Duodenal AdenomaDUO-RESECTNCT03559231
Endoscopic Resection of Non-ampullary Duodenal Adenomas: Endoscopic Mucosal Resection (EMR) vs. Endoscopic Full-thickness Resection With the 'Duodenal Full-thickness Resection Device' (dFTRD)
A study testing dFTRD and EMR in people with Duodenal Adenoma, run by Kliniken Ludwigsburg-Bietigheim gGmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Duodenal Adenoma
- What is being tested?
- dFTRD and EMR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 12 May 2018to 12 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- duodenal adenoma
- age 18 or older
- written informed consent
Who cannot join
- 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
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- moribund patient
- pregnancy and breastfeeding
- patients that cannot give informed consent (e.g. psychiatric disorders, language barrier,...)
- other contraindications for duodenal resections
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinikum Ludwigsburg
Ludwigsburg, Baden-Wurttemberg, 71640
Karel Caca, Prof. Dr. med., +49(0)7141-99-67201, karel.caca@kliniken-lb.de
Sandra Wennemuth, +49(0)7141-99-94473, sandra.wennemuth@kliniken-lb.de
About this study
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.
Read the 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.
- Conditions
- Duodenal Adenoma
- Being tested
- dFTRD, EMR
- Keywords
- duodenal adenoma, FTRD, dFTRD, EMR, endoscopic mucosal resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dFTRDProcedure or surgery
Duodenal Full-Thickness Resection
EMRProcedure or surgery
Endoscopic Mucosal Resection
| Study group | Role | What they receive |
|---|---|---|
| dFTRD | Experimental | Endoscopic full-thickness resection of the duodenal adenoma with the 'duodenal Full-Thickness resection device' (dFTRD). Receives: Procedure: dFTRD |
| EMR | Active comparator | Endoscopic Mucosal Resection (EMR) of the duodenal adenoma (=standard therapy). Receives: Procedure: EMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication Rate
Composite endpoint of perforations and relevant bleeding
Measured: 30 days
Secondary outcomes (9)
Technical success
Rate of macroscopic complete resections
Measured: intraoperative
'R0'-Resection
Rate of microscopic complete resections
Measured: within one week after resection (as soon as result of pathologic analysis of resected specimen is available)
Rate of 'en bloc' resections
Rate of 'en bloc' resections
Measured: within one week after resection (as soon as result of pathologic analysis of resected specimen is available)
Need of secondary surgical intervention
Measured: 3 months
Procedure time
time span of the procedure according to sedation protocol
Measured: 30 days
Duration of hospitalization
Measured: 30 days
number of patients with residual or recurrent duodenal adenoma at the follow-up endoscopy after 3 months
Measured: 3 months
number of patients with residual or recurrent duodenal adenoma at the follow-up endoscopy after 1 year
Measured: 1 year
number of necessary re-endoscopies
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start12 May 2018
- Primary completion12 Jun 2020 (estimated)
- Study completion12 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duodenal AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kliniken Ludwigsburg-Bietigheim gGmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karel Caca, MD, PhD, Study chair, Klinikum Ludwigsburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559231
- Sponsor's protocol ID
- DUO-RESECT
- Acronym
- DUO-RESECT
- Status last verified
- Jun 2018
- First submitted
- 11 May 2018
- Last updated
- 18 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03559231
- Acronym / sponsor ID
- DUO-RESECT / DUO-RESECT
- Conditions
- Duodenal Adenoma
- Keywords
- duodenal adenoma, FTRD, dFTRD, EMR, endoscopic mucosal resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kliniken Ludwigsburg-Bietigheim gGmbHUniversity, hospital or other
- Study start
- 12 May 2018 (actual)
- Primary completion
- 12 Jun 2020 (estimated)
- Study completion
- 12 May 2021 (estimated)
- First posted
- 18 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dFTRD | Experimental | Procedure: dFTRDEndoscopic full-thickness resection of the duodenal adenoma with the 'duodenal Full-Thickness resection device' (dFTRD). |
| EMR | Active comparator | Procedure: EMREndoscopic Mucosal Resection (EMR) of the duodenal adenoma (=standard therapy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- duodenal adenoma
- age 18 or older
- written informed consent
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dFTRDDuodenal Full-Thickness Resection | Procedure or surgery | dFTRD |
| EMREndoscopic Mucosal Resection | Procedure or surgery | EMR |
Primary outcome
Complication Rate
Time frame: 30 days
Composite endpoint of perforations and relevant bleeding
9 secondary outcomes
Technical success
Time frame: intraoperative
'R0'-Resection
Time frame: within one week after resection (as soon as result of pathologic analysis of resected specimen is available)
Rate of 'en bloc' resections
Time frame: within one week after resection (as soon as result of pathologic analysis of resected specimen is available)
Need of secondary surgical intervention
Time frame: 3 months
Procedure time
Time frame: 30 days
Duration of hospitalization
Time frame: 30 days
number of patients with residual or recurrent duodenal adenoma at the follow-up endoscopy after 3 months
Time frame: 3 months
number of patients with residual or recurrent duodenal adenoma at the follow-up endoscopy after 1 year
Time frame: 1 year
number of necessary re-endoscopies
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karel Caca, MD, PhD study chair
Klinikum Ludwigsburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dFTRD and EMR in people with Duodenal Adenoma, run by Kliniken Ludwigsburg-Bietigheim gGmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Markus Bauder, MD (+49(0)7141-99-67201, markus.bauder@kliniken-lb.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication Rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2018.