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• W3086627745 abstract "We read with interest the meta-analysis by Spadaccini et al on the use of prophylactic clipping after endoscopic resection of colonic polyps to prevent delayed postpolypectomy bleeding (DPPB).1Spadaccini M. et al.Gastroenterology. 2020; 159: 148-158Abstract Full Text Full Text PDF PubMed Scopus (17) Google Scholar The authors concluded, based on pooled data from randomized controlled trials (RCTs), that prophylactic clipping is beneficial in preventing DPPB for large proximal polyps. Previous meta-analyses of RCTs on this topic did not demonstrate a benefit of prophylactic clipping in all-comers, nor was there sufficient data to perform subgroup analyses among higher risk subgroups.2Forbes N. et al.J Can Assoc Gastroenterol. 2019; 2: 105-117Crossref PubMed Google Scholar However, in 2019, the results of several well-designed RCTs were published,3Pohl H. et al.Gastroenterology. 2019; 157: 977-984.e3Abstract Full Text Full Text PDF PubMed Scopus (70) Google Scholar, 4Feagins L.A. et al.Gastroenterology. 2019; 157: 967-976.e1Abstract Full Text Full Text PDF PubMed Scopus (32) Google Scholar, 5Albeniz E. et al.Gastroenterology. 2019; 157: 1213-1221.e4Abstract Full Text Full Text PDF PubMed Scopus (38) Google Scholar further elucidating the efficacy of this practice among large and proximal lesions. Although we agree that prophylactic clipping may be efficacious in reducing DPPB for right-sided polyps ≥20 mm, endoscopists should be made aware of important issues with this review. Firstly, studies examining different procedures were pooled together. Osada et al6Osada T. et al.Surg Endosc. 2016; 30: 4438-4444Crossref PubMed Scopus (17) Google Scholar assessed outcomes after endoscopic submucosal dissection (ESD) in the colon, and Zhang et al7Zhang Q.S. et al.Gastrointest Endosc. 2015; 82: 904-909Abstract Full Text Full Text PDF PubMed Scopus (72) Google Scholar studied patients undergoing ESD and endoscopic mucosal resection (EMR). Colorectal ESD is a distinct procedure usually reserved for higher risk lesions and is known to be associated with greater risks than EMR.8Fujiya M. et al.Gastrointest Endosc. 2015; 81: 583-595Abstract Full Text Full Text PDF PubMed Scopus (163) Google Scholar Thus, we believe these studies should not have been pooled with trials focused on EMR. When pooled, data from Zhang et al in particular may have increased the perceived beneficial effect of clipping. Data acquired from the authors demonstrate that in lesions of all sizes, 0 of 33 clipped ESD patients experienced DPPB versus 2 of 29 unclipped ESD patients.7Zhang Q.S. et al.Gastrointest Endosc. 2015; 82: 904-909Abstract Full Text Full Text PDF PubMed Scopus (72) Google Scholar Second, in Figure 4, the relative risk of DPPB with clipping is reported for both proximal and distal polyps. However, the authors incorrectly reported study findings from Matsumoto et al,9Matsumoto M. et al.Dig Endosc. 2016; 28: 570-576Crossref PubMed Scopus (36) Google Scholar reversing data from proximal and distal polyps. In actuality, for patients with proximal polyps, 11 in the clipping arm experienced DPPB whereas 5 in the nonclipping arm experienced DPPB.9Matsumoto M. et al.Dig Endosc. 2016; 28: 570-576Crossref PubMed Scopus (36) Google Scholar Substituting the correct data would likely result in a nonsignificant overall pooled relative risk for proximal polyps, which would importantly alter the authors’ conclusions on the efficacy of clipping in this subgroup. More important, the authors omitted any discussion of the contribution of observational data. Whilst we are in no way questioning the methodological superiority of the RCT, the true effects of prophylactic clipping cannot be adequately addressed without some consideration of results from observational studies. It is well-established that positive results derived from RCTs are often not generalizable to real-world practice,10Sherman R.E. et al.N Engl J Med. 2016; 375: 2293-2297Crossref PubMed Scopus (811) Google Scholar especially for complex interventions such as endoscopic clipping. As these authors have demonstrated, the biggest derived benefit of clipping exists in patients with proximal polyps ≥20 mm. In this population, the pooled relative risk of DPPB based on RCTs is 0.47 with clipping, compared to without (95% confidence interval, 0.24–0.95).3Pohl H. et al.Gastroenterology. 