Prophylactic clipping for the prevention of bleeding following wide-field endoscopic mucosal resection of laterally spreading colorectal lesions: an economic modeling study

Background and study aims: Clinically significant bleeding (CSPEB) is the most common adverse event following endoscopic mucosal resection (EMR) of large sessile and laterally spreading colorectal lesions (LSLs), and is associated with morbidity and resource utilization. CSPEB occurs more frequently with proximal LSLs. Prophylactic clipping of the post-EMR defect may be beneficial in CSPEB prevention. The aim of this study was to determine the cost-effectiveness of a prophylactic clipping strategy. We hypothesized that prophylactic clipping in the proximal colon was cost-effective.

Patients and methods: An economic model was applied to outcomes from the Australian Colonic Endoscopic Mucosal Resection (ACE) Study. Clip distances of 3, 5, 8, and 10 mm were analyzed. The cost of treating CSPEB was determined from an independent costing agency. The funds needed to spend (FNS) was the cost incurred in order to prevent one episode of CSPEB. A break-even analysis was performed to determine cost equivalence of the costs of clipping and CSPEB.

Results: Outcomes of 1717 LSLs (mean size 35.8 mm; 52.6 % proximal colon) that underwent EMR were analyzed. The overall rate of CSPEB was 6.4 % (proximal 8.9 %; distal 3.7 %). Endoscopic management was required in 45 % of CSPEB episodes. With a clip distance of 3 mm, the expected cost of prophylactic clipping was € 1106 per lesion compared with € 157 per lesion for the expected cost of CSPEB without clipping. At 100 % clipping efficacy, the FNS was € 14 826 (proximal and distal lesions € 9309 and € 29 540, respectively). A clip price of € 10.35 was required for the cost of clipping to offset the cost of CSPEB.

Conclusions: A prophylactic clipping strategy is not cost-effective and at present cannot be justified for all lesions or selectively for lesions in the proximal colon.

Trial registration: ClinicalTrials.gov (NCT01368289).

