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. 2021 Jan 18;22(1):63.
doi: 10.1186/s13063-020-04996-7.

Clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (CLIPPER): study protocol for a randomized controlled trial

Ayla S Turan  1 , Leon M G Moons  2 , Ramon-Michel Schreuder  3 , Erik J Schoon  3 , Jochim S Terhaar Sive Droste  4 , Ruud W M Schrauwen  5 , Jan Willem Straathof  6 , Barbara A J Bastiaansen  7 , Matthijs P Schwartz  8 , Wouter L Hazen  9 , Alaa Alkhalaf  10 , Daud Allajar  11 , Muhammed Hadithi  12 , Bas W van der Spek  13 , Dimitri G D N Heine  13 , Adriaan C I T L Tan  14 , Wilmar de Graaf  15 , Jurjen J Boonstra  16 , Fia J Voogd  17 , Robert Roomer  18 , Rogier J J de Ridder  19 , Wietske Kievit  20 , Peter D Siersema  21 , Paul Didden  2 , Erwin J M van Geenen  21 ; Dutch EMR Study Group
Affiliations

Clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (CLIPPER): study protocol for a randomized controlled trial

Ayla S Turan et al. Trials. .

Abstract

Background: Endoscopic mucosal resection (EMR) for large colorectal polyps is in most cases the preferred treatment to prevent progression to colorectal carcinoma. The most common complication after EMR is delayed bleeding, occurring in 7% overall and in approximately 10% of polyps ≥ 2 cm in the proximal colon. Previous research has suggested that prophylactic clipping of the mucosal defect after EMR may reduce the incidence of delayed bleeding in polyps with a high bleeding risk.

Methods: The CLIPPER trial is a multicenter, parallel-group, single blinded, randomized controlled superiority study. A total of 356 patients undergoing EMR for large (≥ 2 cm) non-pedunculated polyps in the proximal colon will be included and randomized to the clip group or the control group. Prophylactic clipping will be performed in the intervention group to close the resection defect after the EMR with a distance of < 1 cm between the clips. Primary outcome is delayed bleeding within 30 days after EMR. Secondary outcomes are recurrent or residual polyps and clip artifacts during surveillance colonoscopy after 6 months, as well as cost-effectiveness of prophylactic clipping and severity of delayed bleeding.

Discussion: The CLIPPER trial is a pragmatic study performed in the Netherlands and is powered to determine the real-time efficacy and cost-effectiveness of prophylactic clipping after EMR of proximal colon polyps ≥ 2 cm in the Netherlands. This study will also generate new data on the achievability of complete closure and the effects of clip placement on scar surveillance after EMR, in order to further promote the debate on the role of prophylactic clipping in everyday clinical practice.

Trial registration: ClinicalTrials.gov NCT03309683 . Registered on 13 October 2017. Start recruitment: 05 March 2018. Planned completion of recruitment: 31 August 2021.

Keywords: Clip artifact; Colonic polyp; Delayed bleeding; EMR; Prophylactic clipping.

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Conflict of interest statement

This study is performed with material research support (Quick Clip Pro endoclip) from Olympus (Japan). EvG receives research support from MTW (Germany). PS receives research support from Pentax (Japan) and is on the advisory board of Boston Scientific (USA). LM is a consultant for Boston Scientific (USA). All other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Prophylactic clip closure in a zipper fashion. a A mucosal defect after EMR. In b, two clips are placed in a zipper fashion, approximating the defect margins. In c, clipping is complete after six clips have been placed in a zipper fashion
Fig. 2
Fig. 2
EMR defects with prophylactic clip closure. a A mucosal defect after EMR. In b, the EMR defect from A has been approximated with three clips. c Another mucosal defect after EMR. In d, the EMR defect from c has been closed with four clips
See this image and copyright information in PMC

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