Benign polyps benign tumors
Conditions
Interventions
The technique that will be assessed is called soft tip snare coagulation
(STSC). It requires the same equipment used with standard EMR or snare
polypectomy: polypectomy snare. In this technique, the
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: All patients aged >= 18 years with proven colorectal sessile of lateral spreading polyps (Paris classification 0-IIa/b/c, Is) with a diameter of >= 20mm requiring piecemeal resection with EMR are eligible for inclusion.
Exclusion criteria
Exclusion criteria: Previously attempted intervention Endoscopic appearance of invasive malignancy Histologically confirmed malignancy Presence or suspicion of inflammatory bowel disease En bloc resection Incomplete resection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this trial is to investigate whether thermal ablation EMR with soft tip snare coagulation (STSC) reduces the recurrence rate of lateral spreading or sessile polyps >=20mm compared to standard EMR. The primary endpoint therefore is polyp recurrence after 6 months follow up. Recurrence is evaluated histologically with biopsies taken during follow up colonoscopy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives are to evaluate the efficiency and safety of STSC EMR and to identify predictors for higher recurrence rates. We will also compare macroscopic with histologic recurrence evaluation. Therefore the following secondary objectives are formulated: Data on perforation, post procedural bleeding, post polypectomy syndrome and death are collected in order to further evaluate the safety EMR. EMR procedure time The procedure time of all EMR procedures will be recorded in order to compare duration between standard EMR and EMR with STSC. Localization The localization of each polyp will be described in the colonoscopy report: cecum, ascending colon, descending colon, transverse colon, and rectosigmoid colon. Localization will be assessed as a possible risk factor for recurrence. Polyp size All polyps will be measured during colonoscopy as size is reported to be an independent risk factor for polyp recurrence [1, 2]. Polyp histology All polyps will be classified according to the Kudo*s pit pattern classification [3], Paris classification [4] and Hiroshima classification [5] and NICE classification [6]. Macroscopic recurrence Recurrence is both macroscopically and microscopically assessed in clinical practice, depending on local protocols and preferences. In this study, we will compare both assessments. Intraprocedural bleeding Polyp or resection site bleeding during the EMR is also described to enhance the risk for recurrence [1, 7]. Health-related quality of life Data on quality of life will be collected at baseline and during follow up. Medical and non-medical costs. | — |
Countries
Netherlands
Outcome results
None listed