rectal cancer rectal adenoma endoscopic submucosal dissection Transanal Minimally Invasive Surgery endeldarm kanker endeldarm poliep
Conditions
Interventions
In the TAMIS-arm, resection will be performed using the TAMIS technique, whereas patients randomised to the ESD-arm will undergo resection using the ESD technique.
Sponsors
Leiden University Medical Centre
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the ‘background’ criteria and at least one of the ‘specific’ criteria: Background criteria o Non-pedunculated polyp in the rectum where the bulk of the lesion is below 15cm from the anal verge found at colonoscopy o ≥18 years old o Written informed consent Specific criteria o Any degree of suspicion of early invasion: An endoscopic, ultrasound or MRI diagnosis of benign adenoma cannot be made with an estimated accuracy of >98%. o Lesions of any size with an estimated >2% likelihood of harbouring a focus of minimally invasive (sm1) T1 carcinoma due to the presence of any one of the following features: o LST-NG o LST-G >4cm o A Kudo Vi-type or Vn-type pit pattern (Vn-type pit pattern must be limited to an area of 1cm nodule within a LST-G lesion o Large protruded-type lesions o Irregular surface o Easy bleeding o Lower lying areas within the lesion suspicious for depression LST-NG: Laterally spreading tumour non granular; LST-G: Laterally spreading tumour granular.
Exclusion criteria
Exclusion criteria: o Endoscopic, ultrasound or MRI features of advanced disease (T stage >=2 or N stage >=1). Where there is discordance in the results, the optical endoscopic evaluation will be given the most weight and the case discussed by an expert panel of four study participants. o Prior endoscopic resection attempt o The risk exceeds the benefit of endoscopic treatment, such as patients with an extremely poor general condition or a very short life expectancy o The inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative recurrence rate at follow-up rectoscopy after 6 and 12 months, histologically confirmed from resected visible residual disease or, if not present, from biopsies of the scar. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Radical (R0-) resection rate, defined as dysplasia free vertical and lateral resection margins at histology • To compare the perceived burden of the treatment and quality of life among patients (see study procedures for questionnaires that will be used) • Overall complication rate* • Surgical referral rate defined as the number of patients that are referred for trans abdominal surgical management at 12 months • Cost effectiveness at 24 months. Costs will be calculated from a hospital perspective, including costs of (repeat) surgery and hospital stay. The difference in costs will be compared to the difference in local recurrence and the difference in quality-adjusted life years (QALYs). | — |
Contacts
Public ContactJames Hardwick
Outcome results
None listed