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Optimization of Duodenal tIssue ResEction aCquisiTion (DIRECT) study

Optimization of Duodenal tIssue ResEction aCquisiTion (DIRECT) study - DIRECT study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON53392
Enrollment
30
Registered
2022-12-05
Start date
2023-01-10
Completion date
Unknown
Last updated
2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duodenum weefsel duodenal tissue acquisistion obtaining gut tissue

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Not applicable.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)