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

Duodenal Adenoma Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03559231
• Other study ID #: DUO-RESECT
• Status: Recruiting
• Phase: N/A
• Start date: May 12, 2018
• Est. completion date: May 12, 2021

Study information

• Verified date: June 2018
• Source: Kliniken Ludwigsburg-Bietigheim gGmbH
• Contact: Markus Bauder, MD
• Phone: +49(0)7141-99-67201
• Email: markus.bauder[@]kliniken-lb.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 12, 2021
• Est. primary completion date: June 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Duodenal Adenoma

Intervention

Procedure:
• dFTRD
Duodenal Full-Thickness Resection
• EMR
Endoscopic Mucosal Resection

Locations

Country	Name	City	State
Germany	Klinikum Ludwigsburg	Ludwigsburg	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Kliniken Ludwigsburg-Bietigheim gGmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication Rate	Composite endpoint of perforations and relevant bleeding	30 days
Secondary	Technical success	Rate of macroscopic complete resections	intraoperative
Secondary	'R0'-Resection	Rate of microscopic complete resections	within one week after resection (as soon as result of pathologic analysis of resected specimen is available)
Secondary	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)
Secondary	Need of secondary surgical intervention		3 months
Secondary	Procedure time	time span of the procedure according to sedation protocol	30 days
Secondary	Duration of hospitalization		30 days
Secondary	number of patients with residual or recurrent duodenal adenoma at the follow-up endoscopy after 3 months		3 months
Secondary	number of patients with residual or recurrent duodenal adenoma at the follow-up endoscopy after 1 year		1 year
Secondary	number of necessary re-endoscopies		3 months