Endoclips have been widely used to prevent complications such as delayed bleeding or perforation resulting from endoscopic resection. Delayed bleeding is defined as any clinically significant bleeding occurring within 30 days post procedure. Although there is controversy regarding the cost-benefit relationship of this practice, recent publications and guidelines have encouraged the use of endoclip placement as a prophylactic measure. Most studies have evaluated the prophylactic use of endoclips in the colon, given the increase in the number of screening colonoscopies, polypectomies and mucosectomies performed.
The use of the endoclip in resection of esophageal and gastric lesions is justified in situations post endoscopic resection where an active uncontrolled bleeding vessel or non-bleeding protuberant vessel is present at the resection site, or in suspected perforation. In other situations, such as patients on anticoagulation or antiplatelet therapy, in the presence of portal hypertension [ 36 ] or for lesions with a large pedicle or with large vessels, prophylactic endoclipping can also be considered in the esophagus or stomach. There are currently no high quality controlled clinical trials that recommend the preventive use of endoclips in these segments.
The effect of prophylactic mucosal closure after endoscopic resection is unclear. A study of 91 lesions enrolling 91 patients who underwent endoscopic resection for superficial non-ampullary duodenal tumors investigated the efficacy of prophylactic clipping for the prevention of late complications. Individuals were allocated to either an immediate clipping group or to a non-clipping group. Delayed bleeding occurred in 1 patient (2.1%) and delayed perforation occurred in 1 patient (2.1%) within the clipping group, whereas within the non-clipping group, delayed bleeding occurred in 6 patients (13.6%, P=0.053) and delayed perforation occurred in 3 patients (6.8%, P=0.350). Therefore, prophylactic clipping showed a tendency towards lower complication rates [ 40 ]. In view of the above, for resected duodenal lesions >10 mm, the recommendation is to close the resection site using endoclips to prevent delayed bleeding and perforation [ 38 - 41 ]. Notably, RCTs are needed to assess whether systematic clipping prophylaxis reduces the incidence of late complications after endoscopic resection. Given the infrequency of duodenal lesions and the difficulty of endoscopic resection, there have been few large-scale studies to date.
Multiple biopsies of superficial duodenal lesions should be avoided, as the resulting fibrosis may impair the lifting and removal of the target lesion during endoscopic treatment [ 39 ]. In the case of endoscopic therapy in the duodenum, polypectomy may be indicated in lesions ≤10 mm, and mucosectomy in lesions >10 mm.
Duodenal polyps or lesions, although rare, are increasingly being identified by endoscopy. The most frequent duodenal lesions are lipomas, gastrointestinal stromal tumors, neuroendocrine tumors, Brunner’s gland hamartomas, Peutz-Jeghers polyps and adenomas [ 37 ]. Endoscopic resection of duodenal lesions is technically more difficult and has a higher risk of immediate and delayed bleeding complications (14%) and perforation (1.9%) compared to elsewhere in the gastrointestinal tract. Most studies involve resection of superficial non-ampullary epithelial tumors (0.1-0.4%) [ 38 ]. Duodenal polypectomy or mucosectomy is technically challenging, because of the narrow lumen, the presence of peristalsis, loop formation and difficulty in device positioning, especially for lesions distal to the ampulla of Vater. Other contributing factors that render treatment difficult include the presence of a thinner muscularis propria layer, an extensive vascular plexus supplied by the gastroduodenal artery and the pancreatoduodenal arch, and the presence of Brunner’s glands in the submucosa, which may hinder the lifting of the target lesion during catheter injection [ 37 , 38 ].
Various polypectomy and mucosectomy techniques within the colon have been developed with advances in imaging technology and devices [42]. As a result, adverse events, especially bleeding and perforation, have also increased in absolute numbers. A meta-analysis that included 6529 colonoscopies involving mucosectomies showed a delayed bleeding rate of 4% and a perforation rate of 1.1% [43]. Patient-related perforation risk factors include the presence of diverticulosis, inflammatory bowel disease and corticosteroid use. The endoscopist’s experience and polyp morphology also influence the rate of adverse events. Risk factors described for bleeding after polypectomy include polyp size above 2 cm, right sided colonic polyps, intraprocedural bleeding, use of antithrombotic agents, and exposed vessels in the submucosa after resection [43,44]. The use of microprocessor-controlled electrocautery confers a lower risk of bleeding and perforation after polypectomy [45,46].
