EMR Versus ESD for Resection of Large Distal Non-pedunculated Colorectal Adenomas
- Conditions
- Colorectal Neoplasms
- Interventions
- Procedure: ESDProcedure: EMR
- Registration Number
- NCT02657044
- Lead Sponsor
- UMC Utrecht
- Brief Summary
Endoscopic resection of adenomas in the colon is the cornerstone of effective colorectal cancer prevention. Endoscopic mucosal resection (EMR) is currently the most used technique for resection of large distal colorectal adenomas, however, maintains some important limitations. In large lesions, EMR can often only be performed in a piecemeal fashion resulting in relatively low 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. The aim of this multicenter randomized study is to compare EMR and ESD with regard to recurrence rates and radical (R0) resection rates, and to put this into perspective against the costs and complication rates of both strategies and the burden perceived by patients on the long term-term.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 212
- non-pedunculated polyp larger than 20 mm in the rectum, sigmoid or descending colon found during colonoscopy
- indication for endoscopic treatment
- ≥18 years old
- Written informed consent
- suspicion of malignancy, as determined by endoscopic findings (invasive Kudo pit pattern, Hiroshima type C) or proven malignancy at histology
- prior endoscopic resection attempt
- presence of synchronous distal advanced carcinoma that requires surgical resection
- the risk exceeds the benefit of endoscopic treatment, such as patient's with an extremely poor general condition or a very short life expectancy
- the inability to provide informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ESD ESD In the ESD-arm, endoscopic resection will be performed using the (h)ESD technique. EMR EMR In the EMR-arm, endoscopic resection will be performed using the (p)EMR technique.
- Primary Outcome Measures
Name Time Method Recurrence rate at follow-up colonoscopy after 6 months 6 months Observed from resected residual disease or, if not present, from biopsies of the scar
- Secondary Outcome Measures
Name Time Method Long-term recurrence rate at follow-up colonoscopy after 36 months 36 months Observed from resected residual disease or, if not present, from biopsies of the scar
Health care resource utilization and consts 36 months 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.
Perceived burden and quality of life among patients 36 months Measurement of the patients' burden of ESD versus EMR will be evaluated with regard to colorectal cancer anxiety, burden of the procedure itself, functional complaints and overall quality of life. Meaurement will be performed using validated questionnaires.
Complication rate 30 days Complications will be assessed on day 30: intraprocedural perforation, Intraprocedural bleeding, Postprocedural bleeding, Postprocedural perforation, Postprocedural serositis.
Surgical referral rate 36 months Defined as the number of patients that are referred for surgical management at 36 months
R0-resection rate 30 days Defined as dysplasia free vertical and lateral resection margins at histology
Trial Locations
- Locations (1)
UMC Utrecht
🇳🇱Utrecht, Netherlands