2019; 157: 977-984.e3Abstract Full Text Full Text PDF PubMed Scopus (70) Google Scholar, 4Feagins L.A. et al.Gastroenterology. 2019; 157: 967-976.e1Abstract Full Text Full Text PDF PubMed Scopus (32) Google Scholar, 5Albeniz E. et al.Gastroenterology. 2019; 157: 1213-1221.e4Abstract Full Text Full Text PDF PubMed Scopus (38) Google Scholar Our group recently published an analysis of a large historical cohort of >8300 colonoscopies involving polypectomy, performed by 47 endoscopists.11Forbes N. et al.Am J Gastroenterol. 2020; 115: 774-782Crossref PubMed Scopus (6) Google Scholar In the subgroup of 416 patients who underwent removal of one or more proximal polyp(s) ≥20 mm, the adjusted odds ratio of DPPB with clipping was 1.22 (95% confidence interval, 0.37–4.30).11Forbes N. et al.Am J Gastroenterol. 2020; 115: 774-782Crossref PubMed Scopus (6) Google Scholar Although underpowered, our findings would nevertheless suggest that prophylactic clipping, when used by real-world endoscopists in real-world settings, may not be effective as the randomized data would indicate. Importantly, the DPPB rate in this subgroup of otherwise healthy screening patients was 3.3%, much lower than the 6.9% observed in the recent RCTs evaluating this subgroup.3Pohl H. et al.Gastroenterology. 2019; 157: 977-984.e3Abstract Full Text Full Text PDF PubMed Scopus (70) Google Scholar, 4Feagins L.A. et al.Gastroenterology. 2019; 157: 967-976.e1Abstract Full Text Full Text PDF PubMed Scopus (32) Google Scholar, 5Albeniz E. et al.Gastroenterology. 2019; 157: 1213-1221.e4Abstract Full Text Full Text PDF PubMed Scopus (38) Google Scholar Thus, one must consider the clinical context, including the baseline bleeding risk of the population, before applying substantive treatment effects derived from RCTs to other settings. Clip closure of postpolypectomy defects is ultimately discretionary based on these patient- and polyp-related factors. However, endoscopist-related factors cannot be overlooked. The skill level and experience of the endoscopist is a potential factor that may partially explain the observed discrepancies between randomized and observational findings. RCTs in endoscopy are typically conducted by world experts, as opposed to a mix of endoscopists with varying levels of expertise typically seen in observational settings. In fact, the only observational study that has ever demonstrated a benefit of prophylactic clipping described the experience of a single world expert in EMR.12Liaquat H. et al.Gastrointest Endosc. 2013; 77: 401-407Abstract Full Text Full Text PDF PubMed Scopus (176) Google Scholar In the current meta-analysis, the only RCT demonstrating a clear benefit in lesions ≥20 mm, or in proximal lesions, was one conducted by the same endoscopist, and involving other world experts.4Feagins L.A. et al.Gastroenterology. 2019; 157: 967-976.e1Abstract Full Text Full Text PDF PubMed Scopus (32) Google Scholar When one introduces other factors such as lesion size, location, or position that makes clip closure difficult or impossible, and the need to fully close defects to derive the full prophylactic benefit that even experts inconsistently achieve,5Albeniz E. et al.Gastroenterology. 2019; 157: 1213-1221.e4Abstract Full Text Full Text PDF PubMed Scopus (38) Google Scholar the translation of clipping efficacy derived from trials to clinical effectiveness in the real world becomes even less certain. Although we agree that prophylactic clipping is likely beneficial for a subset of large proximal colonic lesions that can be fully closed, we feel strongly that caution should be exercised when applying RCT evidence alone to real-world practice recommendations or costing models. Prophylactic Clipping After Colorectal Endoscopic Resection Prevents Bleeding of Large, Proximal Polyps: Meta-analysis of Randomized TrialsGastroenterologyVol. 159Issue 1PreviewThe benefits of prophylactic clipping to prevent bleeding after polypectomy are unclear. We conducted an updated meta-analysis of randomized trials to assess the efficacy of clipping in preventing bleeding after polypectomy, overall and according to polyp size and location. Full-Text PDF" @default.
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• W3086627745 title "When Evaluating the Benefit of Prophylactic Clipping Following Polypectomy, Not All of the Answers Are Found in Randomized Trials" @default.
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