Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333093
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-02-21
Brief Title:
Duodenal tIssue ResEction aCquisiTion DIRECT Study
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Optimization of Duodenal Tissue Resection Acquisition Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIRECT
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
Detailed Description:
The duodenum plays an important role in metabolic health There is evidence that the duodenal mucosa undergoes certain histological changes in the development of features of the metabolic syndrome and ultimately type 2 diabetes T2D To date it is not known exactly what type of histological changes the duodenal mucosa undergoes in T2D so elucidating these changes may lead to a better understanding and potentially new treatment options for metabolic syndrome and T2D
The assessment of histological changes in tissue obtained from duodenal biopsies has proven to be very difficult due to the lack of orientation in the histological slides obtained The investigators have learned that duodenal biopsies are too small and superficial to reliably assess histological changes in the duodenal mucosa and submucosa Currently the investigators are taking small cold snare resections from the duodenum to try to fully assess the duodenal submucosa However the investigators still have problems with the orientation of these resections When slides are made the specimens are curled cut tangentially and artefacts occurr As a result it is still not possible to make a proper assessment of the duodenal submucosa
Therefore the investigators aim to optimise the process of obtaining storing processing and staining the duodenal mucosal tissue samples from cold snare resections The investigators plan to optimise this process in patients who have already undergone upper gastrointestinal interventional endoscopy including ablation therapy endoscopic submucosal dissection ESD or endoscopic mucosal resection EMR for Barretts neoplasia and squamous cell carcinoma of the oesophagus or small gastric neoplasia or oesophageal dilatations as the endoscopist performing DMR in the Netherlands also specialises in these endoscopic treatments By studying the process of obtaining duodenal mucosal tissue samples in this specific patient population there is no need to expose other patients to an upper gastrointestinal endoscopy with the associated propofol sedation
The assessment of histological changes in tissue obtained from duodenal biopsies has proven to be very difficult due to the lack of orientation in the histological slides obtained The investigators have learned that duodenal biopsies are too small and superficial to reliably assess histological changes in the duodenal mucosa and submucosa Currently the investigators are taking small cold snare resections from the duodenum to try to fully assess the duodenal submucosa However the investigators still have problems with the orientation of these resections When slides are made the specimens are curled cut tangentially and artefacts occurr As a result it is still not possible to make a proper assessment of the duodenal submucosa
Therefore the investigators aim to optimise the process of obtaining storing processing and staining the duodenal mucosal tissue samples from cold snare resections The investigators plan to optimise this process in patients who have already undergone upper gastrointestinal interventional endoscopy including ablation therapy endoscopic submucosal dissection ESD or endoscopic mucosal resection EMR for Barretts neoplasia and squamous cell carcinoma of the oesophagus or small gastric neoplasia or oesophageal dilatations as the endoscopist performing DMR in the Netherlands also specialises in these endoscopic treatments By studying the process of obtaining duodenal mucosal tissue samples in this specific patient population there is no need to expose other patients to an upper gastrointestinal endoscopy with the associated propofol sedation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None