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

Not Applicable

• Conditions: Duodenal Adenoma
• Interventions: Procedure: dFTRD; Procedure: EMR

• Registration Number: NCT03559231
• Lead Sponsor: Kliniken Ludwigsburg-Bietigheim gGmbH

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.

Study Timeline

• Study First Submitted: 2018-05-11
• Study Start: 2018-05-12
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-05
• Last Update Submitted: 2018-06-05
• Study First Posted: 2018-06-18
• Last Update Posted: 2018-06-18
• Primary Completion: 2020-06-12
• Study Completion: 2021-05-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• duodenal adenoma
• age 18 or older
• written informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dFTRD	dFTRD	Endoscopic full-thickness resection of the duodenal adenoma with the 'duodenal Full-Thickness resection device' (dFTRD).
EMR	EMR	Endoscopic Mucosal Resection (EMR) of the duodenal adenoma (=standard therapy).

Primary Outcome Measures

Name	Time	Method
Complication Rate	30 days	Composite endpoint of perforations and relevant bleeding

Secondary Outcome Measures

Name	Time	Method
Need of secondary surgical intervention	3 months
'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
Technical success	intraoperative	Rate of macroscopic complete resections
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 necessary re-endoscopies	3 months
number of patients with residual or recurrent duodenal adenoma at the follow-up endoscopy after 1 year	1 year

Trial Locations

Locations (1)

Klinikum Ludwigsburg; 🇩🇪 Ludwigsburg, Baden-Württemberg, Germany