Amsterdam UMC
Amsterdam, North Holland, 1105 AZ, Netherlands
NCT Number: NCT06333093
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.
Looking for future studies?
Notify MeAll sexes
Interventional
Not applicable
Amsterdam, North Holland, 1105 AZ, Netherlands
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 (sub)mucosa. 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 (sub)mucosa.
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 Barrett's 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Two (2) cold snare resections of the duodenal mucosa during an already scheduled upper gastrointestinal interventional endoscopy under deep sedation (propofol).
Time frame: 1 day
Feasibility of acquiring adequate duodenual samples with the cold snare technique.
Time frame: 6 months
Ability to histopathologically assess the tissue.
Time frame: 3 months
The ability to dissociate the tissue to a sufficient degree to allow single cell RNA sequencing.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Other
Optimization of Duodenal Tissue Resection Acquisition Study
Acronym: DIRECT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01556399
Digestive System Diseases, Duodenal Diseases
Westmead, New South Wales, Australia
View Trial DetailsNCT06200129
Digestive System Diseases, Duodenal Diseases
Ankara, Turkey (Türkiye)
View Trial DetailsNCT03288831
Celiac Disease, Digestive System Diseases
Rochester, Minnesota, United States
View Trial DetailsNCT04673357
Crohn Disease, Digestive System Diseases
Wilmington, Delaware, United States
View Trial Details