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)

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 Overview

• Status: Unknown
• Conditions: Duodenal Adenoma
• Intervention / Treatment: Procedure: dFTRD; Procedure: EMR

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Markus Bauder, MD; Phone Number: +49(0)7141-99-67201; Email: markus.bauder@kliniken-lb.de
• Study Contact Backup: Name: Karel Caca, MD, PhD; Phone Number: +49(0)7141-99-67201; Email: karel.caca@kliniken-lb.de

Study Locations

• Germany
  • Baden-Württemberg
    • Ludwigsburg, Baden-Württemberg, Germany, 71640
      • Recruiting
      • Klinikum Ludwigsburg
      • Contact: Karel Caca, Prof. Dr. med.; Phone Number: +49(0)7141-99-67201; Email: karel.caca@kliniken-lb.de
      • Contact: Sandra Wennemuth; Phone Number: +49(0)7141-99-94473; Email: sandra.wennemuth@kliniken-lb.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kliniken Ludwigsburg-Bietigheim gGmbH
• Investigators: Study Chair: Karel Caca, MD, PhD, Klinikum Ludwigsburg

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2018
• Primary Completion (Anticipated): June 12, 2020
• Study Completion (Anticipated): May 12, 2021

Study Registration Dates

• First Submitted: May 11, 2018
• First Submitted That Met QC Criteria: June 5, 2018
• First Posted (Actual): June 18, 2018

Study Record Updates

• Last Update Posted (Actual): June 18, 2018
• Last Update Submitted That Met QC Criteria: June 5, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: EMR; endoscopic mucosal resection; FTRD; duodenal adenoma; dFTRD
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: DUO-RESECT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No