Clinical trial NCT03559231: Endoscopic Resection of Non-ampullary Duodenal Adenomas: Endoscopic Mucosal Resection (EMR) vs. Endoscopic Full-thickness Resection With the 'Duodenal Full-thickness Resection Device' (dFTRD)
Official title: Endoscopic Resection of Non-ampullary Duodenal Adenomas: Endoscopic Mucosal Resection (EMR) vs. Endoscopic Full-thickness Resection With the 'Duodenal Full-thickness Resection Device' (dFTRD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Duodenal Adenoma
Keywords: duodenal adenoma
FTRD
dFTRD
EMR
endoscopic mucosal resection
Lead sponsor: Kliniken Ludwigsburg-Bietigheim gGmbH
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Complication Rate
timeFrame: 30 days
Secondary outcomes:
measure: Technical success
timeFrame: intraoperative
measure: 'R0'-Resection
timeFrame: within one week after resection (as soon as result of pathologic analysis of resected specimen is available)
measure: Rate of 'en bloc' resections
timeFrame: within one week after resection (as soon as result of pathologic analysis of resected specimen is available)
measure: Need of secondary surgical intervention
timeFrame: 3 months
measure: Procedure time
timeFrame: 30 days
measure: Duration of hospitalization
timeFrame: 30 days
measure: number of patients with residual or recurrent duodenal adenoma at the follow-up endoscopy after 3 months
timeFrame: 3 months
measure: number of patients with residual or recurrent duodenal adenoma at the follow-up endoscopy after 1 year
timeFrame: 1 year
measure: number of necessary re-endoscopies
timeFrame: 3 months
Other outcomes:
Locations:
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg
state: Baden-Württemberg
Study officials:
affiliation: Klinikum Ludwigsburg
name: Karel Caca, MD, PhD
role: STUDY_CHAIR
References: