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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56844
Enrollment
34
Registered
2024-06-13
Start date
2024-06-23
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease

Interventions

The intervention is endoscopic sampling of the rectum, colon and ileum. The only deviation from routine clinical practice is the cold snare biopsy of the specific segment.

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 17, 2026