Adenoma
Conditions
Keywords
adenoma, EMR, FTRD, non- lifting, colon
Brief summary
Adenomatous lesions of the colon are premalignant lesions which have the potential to develop cancer. Therefore adenomas should be resected endoscopically (endo- mucosa resection, EMR). EMR is conducted after submucosal injection of saline which allows to lift the desired lesion prior to resection. In some cases EMR is complicated due to incomplete or failed lifting after the injection of saline. This so- called non- lifting sign is a predictor for malignancy of the lesion. Difficult- to- lift polyps are also difficult- to- resect. A higher proportion of these lesions fail to be resected completely using the EMR technique. Alternatively, an over- the- scope full- thickness resection device (FTRD) can be used in order to resect colonic lesions. The FTRD technique has been described elsewhere (Schmidt et al. Gastroenterology 2014; 147: 740-742.e2). No comparative data exists until now on the performance of FTRD resection compared to standard EMR resection of difficult- to- resect colon adenomas. In this study the investigators aim to compare the success of FTRD versus EMR of difficult- to- resect adenomatous lesions (≤ 20 mm).
Interventions
DEVICEover- the- scope full- thickness resection device (FTRD)
Endoscopic resection of adenomatous lesions of the colon using the over- the- scope full- thickness resection device
DEVICEEMR
Standard endoscopic mucosal resection using a resection snare
Sponsors
Technical University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients ≥ 18 years * adenomatous lesion 10-20 mm in size with expected difficulties regarding EMR (e.g. non- lifting sign)
Exclusion criteria
* patients \< 18 years * lesions \> 20 mm in size * high risk carcinomas (deep submucosal carcinoma) * American Society of Anesthesiologists (ASA) class IV and higher
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success of resection | 3 month | Success of resection: Complete resection (R0) according to clinical and/or histopathological assessment |
Secondary
| Measure | Time frame |
|---|---|
| Duration of procedure | up to 1 day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day) |
Countries
Germany
Contacts
Primary ContactPeter Klare, MD
Backup ContactStefan von Delius, MD
Outcome results
None listed