Endoclipping is not routinely indicated in the resection of colonic polyps <20 mm, because its use does not reduce the risk of postprocedural bleeding [42,47]. In an RCT enrolling 1499 patients, prophylactic clipping was not necessary to prevent post-polypectomy delayed bleeding for polyps <2 cm [48]. In another study, 1098 patients who had polyps ≥10 mm were randomly divided into 2 groups (clipping or non-clipping groups). The authors found that placement of prophylactic endoclips did not affect the incidence of delayed post-polypectomy bleeding [49]. On the other hand, a recent multicenter RCT with 919 patients, which evaluated the influence of endoscopic clipping of post-polypectomy defects >20 mm, showed that clipping reduced the overall risk of delayed hemorrhage. This benefit was limited to lesions in the proximal colon, where the bleeding risk was significantly lower when clips were applied compared to the control group (3.3% compared to 9.9%; P<0.001) [50].
A recent meta-analysis of 9 RCTs (7197 colorectal lesions) assessed the efficacy of clipping in preventing bleeding after polypectomy. The results showed that the benefit of clipping in reducing bleeding was significant for large polyps (clipped vs. unclipped, odds ratio [OR] 0.54, 95%CI 0.30-0.97; P=0.041), and proximal lesions >20 mm (clipped vs. unclipped, OR 0.34, 95%CI 0.19-0.65; P=0.021). Thus if such lesions were not clipped, there would be 4-fold increase in the baseline risk of post-polypectomy bleeding [51]. According to 2 American guidelines, in non-pedunculated polyps >20 mm, whose Paris classification is of type 0-Is or type 0-II [52], the closure of the endoscopic resection area with clips decreases the incidence of late bleeding, especially in the right colon [42,43] ( ).
In pedunculated polyps (Paris classification Ip), prophylaxis for bleeding post-polypectomy with endoclips is recommended in those in which the polyp head is ≥20 mm, or if the pedicle is ≥10 mm [46,53]. The American Society for Gastrointestinal Endoscopy (ASGE) guidelines recommend the prophylactic application of endoclips for resection of polyps with a pedicle greater than 5 mm [40]. ESGE guidelines also suggest the use of a diluted epinephrine injection as an alternative or in association with mechanical hemostasis in the pretreatment of polyps with a large pedicle [46].
The SCALP (Study on ComplicAtions of Large Polypectomy) study, which evaluated 1504 patients, found that prophylactic endoscopic clipping was cost-effective for polyps >10 mm in patients on anticoagulant or antiplatelet therapy. Anticoagulant therapy was the risk factor most associated with delayed bleeding [53]. In the case of periprocedural bleeding or exposure of submucosal vessels, endoscopic coagulation (snare-tip soft coagulation or coagulation forceps) or mechanical therapy (clips or endoloop) is recommended, with or without the combined use of dilute adrenaline injection [46] ( ).
Signs predictive of perforation, such as the “target sign” (representing injury to the colon’s muscularis propria after mucosectomy and identified as a white to grey central circular disk on the transected surface of the specimen) should prompt consideration of endoscopic closure of the defect ( ).
Although the direct costs related to delayed bleeding are largely unreported, a Spanish prospective series of 1424 endoscopic mucosal resections analyzed the cost-effectiveness of prophylactic clipping of large colorectal lesions (≥2 cm). In this study, bleeding costs were higher in relation to the prophylactic strategy in average and high-risk settings (age ≥75 years, American Society of Anesthesiologists classification III-IV, lesion size ≥40 mm, aspirin use, location of the lesion proximal to transverse colon) [54]. A recent publication evaluated the economic impact of prophylactic endoscopic clipping on large colonic polyps. It suggested that prophylactic clip closure after endoscopic resection of large colonic polyps, particularly those within the right colon, is cost-effective, but only if the clip device costs under $100.00 (USD) [55].
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