Prophylactic clipping using the over-the-scope clip (OTSC) system after complex ESD and EMR of large colon polyps.

BACKGROUND: Delayed bleeding is the most frequent complication after endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR) of large colon polyps. Today, prophylactic clipping with through-the-scope clips (TTSCs) is commonly used to reduce the risk of bleeding. However, the over-the-scope clip (OTSC) system might be superior to TTSCs in achieving hemostasis. This study aims to evaluate the efficacy and safety of prophylactic clipping using the OTSC system after ESD or EMR of large colon polyps. METHODS: This is a retrospective analysis of a prospective collected database from 2009 until 2021 of three endoscopic centers. Patients with large (≥ 20 mm) colon polyps were enrolled. All polyps were removed by either ESD or EMR. After the resection, OTSCs were prophylactically applied on parts of the mucosal defect with a high risk of delayed bleeding or/and perforation. The main outcome measurement was delayed bleeding. RESULTS: A total of 75 patients underwent ESD (67%, 50/75) or EMR (33%, 25/75) in the colorectum. The mean resected specimen diameter was 57 mm ± 24.1 (range 22-98 mm). The mean number of OTSCs placed on the mucosal defect was 2 (range 1-5). None of the mucosal defects were completely closed. Intraprocedural bleeding occurred in 5.3% (ESD 2.0% vs. EMR 12.0%; P = 0.105), and intraprocedural perforation occurred in 6.7% (ESD 8% vs. EMR 4%; P = 0.659) of the patients. Hemostasis was achieved in 100% of cases of intraprocedural bleeding, whereas two patients required surgical conversion due to intraprocedural perforation. Among the remaining 73 patients who received prosphylactic clipping, delayed bleeding occurred in 1.4% (ESD 0% vs. EMR 4.2%; P = 0.329), and delayed perforation occurred in 0%. CONCLUSIONS: The prophylactic partial closure of large post-ESD/EMR mucosal defects using OTSCs could serve as an effective strategy to reduce the risk of delayed bleeding and perforation. The prophylactic partial closure of large complex post-ESD/EMR mucosal defects using OTSCs could serve as an effective strategy to reduce the risk of delayed bleeding and perforation.

The Role of Clips in Preventing Delayed Bleeding After Colorectal Polyp Resection: An Individual Patient Data Meta-Analysis.

BACKGROUND & AIMS: Nonpedunculated colorectal polyps are normally endoscopically removed to prevent neoplastic progression. Delayed bleeding is the most common major adverse event. Clipping the resection defect has been suggested to reduce delayed bleedings. Our aim was to determine if prophylactic clipping reduces delayed bleedings and to analyze the contribution of polyp characteristics, extent of defect closure, and antithrombotic use. METHODS: An individual patient data meta-analysis was performed. Studies on prophylactic clipping in nonpedunculated colorectal polyps were selected from PubMed, Embase, Web of Science, and Cochrane database (last selection, April 2020). Authors were invited to share original study data. The primary outcome was delayed bleeding ≤30 days. Multivariable mixed models were used to determine the efficacy of prophylactic clipping in various subgroups adjusted for confounders. RESULTS: Data of 5380 patients with 8948 resected polyps were included from 3 randomized controlled trials, 2 prospective, and 8 retrospective studies. Prophylactic clipping reduced delayed bleeding in proximal polyps ≥20 mm (odds ratio [OR], 0.62; 95% confidence interval [CI], 0.44-0.88; number needed to treat = 32), especially with antithrombotics (OR, 0.59; 95% CI, 0.35-0.99; number needed to treat = 23; subgroup of anticoagulants/double platelet inhibitors: n = 226; OR, 0.40; 95% CI, 0.16-1.01; number needed to treat = 12). Prophylactic clipping did not benefit distal polyps ≥20 mm with antithrombotics (OR, 1.41; 95% CI, 0.79-2.52). CONCLUSIONS: Prophylactic clipping reduces delayed bleeding after resection of nonpedunculated, proximal colorectal polyps ≥20 mm, especially in patients using antithrombotics. No benefit was found for distal polyps. Based on this study, patients can be identified who may benefit from prophylactic clipping. (PROSPERO registration number CRD42020104317.).

Prophylactic clipping not effective in preventing post-polypectomy bleeding for < 20-mm colon polyps: A multicenter, open-label, randomized controlled trial.

