361 email@example.com|
|Principal Investigator:||Erwin JM Van Geenen, dr||Radboud University|