Ayla S Turan1, Leon M G Moons2, Ramon-Michel Schreuder3, Erik J Schoon3, Jochim S Terhaar Sive Droste4, Ruud W M Schrauwen5, Jan Willem Straathof6, Barbara A J Bastiaansen7, Matthijs P Schwartz8, Wouter L Hazen9, Alaa Alkhalaf10, Daud Allajar11, Muhammed Hadithi12, Bas W van der Spek13, Dimitri G D N Heine13, Adriaan C I T L Tan14, Wilmar de Graaf15, Jurjen J Boonstra16, Fia J Voogd17, Robert Roomer18, Rogier J J de Ridder19, Wietske Kievit20, Peter D Siersema21, Paul Didden2, Erwin J M van Geenen21. 1. Department of Gastroenterology and Hepatology, Radboud University Medical Center, Radboud Institute of Health Sciences, Nijmegen, Netherlands. ayla.turan@radboudumc.nl. 2. Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, Netherlands. 3. Department of Gastroenterology and Hepatology, Catharina Hospital, Eindhoven, Netherlands. 4. Department of Gastroenterology and Hepatology, Jeroen Bosch Hospital, s' Hertogenbosch, Netherlands. 5. Department of Gastroenterology and Hepatology, Bernhoven, Uden, Netherlands. 6. Department of Gastroenterology and Hepatology, Màxima Medical Center, Veldhoven, Netherlands. 7. Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, location Academic Medical Center, Amsterdam, Netherlands. 8. Department of Gastroenterology and Hepatology, Meander Medical Center, Amersfoort, Netherlands. 9. Department of Gastroenterology and Hepatology, Elisabeth-Tweesteden Hospital, Tilburg, Netherlands. 10. Department of Gastroenterology and Hepatology, Isala Clinics, Zwolle, Netherlands. 11. Department of Gastroenterology and Hepatology, Hospital St. Jansdal, Harderwijk, Netherlands. 12. Department of Gastroenterology and Hepatology, Maasstad Hospital, Rotterdam, Netherlands. 13. Department of Gastroenterology and Hepatology, Noordwest Hospital Group, Alkmaar, Netherlands. 14. Department of Gastroenterology and Hepatology, Canisius-Wilhelmina hospital, Nijmegen, Netherlands. 15. Department of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, Netherlands. 16. Department of Gastroenterology and Hepatology, Leids University Medical Center, Leiden, Netherlands. 17. Department of Gastroenterology and Hepatology, Medical Center Leeuwarden, Leeuwarden, Netherlands. 18. Department of Gastroenterology and Hepatology, Franciscus Gasthuis, Rotterdam, Netherlands. 19. Department of Gastroenterology and Hepatology, Maastricht University Medical Center+, Maastricht, Netherlands. 20. IQ Healthcare, Radboud University Medical Center, Nijmegen, Netherlands. 21. Department of Gastroenterology and Hepatology, Radboud University Medical Center, Radboud Institute of Health Sciences, Nijmegen, Netherlands.
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.
RCT Entities:
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.
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