Clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (CLIPPER): study protocol for a randomized controlled trial
Year: 2021
Type: article
Study design: Study Protocol
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.
Source: Trials
Authors: on behalf of the Dutch EMR Study Group, Ayla S. Turan, Leon M. G. Moons, Ramon-Michel Schreuder, Erik J. Schoon, Jochim S. Terhaar sive Droste, Ruud W. M. Schrauwen, Jan Willem Straathof, Barbara A. J. Bastiaansen, Matthijs P. Schwartz, Wouter L. Hazen, Alaa Alkhalaf, Daud Allajar, Muhammed Hadithi, Bas W. van der Spek, Dimitri G. D. N. Heine, Adriaan C. I. T. L. Tan, Wilmar de Graaf, Jurjen J. Boonstra, Fia J. Voogd, Robert Roomer, Rogier J. J. de Ridder, Wietske Kievit, Peter D. Siersema, Paul Didden, Erwin J. M. van Geenen
Institutions: Radboud University Nijmegen, Radboud University Medical Center, Radboud Institute for Health Sciences, University Medical Center Utrecht, Catharina Ziekenhuis, Jeroen Bosch Ziekenhuis, Ziekenhuis Bernhoven, Máxima Medisch Centrum, Amsterdam UMC Location University of Amsterdam, Amsterdam University Medical Centers, Meander Medisch Centrum, Elisabeth-TweeSteden Ziekenhuis, Isala, Maasstad Ziekenhuis, Noordwest Ziekenhuisgroep, Canisius-Wilhelmina Ziekenhuis, Erasmus MC, Leiden University Medical Center, Medisch Centrum Leeuwarden, Sint Franciscus Gasthuis, Maastricht University Medical Centre, Maastricht University
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,290
Funder: Maag Lever Darm Stichting
Award: G6317107335
OpenAlex ID: W3124461344