Rectum adenoma Rectum polyp
Conditions
Interventions
Eligible patients will receive LumenR-assisted ESD performed by an endoscopist
with sufficient ESD experience.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - The patient is diagnosed during a complete colonoscopy with a large non-pedunculated rectal adenoma (sessile or laterally spreading) with: • Diameter of >= 20mm and
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Endoscopic suspicion for submucosal invasive cancer, with for example one of the following characteristics: • Kudo pit pattern type V • Excavated/depressed type morphology (Paris type 0-IIc or 0-III) • Fold convergence • Large smooth nodule > 1 cm in a flat lesion - Histopathology or biopsy proven invasive or malignant disease - The targeted lesion consists of residual polypoiïd tissue after previous (endoscopic) treatment of this lesion - The patient is known with active inflammatory bowel disease (morbus Crohn or ulcerative colitis) of the colorectum. - Patients with suspicion of polyposis syndrome - Patients with a known irreversible coagulopathy, or patients with anticoagulational therapy (with warfarins, heparins, NOACS or double anti-platelet agents) for an indication wherefore temporarily cessation of the treatment is not possible. - Patients with active bleeding from any source - HIV-positive or immunocompromised patients - Patients who receive chemotherapy - Pregnant patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Our main study parameter is the number of en bloc resections and the en bloc resection rate after LumenR assisted ESD. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary parameters are designed to further study the efficacy and safety of LumenR assisted ESD: - Procedural time - Number of patients with a histological R0-resection - Adenoma recurrence rate at 6 months after the procedure - Number of procedures with cessation of the ESD procedure due to technical difficulties - Number of intra procedural complications (bleeding or perforation) for which an additional intervention, defined as transfusion, admission, radiologic intervention or surgical treatment is required. - Number of patients with early (48 hours) and late (until 14 days) post procedural complications for which additional treatment is necessary, defined as presentation at the emergency ward, transfusion, admission, repeat endoscopy, radiologic intervention or surgical treatment | — |
Countries
Netherlands
Outcome results
None listed