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Completed

NCT Number: NCT06333093

Duodenal tIssue ResEction aCquisiTion (DIRECT) Study

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam UMC

Amsterdam, North Holland, 1105 AZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Already scheduled to undergo an upper gastrointestinal interventional endoscopy
  • Endoscopy under deep sedation (propofol) in Amsterdam UMC

Exclusion criteria

  • 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

Treatment and study plan

Cold Snare

Procedure

Two (2) cold snare resections of the duodenal mucosa during an already scheduled upper gastrointestinal interventional endoscopy under deep sedation (propofol).

Primary outcomes

  1. Acquiring larger pieces of tissue from the duodenum

    Time frame: 1 day

    Feasibility of acquiring adequate duodenual samples with the cold snare technique.

  2. Histopatholocial assessment of larger pieces of tissue from the duodenum

    Time frame: 6 months

    Ability to histopathologically assess the tissue.

  3. Checking if the tissue is of good quality enough for single cell RNA sequencing

    Time frame: 3 months

    The ability to dissociate the tissue to a sufficient degree to allow single cell RNA sequencing.

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Official study title

Optimization of Duodenal Tissue Resection Acquisition Study

Acronym: DIRECT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2024
Registry last updated
Jan 15, 2026

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.

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