T1 coloncarcinoma
Conditions
Interventions
None listed
Sponsors
Isala
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Lesion macroscopic suspect for T1 colon carcinoma during endoscopy (Hiroshima 2-3) o Or histologically proven T1 colon carcinoma • Size 25cm proximal from the anus (measured endoscopically) • > 18 years old
Exclusion criteria
Exclusion criteria: • Rectal carcinoma • Distant metastasis at baseline • > 50% circumferential growth of the lesion - Prior endoscopic resection or attempt, lifting not included
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of oncologic resections for low-risk T1 colon carcinomas by using CAL-WR as primary treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Effectiveness (technically success and macroscopic- and microscopic R0 resection) of limited treatment approach - 3-year overall and disease free survival - 5-year overall and disease free survival - 30-day postoperative morbidity and mortality rate according to the Clavien-Dindo classification I-V - Total procedure related costs and cost effectiveness - Postoperative quality of life | — |
Countries
Netherlands
Contacts
Public ContactJ. Hanevelt
Isala
Outcome results
None listed