Duodenal Adenoma
Conditions
Keywords
duodenal adenoma, FTRD, dFTRD, EMR, endoscopic mucosal resection
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREdFTRD
Duodenal Full-Thickness Resection
PROCEDUREEMR
Endoscopic Mucosal Resection
Sponsors
Kliniken Ludwigsburg-Bietigheim gGmbH
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
* duodenal adenoma * age 18 or older * written informed consent
Exclusion criteria
* duodenal adenomas with a size \> 25 mm * duodenal adenomas with 20 mm or less distance to the major and/or minor duodenal papilla * presence of two or more duodenal adenomas * suspected or histologically confirmed malignancy * tumor disease (exception: after successful curative treatment) * conditions/diseases of the upper GI-tract that impair advancing of the devices into the duodenum * moribund patient * pregnancy and breastfeeding * patients that cannot give informed consent (e.g. psychiatric disorders, language barrier,...) * other contraindications for duodenal resections
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complication Rate | 30 days | Composite endpoint of perforations and relevant bleeding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 'R0'-Resection | within one week after resection (as soon as result of pathologic analysis of resected specimen is available) | Rate of microscopic complete resections |
| Rate of 'en bloc' resections | within one week after resection (as soon as result of pathologic analysis of resected specimen is available) | Rate of 'en bloc' resections |
| Need of secondary surgical intervention | 3 months | — |
| Procedure time | 30 days | time span of the procedure according to sedation protocol |
| Technical success | intraoperative | Rate of macroscopic complete resections |
| 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 | — |
| Duration of hospitalization | 30 days | — |
Countries
Germany
Contacts
Primary ContactMarkus Bauder, MD
Backup ContactKarel Caca, MD, PhD
Outcome results
None listed