Cold snare biopsies in the ileum and colon for translational studies in inflammatory bowel disease: a feasibility study

Conditions: Inflammatory Bowel Disease
10017969

Registration Number: NL-OMON56844

Lead Sponsor: Amsterdam UMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 34

Inclusion Criteria

Inflammatory Bowel Disease (IBD) (Crohn*s disease (CD) or ulcerative colitis
(UC)) patients who are planned to undergo a routine IBD colonoscopy with the
collection of biopsies for disease activity assessment; >=18 years old; active
disease (defined as Mayo>1 for UC or SES-CD>2 for CD); ability to provide
informed consent.

Exclusion Criteria

Complete remission; history of colonic perforation during endoscopic
procedures; active use of anticoagulant medications; familial history of
bleeding disorders; known individual bleeding disorders; suspicion of dysplasia
or colorectal carcinoma.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Sample quality will be assessed based on the measure of cell yield, which<br /><br>quantifies the number of cells obtained in the biopsy samples. A higher cell<br /><br>yield typically indicates better sample quality, making it a key metric for<br /><br>evaluating the effectiveness of the biopsy procedures. In addition, the<br /><br>different cell types present in the biopsies will be analysed.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Significant intra-procedural bleeding: as objectified by the endoscopist<br /><br>Post-procedural bleeding: defined as rectal blood-loss that requires<br /><br>re-colonoscopy: persistent bleeding (>2 days after procedure)<br /><br>Perforation (objectified on cross-sectional imaging)<br /><br>Infection: defined as formation of an abscess, appendicitis or peritonitis<br /><br>Other adverse events related to the biopsy procedure (abdominal pain, cramps)<br /><br>Patient discomfort</p><br>