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)

Kliniken Ludwigsburg-Bietigheim gGmbH

Status: Unknown

Conditions: Duodenal Adenoma

Treatments: Procedure: dFTRD; Procedure: EMR

Study type: Interventional

Funder types: Other

Identifiers

NCT03559231

DUO-RESECT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

dFTRD

Experimental group

Description:

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

Treatment:

Procedure: dFTRD

EMR

Active Comparator group

Description:

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

Treatment:

Procedure: EMR