NCT03559231
Unknown
Not Applicable
Endoscopic Resection of Non-ampullary Duodenal Adenomas: Endoscopic Mucosal Resection (EMR) vs. Endoscopic Full-thickness Resection With the 'Duodenal Full-thickness Resection Device' (dFTRD)
Kliniken Ludwigsburg-Bietigheim gGmbH1 site in 1 country100 target enrollmentMay 12, 2018
ConditionsDuodenal Adenoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Duodenal Adenoma
- Sponsor
- Kliniken Ludwigsburg-Bietigheim gGmbH
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Complication Rate
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Complication Rate
Time Frame: 30 days
Composite endpoint of perforations and relevant bleeding
Secondary Outcomes
- Need of secondary surgical intervention(3 months)
- 'R0'-Resection(within one week after resection (as soon as result of pathologic analysis of resected specimen is available))
- Rate of 'en bloc' resections(within one week after resection (as soon as result of pathologic analysis of resected specimen is available))
- Technical success(intraoperative)
- Procedure time(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 necessary re-endoscopies(3 months)
- number of patients with residual or recurrent duodenal adenoma at the follow-up endoscopy after 1 year(1 year)
Study Sites (1)
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