Endoscopic Resection of Non-ampullary Duodenal Adenomas: Endoscopic Mucosal Resection (EMR) vs. Endoscopic Full-thickness Resection With the 'Duodenal Full-thickness Resection Device' (dFTRD)
NCT ID: NCT03559231
Last Updated: 2018-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2018-05-12
2021-05-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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dFTRD
Endoscopic full-thickness resection of the duodenal adenoma with the 'duodenal Full-Thickness resection device' (dFTRD).
dFTRD
Duodenal Full-Thickness Resection
EMR
Endoscopic Mucosal Resection (EMR) of the duodenal adenoma (=standard therapy).
EMR
Endoscopic Mucosal Resection
Interventions
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dFTRD
Duodenal Full-Thickness Resection
EMR
Endoscopic Mucosal Resection
Eligibility Criteria
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Inclusion Criteria
* age 18 or older
* written informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Kliniken Ludwigsburg-Bietigheim gGmbH
OTHER
Responsible Party
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Principal Investigators
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Karel Caca, MD, PhD
Role: STUDY_CHAIR
Klinikum Ludwigsburg
Locations
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Klinikum Ludwigsburg
Ludwigsburg, Baden-Wurttemberg, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DUO-RESECT
Identifier Type: -
Identifier Source: org_study_id
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