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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dFTRD | Experimental | Endoscopic full-thickness resection of the duodenal adenoma with the 'duodenal Full-Thickness resection device' (dFTRD). |
|
| EMR | Active Comparator | Endoscopic Mucosal Resection (EMR) of the duodenal adenoma (=standard therapy). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dFTRD | Procedure | Duodenal Full-Thickness Resection |
| |
| EMR |
| Measure | Description | Time Frame |
|---|---|---|
| Complication Rate | Composite endpoint of perforations and relevant bleeding | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Rate of macroscopic complete resections | intraoperative |
| 'R0'-Resection | Rate of microscopic complete resections | within one week after resection (as soon as result of pathologic analysis of resected specimen is available) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Markus Bauder, MD | Contact | +49(0)7141-99-67201 | markus.bauder@kliniken-lb.de | |
| Karel Caca, MD, PhD | Contact | +49(0)7141-99-67201 | karel.caca@kliniken-lb.de |
| Name | Affiliation | Role |
|---|---|---|
| Karel Caca, MD, PhD | Klinikum Ludwigsburg | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Ludwigsburg | Recruiting | Ludwigsburg | Baden-Wurttemberg | 71640 | Germany |
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| Procedure |
Endoscopic Mucosal Resection |
|
| Rate of 'en bloc' resections | Rate of 'en bloc' resections | within one week after resection (as soon as result of pathologic analysis of resected specimen is available) |
| Need of secondary surgical intervention | 3 months |
| Procedure time | time span of the procedure according to sedation protocol | 30 days |
| Duration of hospitalization | 30 days |
| number of patients with residual or recurrent duodenal adenoma at the follow-up endoscopy after 3 months | 3 months |
| number of patients with residual or recurrent duodenal adenoma at the follow-up endoscopy after 1 year | 1 year |
| number of necessary re-endoscopies | 3 months |