BACKGROUND AND AIM: Prophylactic clipping (PC) after polypectomy has the potential to prevent post-polypectomy bleeding (PPB). We aimed to evaluate the effectiveness of PC in preventing PPB for < 20-mm polyps. METHODS: This multicenter, open-label, randomized controlled trial conducted from December 2013 to June 2017 at 10 institutions randomly assigned 1080 patients with < 20-mm colon polyps to the non-PC and PC groups. Allocation factors were institution, antiplatelet drug use, and polyp number. The primary endpoint was differences in PPB rates between the groups. The severity of PPB and post-procedural abdominal symptoms were also investigated. These endpoints in intention-to-treat and per-protocol (PP) analyses were evaluated. RESULTS: We investigated 1039 patients with 2960 lesions. There was no significant difference between the groups in characteristics including age, sex, hypertension, diabetes, hyperlipidemia, antiplatelet drug use, and lesion characteristics such as type and size. Excluding the clip used in the non-PC group, intraoperative bleeding, and deviation of protocol, 903 patients were investigated in PP analysis. There was no significant difference in the PPB rate between the non-PC and PC groups (2.7% vs 2.3%, P = 0.6973 [intention-to-treat analysis]; 3.0 vs 2.4%, P = 0.7353 [PP analysis]). Severe PPB (≥ grade 3) was similar between the groups. Total procedure time was significantly shorter in the non-PC group than in the PC group (31 vs 36 min, P = 0.0002). Post-procedural abdominal fullness was less common in the non-PC group than in the PC group (20.8% vs 25.6%, P = 0.0833). CONCLUSION: Prophylactic clipping is not effective in preventing PBB for < 20-mm colon polyps (UMIN000012163).

Factors involved in endoscopists' choice for prophylactic clipping after colorectal endoscopic mucosal resection: a discrete choice experiment.

Background: Delayed bleeding (DB) occurs in ∼10% after colorectal EMR. Prophylactic clipping (PC) was reported to significantly decrease DB-rate in proximal lesions ≥2 cm.Objective: Our aim was to determine which predefined variables contribute to using PC in clinical practice.Methods: We performed an international discrete choice experiment (DCE) among ∼500 endoscopists. Relevant variables for PC use were selected by EMR experts: previous DB, anticoagulants, polyp size, morphology, location, intraprocedural bleeding and visible vessel(s). Respondents answered case scenarios with various variable combinations, each time choosing only one scenario for PC, or the 'none' option. Part-worth utilities and importance weights were calculated using HB regression. Subsequently, a predictive model was created to calculate the likelihood of endoscopists choosing PC in any given case.Results: The survey was completed by 190 EMR endoscopists from 17 countries. In total, 8% would never use PC, whereas 30.9% never chose the 'none' option. All variables except polyp type were significant in decision-making for PC (p < .01). The most important factor was anticoagulant use, accounting for 22.5% in decision-making. Polyps <2 cm were considered eligible for PC by 14% in the presence of high-weighing factors such as anticoagulant use. No significant differences were found between high and low-to-moderately experienced endoscopists.Conclusions: PC after EMR is often considered useful by endoscopists, usually based on risk factors for DB. Anticoagulant use was the most important factor in decision-making for PC, independent of endoscopist experience. Although not considered cost-effective, one in seven endoscopists chose PC for adenomas <2 cm.

Novel clip device for prevention of bleeding after endoscopic papillectomy.

Objectives: Recently, a novel clip device, SureClip® (Micro-Tech Co. Ltd., Nanjing, China), has been developed, which improved rotation and reopening performance. We aimed to assess the efficacy of the SureClip® in prophylactic closure of the mucosal break after endoscopic papillectomy (EP) for ampullary neoplasm. Methods: We retrospectively reviewed the medical records of 40 patients who underwent EP for ampullary neoplasms between October 2009 and March 2020. Prophylactic closure after resection was performed using the conventional clip between 2014 and 2018, and with the SureClip® after 2019. The baseline characteristics, techniques, outcomes, and complications of EP were analyzed. Results: The median age of the patients (25 males and 15 females) was 70 years. The en block resection rate was 82.5% and the curative resection rate was 80.0%. Histologically, 11 (27.5%) patients had malignancy. Prophylactic closure was performed in 29 (72.5%) patients (17 conventional clips, 12 SureClip®). Complications occurred in 18 (45.0%) patients, including postprocedure bleeding in 9 (22.5%) patients. However, no postprocedure bleeding was observed in the patients who received prophylactic closure using the SureClip® (p = 0.038). All other factors were not significantly correlated with postprocedure bleeding. The duration of hospital stay after EP was significantly shorter in patients treated with the SureClip® compared to those treated with a conventional clip or without clips (p < 0.05). Conclusions: In the present study, prophylactic clipping of the mucosal break using the SureClip® was effective in preventing bleeding after EP.

Clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (CLIPPER): study protocol for a randomized controlled trial.

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.