Endoscopic Resection of Non-ampullary Duodenal Adenomas: Endoscopic Mucosal Resection (EMR) vs. Endoscopic Full-thickness Resection With the 'Duodenal Full-thickness Resection Device' (dFTRD)
DUO-RESECT
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2018
CompletedStudy Start
First participant enrolled
May 12, 2018
CompletedFirst Posted
Study publicly available on registry
June 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 12, 2021
CompletedJune 18, 2018
June 1, 2018
2.1 years
May 11, 2018
June 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complication Rate
Composite endpoint of perforations and relevant bleeding
30 days
Secondary Outcomes (9)
Technical success
intraoperative
'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)
Need of secondary surgical intervention
3 months
Procedure time
30 days
- +4 more secondary outcomes
Study Arms (2)
dFTRD
EXPERIMENTALEndoscopic full-thickness resection of the duodenal adenoma with the 'duodenal Full-Thickness resection device' (dFTRD).
EMR
ACTIVE COMPARATOREndoscopic Mucosal Resection (EMR) of the duodenal adenoma (=standard therapy).
Interventions
Eligibility Criteria
You may qualify if:
- duodenal adenoma
- age 18 or older
- written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Klinikum Ludwigsburg
Ludwigsburg, Baden-Wurttemberg, 71640, Germany
Study Officials
- STUDY CHAIR
Karel Caca, MD, PhD
Klinikum Ludwigsburg
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2018
First Posted
June 18, 2018
Study Start
May 12, 2018
Primary Completion
June 12, 2020
Study Completion
May 12, 2021
Last Updated
June 18, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share