Wide-field endoscopic mucosal resection versus endoscopic submucosal dissection for laterally spreading colorectal lesions: a cost-effectiveness analysis.

OBJECTIVE: To compare the cost-effectiveness of endoscopic submucosal dissection (ESD) and wide-field endoscopic mucosal resection (WF-EMR) for removing large sessile and laterally spreading colorectal lesions (LSLs) >20 mm. DESIGN: An incremental cost-effectiveness analysis using a decision tree model was performed over an 18-month time horizon. The following strategies were compared: WF-EMR, universal ESD (U-ESD) and selective ESD (S-ESD) for lesions highly suspicious for containing submucosal invasive cancer (SMIC), with WF-EMR used for the remainder. Data from a large Western cohort and the literature were used to inform the model. Effectiveness was defined as the number of surgeries avoided per 1000 cases. Incremental costs per surgery avoided are presented. Sensitivity and scenario analyses were performed. RESULTS: 1723 lesions among 1765 patients were analysed. The prevalence of SMIC and low-risk-SMIC was 8.2% and 3.1%, respectively. Endoscopic lesion assessment for SMIC had a sensitivity and specificity of 34.9% and 98.4%, respectively. S-ESD was the least expensive strategy and was also more effective than WF-EMR by preventing 19 additional surgeries per 1000 cases. 43 ESD procedures would be required in an S-ESD strategy. U-ESD would prevent another 13 surgeries compared with S-ESD, at an incremental cost per surgery avoided of US$210 112. U-ESD was only cost-effective among higher risk rectal lesions. CONCLUSION: S-ESD is the preferred treatment strategy. However, only 43 ESDs are required per 1000 LSLs. U-ESD cannot be justified beyond high-risk rectal lesions. WF-EMR remains an effective and safe treatment option for most LSLs. TRIAL REGISTRATION NUMBER: NCT02000141.

Prediction of Clinically Significant Bleeding Following Wide-Field Endoscopic Resection of Large Sessile and Laterally Spreading Colorectal Lesions: A Clinical Risk Score.

OBJECTIVES: Clinically significant bleeding (CSPEB) is the most frequent adverse event following wide-field endoscopic mucosal resection (WF-EMR) of large sessile and laterally spreading colorectal lesions (LSL). There is limited knowledge regarding accurate prediction of CSPEB. We aimed to derive a score to predict the risk of CSPEB. METHODS: Data on patient and lesion characteristics and outcomes from WF-EMRs of LSL ≥20 mm at 8 referral hospitals were analyzed. The cohort was divided at random into equal sized training and test groups. Independent predictors of CSPEB in the training cohort were identified by multiple logistic regression analysis and used to develop a risk score. The performance of this score was assessed in the independent test cohort. RESULTS: Over 80 months to June 2015, 2,128 patients with 2,424 LSL were referred for WF-EMR. Two thousand and twelve patients were eligible for analysis. There were 135 cases of CSPEB (6.7%). In the training cohort of 1,006 patients, the independent predictors of CSPEB were lesion size >30 mm (odds ratio (OR) 2.5), proximal colonic location (OR 2.3), presence of a major comorbidity (OR 1.5), and epinephrine in injection solution (OR 0.57). The derived risk score comprised lesion size >30 mm (2 points), proximal colon (2 points), presence of major comorbidity (1 point), and absence of epinephrine use (1 point). The probabilities of CSPEB for scores of 0, 1, 2, 3, 4, and ≥5 in the training cohort were 1.5, 2.0, 5.6, 7.8, 9.1, and 17.5% and were 0.9, 6.7, 4.9, 6.2, 9.0, and 15.7% in the test cohort. The probabilities of CSPEB in those with low (score 0-1), medium (score 2-4), and elevated (score 5-6) risk levels were 1.7, 7.1, and 17.5% in the training cohort and 3.4, 6.2, and 15.7% in the test cohort. CONCLUSIONS: Patients at elevated risk of CSPEB can be identified using four readily available variables. This knowledge may improve the management of those undergoing WF-EMR and assist in designing studies evaluating CSPEB.

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 €â€Š1106 per lesion compared with €â€Š157 per lesion for the expected cost of CSPEB without clipping. At 100 % clipping efficacy, the FNS was €â€Š14 826 (proximal and distal lesions €â€Š9309 and €â€Š29 540, respectively). A clip price of €â€Š10.35 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).