Prospective, randomized multi-center trial. Comparison of Endoscopic Mucosal Resection (EMR) versus Endoscopic Full-Thickness Resection with the duodenal Full-Thickness Resection Device (dFTRD) of non-ampullary duodenal adenomas.
Prospective, randomized multi-center trial. Comparison of Endoscopic Mucosal Resection (EMR) versus Endoscopic Full-Thickness Resection with the duodenal Full-Thickness Resection Device (dFTRD) of non-ampullary duodenal adenomas.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Klinikum Ludwigsburg
Ludwigsburg, Baden-Wurttemberg, Germany
RECRUITINGComplication Rate
Composite endpoint of perforations and relevant bleeding
Time frame: 30 days
Technical success
Rate of macroscopic complete resections
Time frame: intraoperative
'R0'-Resection
Rate of microscopic complete resections
Time frame: within one week after resection (as soon as result of pathologic analysis of resected specimen is available)
Rate of 'en bloc' resections
Rate of 'en bloc' resections
Time frame: within one week after resection (as soon as result of pathologic analysis of resected specimen is available)
Need of secondary surgical intervention
Time frame: 3 months
Procedure time
time span of the procedure according to sedation protocol
Time frame: 30 days
Duration of hospitalization
Time frame: 30 days
number of patients with residual or recurrent duodenal adenoma at the follow-up endoscopy after 3 months
Time frame: 3 months
number of patients with residual or recurrent duodenal adenoma at the follow-up endoscopy after 1 year
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
number of necessary re-endoscopies
Time frame: 3 months