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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)

Primary Purpose

Duodenal Adenoma

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
dFTRD
EMR
Sponsored by
Kliniken Ludwigsburg-Bietigheim gGmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Duodenal Adenoma focused on measuring duodenal adenoma, FTRD, dFTRD, EMR, endoscopic mucosal resection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinikum LudwigsburgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

dFTRD

EMR

Arm Description

Endoscopic full-thickness resection of the duodenal adenoma with the 'duodenal Full-Thickness resection device' (dFTRD).

Endoscopic Mucosal Resection (EMR) of the duodenal adenoma (=standard therapy).

Outcomes

Primary Outcome Measures

Complication Rate
Composite endpoint of perforations and relevant bleeding

Secondary Outcome Measures

Technical success
Rate of macroscopic complete resections
'R0'-Resection
Rate of microscopic complete resections
Rate of 'en bloc' resections
Rate of 'en bloc' resections
Need of secondary surgical intervention
Procedure time
time span of the procedure according to sedation protocol
Duration of hospitalization
number of patients with residual or recurrent duodenal adenoma at the follow-up endoscopy after 3 months
number of patients with residual or recurrent duodenal adenoma at the follow-up endoscopy after 1 year
number of necessary re-endoscopies

Full Information

First Posted
May 11, 2018
Last Updated
June 5, 2018
Sponsor
Kliniken Ludwigsburg-Bietigheim gGmbH
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1. Study Identification

Unique Protocol Identification Number
NCT03559231
Brief 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)
Acronym
DUO-RESECT
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

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 12, 2018 (Actual)
Primary Completion Date
June 12, 2020 (Anticipated)
Study Completion Date
May 12, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kliniken Ludwigsburg-Bietigheim gGmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Duodenal Adenoma
Keywords
duodenal adenoma, FTRD, dFTRD, EMR, endoscopic mucosal resection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dFTRD
Arm Type
Experimental
Arm Description
Endoscopic full-thickness resection of the duodenal adenoma with the 'duodenal Full-Thickness resection device' (dFTRD).
Arm Title
EMR
Arm Type
Active Comparator
Arm Description
Endoscopic Mucosal Resection (EMR) of the duodenal adenoma (=standard therapy).
Intervention Type
Procedure
Intervention Name(s)
dFTRD
Intervention Description
Duodenal Full-Thickness Resection
Intervention Type
Procedure
Intervention Name(s)
EMR
Intervention Description
Endoscopic Mucosal Resection
Primary Outcome Measure Information:
Title
Complication Rate
Description
Composite endpoint of perforations and relevant bleeding
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Technical success
Description
Rate of macroscopic complete resections
Time Frame
intraoperative
Title
'R0'-Resection
Description
Rate of microscopic complete resections
Time Frame
within one week after resection (as soon as result of pathologic analysis of resected specimen is available)
Title
Rate of 'en bloc' resections
Description
Rate of 'en bloc' resections
Time Frame
within one week after resection (as soon as result of pathologic analysis of resected specimen is available)
Title
Need of secondary surgical intervention
Time Frame
3 months
Title
Procedure time
Description
time span of the procedure according to sedation protocol
Time Frame
30 days
Title
Duration of hospitalization
Time Frame
30 days
Title
number of patients with residual or recurrent duodenal adenoma at the follow-up endoscopy after 3 months
Time Frame
3 months
Title
number of patients with residual or recurrent duodenal adenoma at the follow-up endoscopy after 1 year
Time Frame
1 year
Title
number of necessary re-endoscopies
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Markus Bauder, MD
Phone
+49(0)7141-99-67201
Email
markus.bauder@kliniken-lb.de
First Name & Middle Initial & Last Name or Official Title & Degree
Karel Caca, MD, PhD
Phone
+49(0)7141-99-67201
Email
karel.caca@kliniken-lb.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karel Caca, MD, PhD
Organizational Affiliation
Klinikum Ludwigsburg
Official's Role
Study Chair
Facility Information:
Facility Name
Klinikum Ludwigsburg
City
Ludwigsburg
State/Province
Baden-Württemberg
ZIP/Postal Code
71640
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karel Caca, Prof. Dr. med.
Phone
+49(0)7141-99-67201
Email
karel.caca@kliniken-lb.de
First Name & Middle Initial & Last Name & Degree
Sandra Wennemuth
Phone
+49(0)7141-99-94473
Email
sandra.wennemuth@kliniken-lb.de

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Endoscopic Resection of Non-ampullary Duodenal Adenomas: Endoscopic Mucosal Resection (EMR) vs. Endoscopic Full-thickness Resection With the 'Duodenal Full-thickness Resection Device' (dFTRD)

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