To evaluate the quality of cold snare biopsies specimens of duodenal mucosa tissue in patients undergoing an upper gastrointestinal interventional endoscopy under deep sedation to improve histological assessment of duodenal mucosa in general and…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Duodenum weefsel
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Not applicable.
Background summary
The evaluation of histological changes in tissue obtained by duodenal biopsies
has proven to be very difficult due to lack of orientation in acquired
histological slides. We also learned that duodenal biopsies are too small and
superficial to reliably assess histological changes in duodenal mucosa and
submucosa. Currently, we collect small cold snare biopsies from the duodenum to
be able to fully assess the duodenal mucosa. However, we still experience
problems in the orientation of these mucosal resections. When sections are
made, the specimens are curled, cut tangential and artefacts develop. This
makes it still impossible to make a proper assessment of duodenal mucosa.
Therefore we would like to optimize the process of obtaining, storing,
processing and staining the duodenal mucosal tissue samples after cold snare
biopsies.
Study objective
To evaluate the quality of cold snare biopsies specimens of duodenal mucosa
tissue in patients undergoing an upper gastrointestinal interventional
endoscopy under deep sedation to improve histological assessment of duodenal
mucosa in general and specifically for future DMR studies.
Study design
Single site (Amsterdam UMC) open-label study
- No randomization
- Patients that are planned to undergo an upper gastrointestinal interventional
endoscopy under deep sedation with propofol sedation.
- Obtaining 2 additional duodenal mucosal cold snare biopsies during this
esophageal ESD or EMR procedure.
- Patients follow-up by standard of care, no study follow-up.
Study burden and risks
There is no extra burden for the participants, at most that they are sedated a
little longer. The additional risk consists of undergoing 2 cold snare
biopsies, preceded by submucosal lifting.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82178.018.22 |