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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT03559231

Studienbeginn:
Mai 2018

Letztes Update:
18.06.2018

Wirkstoff:
-

Indikation (Clinical Trials):
Adenoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Kliniken Ludwigsburg-Bietigheim gGmbH

Collaborator:
-

Studienleiter

Karel Caca, MD, PhD
Study Chair
Klinikum Ludwigsburg

Kontakt

Markus Bauder, MD
Kontakt:
Phone: +49(0)7141-99-67201
E-Mail: markus.bauder@kliniken-lb.de» Kontaktdaten anzeigen

Karel Caca, MD, PhD
Kontakt:
Phone: +49(0)7141-99-67201
E-Mail: karel.caca@kliniken-lb.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Klinikum Ludwigsburg
71640 Ludwigsburg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Karel Caca, Prof. Dr. med.
Phone: +49(0)7141-99-67201
E-Mail: karel.caca@kliniken-lb.de

Sandra Wennemuth
Phone: +49(0)7141-99-94473
E-Mail: sandra.wennemuth@kliniken-lb.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Complication Rate (Time Frame - 30 days):
Composite endpoint of perforations and relevant bleeding

Secondary outcome:

1. Technical success (Time Frame - intraoperative):
Rate of macroscopic complete resections

2. 'R0'-Resection (Time Frame - within one week after resection (as soon as result of pathologic analysis of resected specimen is available)):
Rate of microscopic complete resections

3. Rate of 'en bloc' resections (Time Frame - within one week after resection (as soon as result of pathologic analysis of resected specimen is available)):
Rate of 'en bloc' resections

4. Need of secondary surgical intervention (Time Frame - 3 months)

5. Procedure time (Time Frame - 30 days):
time span of the procedure according to sedation protocol

6. Duration of hospitalization (Time Frame - 30 days)

7. number of patients with residual or recurrent duodenal adenoma at the follow-up endoscopy after 3 months (Time Frame - 3 months)

8. number of patients with residual or recurrent duodenal adenoma at the follow-up endoscopy after 1 year (Time Frame - 1 year)

9. number of necessary re-endoscopies (Time Frame - 3 months)

Studien-Arme

Experimental: dFTRD
Endoscopic full-thickness resection of the duodenal adenoma with the 'duodenal Full-Thickness resection device' (dFTRD).
Active Comparator: EMR
Endoscopic Mucosal Resection (EMR) of the duodenal adenoma (=standard therapy).

Geprüfte Regime

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

Quelle: ClinicalTrials.gov

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