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 Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Duodenal Adenoma

Intervention / Treatment
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* Procedure: dFTRD
* Procedure: EMR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dFTRD<br>Endoscopic full-thickness resection of the duodenal adenoma with the 'duodenal Full-Thickness resection device' (dFTRD). | Procedure: dFTRD<br>* Duodenal Full-Thickness Resection<br>|
| Active Comparator: EMR<br>Endoscopic Mucosal Resection (EMR) of the duodenal adenoma (=standard therapy). | Procedure: EMR<br>* Endoscopic Mucosal Resection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication Rate | Composite endpoint of perforations and relevant bleeding | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Rate of macroscopic complete resections | intraoperative | 
| 'R0'-Resection | Rate of microscopic complete resections | 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 | 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 | time span of the procedure according to sedation protocol | 30 days | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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duodenal adenoma, FTRD, dFTRD, EMR, endoscopic mucosal resection