Duodenal tIssue ResEction aCquisiTion (DIRECT) Study
DIRECT
Optimization of Duodenal Tissue Resection Acquisition Study
1 other identifier
interventional
13
1 country
1
Brief Summary
To evaluate the quality of cold snare resection specimens of duodenal mucosa tissue in patients undergoing an upper gastrointestinal interventional endoscopy in order to improve the processing of histological samples and its assessment in general and for future duodenal ablation studies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2023
CompletedFirst Submitted
Initial submission to the registry
February 21, 2024
CompletedFirst Posted
Study publicly available on registry
March 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 2, 2024
CompletedJanuary 15, 2026
January 1, 2026
1.6 years
February 21, 2024
January 14, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Acquiring larger pieces of tissue from the duodenum
Feasibility of acquiring adequate duodenual samples with the cold snare technique.
1 day
Histopatholocial assessment of larger pieces of tissue from the duodenum
Ability to histopathologically assess the tissue.
6 months
Checking if the tissue is of good quality enough for single cell RNA sequencing
The ability to dissociate the tissue to a sufficient degree to allow single cell RNA sequencing.
3 months
Study Arms (1)
Cold snare resections
EXPERIMENTALTwo (2) cold snare resections of the duodenal mucosa during an already scheduled upper gastrointestinal interventional endoscopy under deep sedation (propofol).
Interventions
Two (2) cold snare resections of the duodenal mucosa during an already scheduled upper gastrointestinal interventional endoscopy under deep sedation (propofol).
Eligibility Criteria
You may qualify if:
- Already scheduled to undergo an upper gastrointestinal interventional endoscopy
- Endoscopy under deep sedation (propofol) in Amsterdam UMC
You may not qualify if:
- 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 condition
- History of duodenal inflammatory diseases including Crohn's Disease and Celiac Disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Amsterdam UMC
Amsterdam, North Holland, 1105 AZ, Netherlands
Related Publications (1)
Busch CBE, van den Hoek K, Neefjes-Borst EA, Nieuwdorp M, van Baar ACG, Bergman JJHGM. Optimizing duodenal tissue acquisition for mechanistic studies of duodenal ablation in type 2 diabetes. Endosc Int Open. 2025 Jan 29;13:a25032135. doi: 10.1055/a-2503-2135. eCollection 2025.
PMID: 40007651DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacques JG Bergman, MD PhD
Amsterdam UMC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Endoscopy and Principle Investigator
Study Record Dates
First Submitted
February 21, 2024
First Posted
March 27, 2024
Study Start
January 10, 2023
Primary Completion
August 2, 2024
Study Completion
August 2, 2024
Last Updated
January 15, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share