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

Sponsor

Kliniken Ludwigsburg-Bietigheim gGmbH (Other)

Overall Status

Unknown status

CT.gov ID

NCT03559231

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Duodenal Adenoma	Procedure: dFTRD Procedure: EMR	N/A

Detailed Description

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Primary Completion Date :

Jun 12, 2020

Anticipated Study Completion Date :

May 12, 2021

Arms and Interventions

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

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

Primary Outcome Measures

Complication Rate [30 days]
Composite endpoint of perforations and relevant bleeding

Secondary Outcome Measures

Technical success [intraoperative]
Rate of macroscopic complete resections
'R0'-Resection [within one week after resection (as soon as result of pathologic analysis of resected specimen is available)]
Rate of microscopic complete resections
Rate of 'en bloc' resections [within one week after resection (as soon as result of pathologic analysis of resected specimen is available)]
Rate of 'en bloc' resections
Need of secondary surgical intervention [3 months]
Procedure time [30 days]
time span of the procedure according to sedation protocol
Duration of hospitalization [30 days]
number of patients with residual or recurrent duodenal adenoma at the follow-up endoscopy after 3 months [3 months]
number of patients with residual or recurrent duodenal adenoma at the follow-up endoscopy after 1 year [1 year]
number of necessary re-endoscopies [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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