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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)

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ClinicalTrials.gov Identifier: NCT03559231
Recruitment Status : Unknown
Verified June 2018 by Kliniken Ludwigsburg-Bietigheim gGmbH.
Recruitment status was:  Recruiting
First Posted : June 18, 2018
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Kliniken Ludwigsburg-Bietigheim gGmbH

Study Description
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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.

Condition or disease Intervention/treatment Phase
Duodenal Adenoma Procedure: dFTRD Procedure: EMR Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : May 12, 2018
Estimated Primary Completion Date : June 12, 2020
Estimated Study Completion Date : May 12, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arms and Interventions
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Arm Intervention/treatment
Experimental: dFTRD
Endoscopic full-thickness resection of the duodenal adenoma with the 'duodenal Full-Thickness resection device' (dFTRD).
 Procedure: dFTRD
Duodenal Full-Thickness Resection
Active Comparator: EMR
Endoscopic Mucosal Resection (EMR) of the duodenal adenoma (=standard therapy).
 Procedure: EMR
Endoscopic Mucosal Resection


Outcome Measures
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Primary Outcome Measures :
  1. Complication Rate [ Time Frame: 30 days ]
    Composite endpoint of perforations and relevant bleeding


Secondary Outcome Measures :
  1. Technical success [ Time Frame: intraoperative ]
    Rate of macroscopic complete resections

  2. 'R0'-Resection [ Time Frame: within one week after resection (as soon as result of pathologic analysis of resected specimen is available) ]
    Rate of microscopic complete resections

  3. Rate of 'en bloc' resections [ Time Frame: within one week after resection (as soon as result of pathologic analysis of resected specimen is available) ]
    Rate of 'en bloc' resections

  4. Need of secondary surgical intervention [ Time Frame: 3 months ]
  5. Procedure time [ Time Frame: 30 days ]
    time span of the procedure according to sedation protocol

  6. Duration of hospitalization [ Time Frame: 30 days ]
  7. number of patients with residual or recurrent duodenal adenoma at the follow-up endoscopy after 3 months [ Time Frame: 3 months ]
  8. number of patients with residual or recurrent duodenal adenoma at the follow-up endoscopy after 1 year [ Time Frame: 1 year ]
  9. number of necessary re-endoscopies [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03559231


Contacts
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Contact: Markus Bauder, MD +49(0)7141-99-67201 markus.bauder@kliniken-lb.de
Contact: Karel Caca, MD, PhD +49(0)7141-99-67201 karel.caca@kliniken-lb.de

Locations
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Germany
Klinikum Ludwigsburg Recruiting
Ludwigsburg, Baden-Württemberg, Germany, 71640
Contact: Karel Caca, Prof. Dr. med.    +49(0)7141-99-67201    karel.caca@kliniken-lb.de   
Contact: Sandra Wennemuth    +49(0)7141-99-94473    sandra.wennemuth@kliniken-lb.de   
Sponsors and Collaborators
Kliniken Ludwigsburg-Bietigheim gGmbH
Investigators
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Study Chair: Karel Caca, MD, PhD Klinikum Ludwigsburg
More Information
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Responsible Party: Kliniken Ludwigsburg-Bietigheim gGmbH
ClinicalTrials.gov Identifier: NCT03559231    
Other Study ID Numbers: DUO-RESECT
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kliniken Ludwigsburg-Bietigheim gGmbH:
duodenal adenoma
FTRD
dFTRD
EMR
endoscopic mucosal resection
Additional relevant MeSH terms:
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Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms