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Clip Placement Following Colonic Endoscopic Mucosal Resection (EMR) (CLIPPER)

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ClinicalTrials.gov Identifier: NCT03309683
Recruitment Status : Recruiting
First Posted : October 13, 2017
Last Update Posted : April 20, 2018
Sponsor:
Collaborators:
UMC Utrecht
Maastricht University Medical Center
Erasmus Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Maxima Medical Center
Jeroen Bosch Ziekenhuis
Bernhoven Hospital
Isala
Canisius-Wilhelmina Hospital
Rijnstate Hospital
Noordwest Ziekenhuisgroep
Meander Medisch Centrum
Catharina Ziekenhuis Eindhoven
Elisabeth-TweeSteden Ziekenhuis
Dutch Digestive Diseases Foundation
Information provided by (Responsible Party):
Radboud University

Brief 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.


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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Clip Placement Following Colonic Endoscopic Mucosal Resection (EMR). The CLIPPER Study: A Nationwide Multi-center Randomized Clinical Trail
Actual Study Start Date : March 5, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other Names:
  • prophylactic clipping
  • hemoclip

No Intervention: Control group
Standard treatment after EMR (as described in the detailed study description above)



Primary Outcome Measures :
  1. Delayed bleeding [ Time Frame: 30 days ]
    Clinical relevant delayed bleeding defined according to the ASGE working party document for adverse events in coloscopy.


Secondary Outcome Measures :
  1. Adenoma recurrence [ Time Frame: 180 days ]
    Recurrence rate will be determined by endoscopy and biopsies.

  2. 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.

  3. EMR scar evaluation [ Time Frame: 180 days ]
    EMR scars will be evaluated by endoscopic photography and biopsies.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • laterally spreading or sessile polyp morphology (Paris classification 0-IIa/b/c) proximal to the splenic flexure, measuring 2-6 cm
  • All patients aged >18 years undergoing an EMR
  • Written informed consent

Exclusion Criteria:

  • Previous resection or attempted resection of a lesion less than 30 days ago or in the same session,
  • Clip deployed prior to the completion of the EMR for a perforation or a major intra-procedural bleeding not treatable by coagulation,
  • Endoscopic appearance of invasive malignancy (non-lifting Kato D, Kudo V pit pattern),
  • Pregnancy,
  • Active inflammatory colonic conditions (e.g. inflammatory bowel disease),
  • Insufficiently corrected anticoagulants AND/OR a clotting disorder (platelet count <50x109/l, INR > 1,5),
  • American Society of Anesthesiology (ASA) Grade IV-V,
  • Macroscopic non-radical resection,
  • >1 lesion in 1 session,
  • Involvement of valvula Bauhin or appendiceal orificium

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309683


Contacts
Contact: Ayla S Turan 024 361 1111 ayla.turan@radboudumc.nl

Locations
Netherlands
Ziekenhuis St Jansdal Recruiting
Harderwijk, Gelderland, Netherlands, 3844DG
Contact: Daud Allajar, dr.         
Contact: Ayla Turan, MSc       ayla.turan@radboudumc.nl   
Radboudumc Recruiting
Nijmegen, Gelderland, Netherlands, 6525GA
Contact: Ayla Turan, MSc    0611368110    ayla.turan@radboudumc.nl   
Sponsors and Collaborators
Radboud University
UMC Utrecht
Maastricht University Medical Center
Erasmus Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Maxima Medical Center
Jeroen Bosch Ziekenhuis
Bernhoven Hospital
Isala
Canisius-Wilhelmina Hospital
Rijnstate Hospital
Noordwest Ziekenhuisgroep
Meander Medisch Centrum
Catharina Ziekenhuis Eindhoven
Elisabeth-TweeSteden Ziekenhuis
Dutch Digestive Diseases Foundation
Investigators
Principal Investigator: Erwin JM Van Geenen, dr Radboud University

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT03309683     History of Changes
Other Study ID Numbers: R0003871
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Colonic Polyps
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical