Clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (CLIPPER): study protocol for a randomized controlled trial
Trials, vol. 22, pp. 63
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.
Authors 25
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Ayla S. Turan corresponding
Radboud University Nijmegen · Radboud University Medical Center · University Medical Center Utrecht · Radboud Institute for Health Sciences
Affiliation as printed
Department of Gastroenterology and Hepatology, Radboud University Medical Center, Radboud Institute of Health Sciences, Nijmegen, Netherlands. ayla.turan@radboudumc.nl
Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, Netherlands
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Catharina Ziekenhuis · University Medical Center Utrecht
Affiliation as printed
Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, Netherlands
Department of Gastroenterology and Hepatology, Catharina Hospital, Eindhoven, Netherlands
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Affiliation as printed
Department of Gastroenterology and Hepatology, Catharina Hospital, Eindhoven, Netherlands
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Catharina Ziekenhuis · Jeroen Bosch Ziekenhuis
Affiliation as printed
Department of Gastroenterology and Hepatology, Catharina Hospital, Eindhoven, Netherlands
Department of Gastroenterology and Hepatology, Jeroen Bosch Hospital, s' Hertogenbosch, Netherlands
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Ziekenhuis Bernhoven · Jeroen Bosch Ziekenhuis
Affiliation as printed
Department of Gastroenterology and Hepatology, Jeroen Bosch Hospital, s' Hertogenbosch, Netherlands
Department of Gastroenterology and Hepatology, Bernhoven, Uden, Netherlands
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Máxima Medisch Centrum · Ziekenhuis Bernhoven
Affiliation as printed
Department of Gastroenterology and Hepatology, Bernhoven, Uden, Netherlands
Department of Gastroenterology and Hepatology, Màxima Medical Center, Veldhoven, Netherlands
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Amsterdam UMC Location University of Amsterdam · Máxima Medisch Centrum · Amsterdam University Medical Centers
Affiliation as printed
Department of Gastroenterology and Hepatology, Màxima Medical Center, Veldhoven, Netherlands
Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, location Academic Medical Center, Amsterdam, Netherlands
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Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers · Meander Medisch Centrum
Affiliation as printed
Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, location Academic Medical Center, Amsterdam, Netherlands
Department of Gastroenterology and Hepatology, Meander Medical Center, Amersfoort, Netherlands
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Elisabeth-TweeSteden Ziekenhuis · Meander Medisch Centrum
Affiliation as printed
Department of Gastroenterology and Hepatology, Meander Medical Center, Amersfoort, Netherlands
Department of Gastroenterology and Hepatology, Elisabeth-Tweesteden Hospital, Tilburg, Netherlands
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Isala · Elisabeth-TweeSteden Ziekenhuis
Affiliation as printed
Department of Gastroenterology and Hepatology, Elisabeth-Tweesteden Hospital, Tilburg, Netherlands
Department of Gastroenterology and Hepatology, Isala Clinics, Zwolle, Netherlands
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Affiliation as printed
Department of Gastroenterology and Hepatology, Isala Clinics, Zwolle, Netherlands
Department of Gastroenterology and Hepatology, Hospital St. Jansdal, Harderwijk, Netherlands
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Affiliation as printed
Department of Gastroenterology and Hepatology, Hospital St. Jansdal, Harderwijk, Netherlands
Department of Gastroenterology and Hepatology, Maasstad Hospital, Rotterdam, Netherlands
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Noordwest Ziekenhuisgroep · Maasstad Ziekenhuis
Affiliation as printed
Department of Gastroenterology and Hepatology, Maasstad Hospital, Rotterdam, Netherlands
Department of Gastroenterology and Hepatology, Noordwest Hospital Group, Alkmaar, Netherlands
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Affiliation as printed
Department of Gastroenterology and Hepatology, Noordwest Hospital Group, Alkmaar, Netherlands
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Noordwest Ziekenhuisgroep · Canisius-Wilhelmina Ziekenhuis
Affiliation as printed
Department of Gastroenterology and Hepatology, Noordwest Hospital Group, Alkmaar, Netherlands
Department of Gastroenterology and Hepatology, Canisius-Wilhelmina hospital, Nijmegen, Netherlands
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Erasmus MC · Canisius-Wilhelmina Ziekenhuis
Affiliation as printed
Department of Gastroenterology and Hepatology, Canisius-Wilhelmina hospital, Nijmegen, Netherlands
Department of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, Netherlands
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Leiden University Medical Center · Erasmus MC
Affiliation as printed
Department of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, Netherlands
Department of Gastroenterology and Hepatology, Leids University Medical Center, Leiden, Netherlands
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Leiden University Medical Center · Medisch Centrum Leeuwarden
Affiliation as printed
Department of Gastroenterology and Hepatology, Leids University Medical Center, Leiden, Netherlands
Department of Gastroenterology and Hepatology, Medical Center Leeuwarden, Leeuwarden, Netherlands
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Medisch Centrum Leeuwarden · Sint Franciscus Gasthuis
Affiliation as printed
Department of Gastroenterology and Hepatology, Medical Center Leeuwarden, Leeuwarden, Netherlands
Department of Gastroenterology and Hepatology, Franciscus Gasthuis, Rotterdam, Netherlands
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Maastricht University Medical Centre · Maastricht University · Sint Franciscus Gasthuis
Affiliation as printed
Department of Gastroenterology and Hepatology, Franciscus Gasthuis, Rotterdam, Netherlands
Department of Gastroenterology and Hepatology, Maastricht University Medical Center+, Maastricht, Netherlands
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Radboud University Nijmegen · Maastricht University Medical Centre · Radboud University Medical Center · Maastricht University
Affiliation as printed
Department of Gastroenterology and Hepatology, Maastricht University Medical Center+, Maastricht, Netherlands
IQ Healthcare, Radboud University Medical Center, Nijmegen, Netherlands
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Radboud University Nijmegen · Radboud University Medical Center · Radboud Institute for Health Sciences
Affiliation as printed
IQ Healthcare, Radboud University Medical Center, Nijmegen, Netherlands
Department of Gastroenterology and Hepatology, Radboud University Medical Center, Radboud Institute of Health Sciences, Nijmegen, Netherlands
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Radboud University Nijmegen · Radboud University Medical Center · University Medical Center Utrecht · Radboud Institute for Health Sciences
Affiliation as printed
Department of Gastroenterology and Hepatology, Radboud University Medical Center, Radboud Institute of Health Sciences, Nijmegen, Netherlands
Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, Netherlands
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Radboud University Nijmegen · Radboud University Medical Center · University Medical Center Utrecht · Radboud Institute for Health Sciences
Affiliation as printed
Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, Netherlands
Department of Gastroenterology and Hepatology, Radboud University Medical Center, Radboud Institute of Health Sciences, Nijmegen, Netherlands
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Radboud University Nijmegen · Radboud University Medical Center · Radboud Institute for Health Sciences
Affiliation as printed
Department of Gastroenterology and Hepatology, Radboud University Medical Center, Radboud Institute of Health Sciences, Nijmegen, Netherlands
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