Optimization of Duodenal tIssue ResEction aCquisiTion (DIRECT) study

Recruiting

• Conditions: Duodenum weefsel; duodenal tissue acquisistion; obtaining gut tissue

• Registration Number: NL-OMON53392
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Patients are eligible, when they are already scheduled to undergo an upper
gastrointestinal interventional endoscopy under deep sedation (propofol) at the
Amsterdam UMC.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Previous GI surgery that could affect the ability to reach the duodenum via
endoscopy, such as Bilroth 2, Roux-en-Y gastric bypass, or other similar
procedures or conditions
- History of duodenal inflammatory diseases including Crohn*s Disease and
Celiac Disease

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Feasibility of acquiring adequate histological samples, including<br /><br>- Endoscopic cold snare biopsy of duodenal tissue<br /><br>- Fixation of the specimens<br /><br>- Slicing and staining of the samples<br /><br><br /><br>Ability to acquire adequate orientation of the tissue slides of the duodenal<br /><br>mucosa, in order to<br /><br>- Measure length of villi and crypts<br /><br>- Measure thickness of the mucosal layers<br /><br>- Determine density of certain stained cells/proteins.<br /><br><br /><br>Size and depth of cold snare biopsy tissue slides of the duodenal mucosa.<br /><br><br /><br>Weight of the cold snare tissue.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable.</p><br>