Effect of prophylactic endoscopic clip placement on clinically significant post-endoscopic mucosal resection bleeding in the right colon: a single-centre, randomised controlled trial

Department of Gastroenterology and Hepatology, Westmead Hospital, Sydney, NSW, Australia; Westmead Clinical School, University of Sydney, Sydney, NSW, Australia. Department of Gastroenterology and Hepatology, Westmead Hospital, Sydney, NSW, Australia; Westmead Clinical School, University of Sydney, Sydney, NSW, Australia; Department of Medicine, University of British Columbia, Vancouver, Canada. Department of Gastroenterology and Hepatology, Westmead Hospital, Sydney, NSW, Australia. Western Sydney Local Health District Research and Education Network, Westmead Hospital, Sydney, NSW, Australia; NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia. Department of Gastroenterology and Hepatology, The Alfred Hospital, Melbourne, VIC, Australia; Department of Gastroenterology and Hepatology, Epworth Hospital, Melbourne, VIC, Australia. Department of Gastroenterology and Hepatology, Westmead Hospital, Sydney, NSW, Australia; Westmead Clinical School, University of Sydney, Sydney, NSW, Australia. Electronic address: michael@citywestgastro.com.au.

The lancet. Gastroenterology & hepatology. 2021
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Abstract
BACKGROUND Endoscopic mucosal resection (EMR) is a cornerstone in the management of large (≥20 mm) non-pedunculated colorectal polyps. Clinically significant post-EMR bleeding occurs in 7% of cases and is most frequently encountered in the right colon. We aimed to assess the use of prophylactic clip closure in preventing clinically significant post-EMR bleeding within the right colon. METHODS We conducted a randomised controlled trial at a tertiary centre in Australia. Patients referred for the EMR of large non-pedunculated colorectal polyps in the right colon were eligible. Patients were randomly assigned (1:1) into the clip or control (no clip) group, using a computerised random-number generator. The primary endpoint was clinically significant post-EMR bleeding, defined as haematochezia necessitating emergency department presentation, hospitalisation, or re-intervention within 14 days post-EMR, which was analysed on the basis of intention-to-treat principles. The trial is registered with ClinicalTrials.gov, NCT02196649, and has been completed. FINDINGS Between Feb 4, 2016, and Dec 15, 2020, 231 patients were randomly assigned: 118 to the clip group and 113 to the control group. In the intention-to-treat analysis, clinically significant post-EMR bleeding was less frequent in the clip group than in the control group (four [3·4%] of 118 patients vs 12 [10·6%] of 113; p=0·031; absolute risk reduction 7·2% [95% CI 0·7-13·8]; number needed to treat 13·9). There were no differences between groups in adverse events, including delayed perforation (one [<1%] in the clip group vs one [<1%] in the control group) and post-EMR pain (four [3%] vs six [5%]). No deaths were reported. INTERPRETATION Prophylactic clip closure can be performed following the EMR of large non-pedunculated colorectal polyps of 20 mm or larger in the right colon to reduce the risk of clinically significant post-EMR bleeding. FUNDING None.
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Language : eng
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