adenoma polyp
Conditions
Interventions
In the EMR-arm, endoscopic resection will be performed using the EMR technique
(with APC or tipping in adjunct to pEMR), whereas patients randomized to the
ESD-arm will undergo resection using the E
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - to compare the recurrence rate at follow-up colonoscopy after 6 months, observed from resected residual disease or, if not present, from biopsies of the scar | — |
Secondary
| Measure | Time frame |
|---|---|
| - to compare the radical (R0-)resection rate, defined as dysplasia free vertical and lateral resection margins at histology - To compare the cost effectiveness at 36 months - To compare the perceived burden and quality of life among patients - To compare the surgical referral rate defined as the number of patients that are referred for surgical management at 36 months - To compare the complication rate - To compare the long-term recurrence rate at follow-up colonoscopy after 36 months, observed from resected residual disease or, if not present, from biopsies of the scar | — |
Countries
Netherlands
Outcome results
None listed