Abstract
BackgroundEndoscopic mucosal resection (EMR) is currently the most used technique for resection of large distal colorectal polyps. However, in large lesions EMR can often only be performed in a piecemeal fashion resulting in relatively low radical (R0)-resection rates and high recurrence rates. Endoscopic submucosal dissection (ESD) is a newer procedure that is more difficult resulting in a longer procedural time, but is promising due to the high en-bloc resection rates and the very low recurrence rates. We aim to evaluate the (cost-)effectiveness of ESD against EMR on both short (i.e. 6 months) and long-term (i.e. 36 months). We hypothesize that in the short-run ESD is more time consuming resulting in higher healthcare costs, but is (cost-) effective on the long-term due to lower patients burden, a higher number of R0-resections and lower recurrence rates with less need for repeated procedures.MethodsThis is a multicenter randomized clinical trial in patients with a non-pedunculated polyp larger than 20 mm in the rectum, sigmoid, or descending colon suspected to be an adenoma by means of endoscopic assessment. Primary endpoint is recurrence rate at follow-up colonoscopy at 6 months. Secondary endpoints are R0-resection rate, perceived burden and quality of life, healthcare resources utilization and costs, surgical referral rate, complication rate and recurrence rate at 36 months. Quality-adjusted-life-year (QALY) will be estimated taking an area under the curve approach and using EQ-5D-indexes. Healthcare costs will be calculated by multiplying used healthcare services with unit prices. The cost-effectiveness of ESD against EMR will be expressed as incremental cost-effectiveness ratios (ICER) showing additional costs per recurrence free patient and as ICER showing additional costs per QALY.DiscussionIf this trial confirms ESD to be favorable on the long-term, the burden of extra colonoscopies and repeated procedures can be prevented for future patients.Trial registrationNCT02657044 (Clinicaltrials.gov), registered January 8, 2016.
Highlights
Endoscopic mucosal resection (EMR) is currently the most used technique for resection of large distal colorectal polyps
In adenomas larger than 2 cm in size EMR can often only be performed in a piecemeal fashion due to the limited size of the snare, difficulty to position the endoscope, and often extension of the polyp over one or multiple folds [5, 6]
It is important to address this gap in the current knowledge, especially that screening programs have been widely introduced and the detection of large adenomas will further increase. The aim of this randomized clinical trial is to evaluate the effectiveness and cost-effectiveness of Endoscopic submucosal dissection (ESD) against EMR on both short (i.e. 6 months) and long-term (i.e. 36 months) for large (>20 mm) distal non-pedunculated adenomas. This randomized clinical trial will randomize between ESD and EMR in patients with large distal nonpedunculated colorectal adenomas
Summary
Endoscopic mucosal resection (EMR) is currently the most used technique for resection of large distal colorectal polyps. In large lesions EMR can often only be performed in a piecemeal fashion resulting in relatively low radical (R0)-resection rates and high recurrence rates. We hypothesize that in the short-run ESD is more time consuming resulting in higher healthcare costs, but is (cost-) effective on the long-term due to lower patients burden, a higher number of R0-resections and lower recurrence rates with less need for repeated procedures. Piecemeal resection lowers the reliability of assessing the dysplasia free resection margins (R0 resection) at histology. This is reflected by the relative high recurrence rate at follow-up colonoscopy after EMR ranging between 1216 %, and even increasing up to 30 % in nonpedunculated polyps exceeding 40 mm in size [7, 8]
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