• References

• 1 Moss A, Bourke MJ, Williams SJ et al. Endoscopic mucosal resection outcomes and prediction of submucosal cancer from advanced colonic mucosal neoplasia. Gastroenterology 2011; 140: 1909-1918
• 2 Moss A, Williams SJ, Hourigan LF et al. Long-term adenoma recurrence following wide-field endoscopic mucosal resection (WF-EMR) for advanced colonic mucosal neoplasia is infrequent: results and risk factors in 1000 cases from the Australian Colonic EMR (ACE) study. Gut 2015; 64: 57-65
• 3 Ahlenstiel G, Hourigan LF, Brown G et al. Actual endoscopic versus predicted surgical mortality for treatment of advanced mucosal neoplasia of the colon. Gastrointest Endosc 2014; 80: 668-676
• 4 Swan MP, Bourke MJ, Alexander S et al. Large refractory colonic polyps: is it time to change our practice? A prospective study of the clinical and economic impact of a tertiary referral colonic mucosal resection and polypectomy service (with videos). Gastrointest Endosc 2009; 70: 1128-1136
• 5 Metz AJ, Bourke MJ, Moss A et al. Factors that predict bleeding following endoscopic mucosal resection of large colonic lesions. Endoscopy 2011; 43: 506-511
• 6 Buchner AM, Guarner-Argente C, Ginsberg GG. Outcomes of EMR of defiant colorectal lesions directed to an endoscopy referral center. Gastrointest Endosc 2012; 76: 255-263
• 7 Burgess NG, Metz AJ, Williams SJ et al. Risk factors for intraprocedural and clinically significant delayed bleeding after wide-field endoscopic mucosal resection of large colonic lesions. Clin Gastroenterol Hepatol 2014; 12: 651-661 (e651–653)
• 8 Liaquat H, Rohn E, Rex DK. Prophylactic clip closure reduced the risk of delayed postpolypectomy hemorrhage: experience in 277 clipped large sessile or flat colorectal lesions and 247 control lesions. Gastrointest Endosc 2013; 77: 401-407
• 9 Burgess NG, Williams SJ, Hourigan LF et al. A management algorithm based on outcomes of clinically significant delayed bleeding after wide-field endoscopic mucosal resection of large colonic lesions. Clin Gastroenterol Hepatol 2014; 12: 1525-1533
• 10 Quintanilla E, Castro JL, Rabago LR et al. Is the use of prophylactic hemoclips in the endoscopic resection of large pedunculated polyps useful? A prospective and randomized study. J Interv Gastroenterol 2012; 2: 99-104
• 11 Shioji K, Suzuki Y, Kobayashi M et al. Prophylactic clip application does not decrease delayed bleeding after colonoscopic polypectomy. Gastrointest Endosc 2003; 57: 691-694
• 12 Zhang QS, Han B, Xu JH et al. Clip closure of defect after endoscopic resection in patients with larger colorectal tumors decreased the adverse events. Gastrointest Endosc 2015; 82: 904-909
• 13 Moss A, Bourke MJ, Kwan V et al. Succinylated gelatin substantially increases en bloc resection size in colonic EMR: a randomized, blinded trial in a porcine model. Gastrointest Endosc 2010; 71: 589-595
• 14 Moss A, Bourke MJ, Metz AJ. A randomized, double-blind trial of succinylated gelatin submucosal injection for endoscopic resection of large sessile polyps of the colon. Am J Gastroenterol 2010; 105: 2375-2382
• 15 Anderson MA, Ben-Menachem T, Gan SI et al. Management of antithrombotic agents for endoscopic procedures. Gastrointest Endosc 2009; 70: 1060-1070
• 16 Moy RL, Waldman B, Hein DW. A review of sutures and suturing techniques. J Dermatol Surg Oncol 1992; 18: 785-795
• 17 Landsman S, Sherris M. Risk measures and insurance premium principles. Insur Math Econ 2001; 29: 103-115
• 18 Rice N, Smith P. Approaches to capitation and risk adjustment in health care: an international survey. Centre for Health Economics, The University of York; 1999 Available from: https://www.york.ac.uk/che/pdf/op38.pdf
• 19 Independent Hospital Pricing Authority. Independent review of the round 16 national hospital cost data collection. Melbourne: PricewaterhouseCoopers; 2013 Available from: https://www.ihpa.gov.au/sites/g/files/net636/f/publications/nhcdc-indp-fin-review-r16.pdf
• 20 Souleles N. Consumer response to the Reagan tax cuts. J Public Econ 2002; 85: 99-120
• 21 Berger-Thomson L, Chung E, McGibbin R. Estimating marginal propensities to consume in Australia using micro data. Econ Rec 2010; 86 (Suppl. 01) 49-60
• 22 Dobrowolski S, Dobosz M, Babicki A et al. Prophylactic submucosal saline-adrenaline injection in colonoscopic polypectomy: prospective randomized study. Surg Endosc 2004; 18: 990-993
• 23 Lee CK, Lee SH, Park JY et al. Prophylactic argon plasma coagulation ablation does not decrease delayed postpolypectomy bleeding. Gastrointest Endosc 2009; 70: 353-361
• 24 Paspatis GA, Paraskeva K, Theodoropoulou A et al. A prospective, randomized comparison of adrenaline injection in combination with detachable snare versus adrenaline injection alone in the prevention of postpolypectomy bleeding in large colonic polyps. Am J Gastroenterol 2006; 101: 2805
• 25 Choi KD, Jung HY, Lee GH et al. Application of metal hemoclips for closure of endoscopic mucosal resection-induced ulcers of the stomach to prevent delayed bleeding. Surg Endosc 2008; 22: 1882-1886
• 26 Iishi H, Tatsuta M, Narahara H et al. Endoscopic resection of large pedunculated colorectal polyps using a detachable snare. Gastrointest Endosc 1996; 44: 594-597
• 27 Kouklakis G, Mpoumponaris A, Gatopoulou A et al. Endoscopic resection of large pedunculated colonic polyps and risk of postpolypectomy bleeding with adrenaline injection versus endoloop and hemoclip: a prospective, randomized study. Surg Endosc 2009; 23: 2732-2737
• 28 Lee SH, Chung IK, Kim SJ et al. Comparison of postpolypectomy bleeding between epinephrine and saline submucosal injection for large colon polyps by conventional polypectomy: a prospective randomized, multicenter study. World J Gastroenterol 2007; 13: 2973-2977
• 29 Bahin FF, Naidoo M, Williams SJ et al. Prophylactic endoscopic coagulation to prevent bleeding after wide-field endoscopic mucosal resection of large sessile colon polyps. Clin Gastroenterol Hepatol 2015; 13: 724-730 (e722)
• 30 Pohl H. Clipping after polyp resection: uncertainties of a randomized trial. Gastrointest Endosc 2015; 82: 910-911
• 31 Corte C, Burger D, Horgan G et al. Postpolypectomy haemorrhage following removal of large polyps using mechanical hemostasis or epinephrine: a meta-analysis. United European Gastroenterol J 2014; 2: 123-130
• 32 Feagins LA, Spechler SJ. Use of hemoclips and other measures to prevent bleeding during colonoscopy by gastroenterologists in Veterans Affairs hospitals. Am J Gastroenterol 2014; 109: 288-290
• 33 Parikh ND, Zanocco K, Keswani RN et al. A cost-efficacy decision analysis of prophylactic clip placement after endoscopic removal of large polyps. Clin Gastroenterol Hepatol 2013; 11: 1319-1324
• 34 Waninger J, Kauffmann GW, Shah IA et al. Influence of the distance between interrupted sutures and the tension of sutures on the healing of experimental colonic anastomoses. Am J Surg 1992; 163: 319-323