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CompletedNCT02196649CuRBUpdated Mar 27, 2025

Clip Placement Following Endoscopic Mucosal Resection - Randomised Trial

An interventional study of Endoscopic Clip in Colonic Polyps, sponsored by Professor Michael Bourke. Completed at 1 site in Australia. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-03-27.

Sponsored by Professor Michael Bourke · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
230
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
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Study summary

Patients will be randomised to have endoscopic clips applied to the Endoscopic Mucosal Resection (EMR) site following complete removal of the lesion, or will not receive clips and proceed with standard of care.

Read the detailed description

The outlined literature suggests that colonic post EMR bleeding may be prevented by the use of prophylactic endoscopic clips. There has thus far been no prospective study to confirm this concept. The ideal way to prove the hypothesis is to conduct a randomised controlled trial to evaluated the use of prophylactic clip placement on the EMR resection defect, for the purpose of preventing delayed bleeding in colonic wide field EMR (lesions>20mm). Given the significantly increased rate of bleeding in the proximal colon, clip placement in this location may have the greatest benefit. If it is proven that such a prophylactic technique is effective and safe, it may lead to significantly decreased patient morbidity and health care resources associated with the management delayed bleeding.

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Conditions studied

  • Colonic Polyps

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03

In context

Colonic Polyps

318 studies on the registry are indexed under Colonic Polyps; 54 are open to participants now.

This study's enrollment of 230 is below the median of 270 across 215 interventional studies indexed under Colonic Polyps.

Browse Colonic Polyps studies →

Lead sponsor

Professor Michael Bourke is the lead sponsor of 20 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Can give informed consent to trial participation
  • Lesion size greater than 20 mm
  • Lesion proximal to and inclusive of mid transverse colon
  • Laterally spreading or sessile polyp morphology

Exclusion criteria

Exclusion Criteria:

  • Previous resection or attempted resection of lesion
  • Clip deployed prior to the completion of the EMR
  • Major intraprocedural bleeding not treatable by coagulation
  • Endoscopic appearance of invasive malignancy
  • Age less than 18 years
  • Pregnancy
  • Active Inflammatory colonic conditions (e.g. inflammatory bowel disease)
  • Use of anticoagulant or antiplatelet agents other than aspirin less than 5 days prior to procedure
  • American Society of Anesthesiology (ASA) Grade IV-V
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
230 participants (actual)

Study arms

  • Experimental
    Endoscopic Clipping

    Participants randomised to the arm will receive endoscopic clips to their defect following EMR.

    Device: Endoscopic Clip

  • No intervention
    No Endoscopic Clipping

    These participants will receive standard of care practice only.

Interventions

  • DeviceEndoscopic Clip
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What researchers measure

Primary outcomes

  1. Post-Procedural Bleeding

    Clinically significant post colonic wide-field EMR bleeding (CSPEB)

    Time frame: 14 days

Secondary outcomes

  1. Safety success

    Safety - admission rates, adverse outcomes, deaths Rate of initial technical success Duration of procedure Recurrence rate

    Time frame: 18 months

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Study locations

1 site
  • Westmead Endoscopy Unit
    Westmead, New South Wales 2145, Australia
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References and documents

Publications

  • Gupta S, Sidhu M, Shahidi N, Vosko S, McKay O, Bahin FF, Zahid S, Whitfield A, Byth K, Brown G, Lee EYT, Williams SJ, Burgess NG, Bourke MJ. Effect of prophylactic endoscopic clip placement on clinically significant post-endoscopic mucosal resection bleeding in the right colon: a single-centre, randomised controlled trial. Lancet Gastroenterol Hepatol. 2022 Feb;7(2):152-160. doi: 10.1016/S2468-1253(21)00384-8. Epub 2021 Nov 18. PubMed 34801133 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02196649
Lead sponsor
Professor Michael Bourke
Responsible party
Professor Michael Bourke (Director of Gastrointestinal Endoscopy, Western Sydney Local Health District) — Sponsor-investigator
First posted
Jul 22, 2014
Start date
Oct 2014
Primary completion
Dec 1, 2020
Completion
Mar 1, 2021
Last update
Mar 27, 2025

Study contacts

Michael J Bourke, MBBS
principal investigator · Western Sydney Local Health District

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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