Duodenal tIssue ResEction aCquisiTion (DIRECT) Study (DIRECT)

January 14, 2026 updated by: Jacques J.G.H.M. Bergman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Optimization of Duodenal Tissue Resection Acquisition 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 (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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1105 AZ
        • Amsterdam UMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cold snare resections
Two (2) cold snare resections of the duodenal mucosa during an already scheduled upper gastrointestinal interventional endoscopy under deep sedation (propofol).
Procedure: Cold snare
Two (2) cold snare resections of the duodenal mucosa during an already scheduled upper gastrointestinal interventional endoscopy under deep sedation (propofol).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acquiring larger pieces of tissue from the duodenum
Time Frame: 1 day
Feasibility of acquiring adequate duodenual samples with the cold snare technique.
1 day
Histopatholocial assessment of larger pieces of tissue from the duodenum
Time Frame: 6 months
Ability to histopathologically assess the tissue.
6 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Jacques JG Bergman, MD PhD, Amsterdam UMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2023

Primary Completion (Actual)

August 2, 2024

Study Completion (Actual)

August 2, 2024

Study Registration Dates

First Submitted

February 21, 2024

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 27, 2024

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL82178.018.22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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