Randomized comparison of endoscopic trimodal imaging versus chromoendoscopy guided confocal laser endomicroscopy as surveillance strategy for neoplasia in inflammatory bowel disease of the colon.

Randomized comparison of endoscopic trimodal imaging versus chromoendoscopy guided confocal laser endomicroscopy as surveillance strategy for neoplasia in inflammatory bowel disease of the colon. - ETMI vs CCLE in IBD

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33215

Enrollment

235

Registered

2009-11-17

Start date

2009-07-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Colon cancer dysplasia

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with inflammatory bowel disease for more than 8 years. Patients older than 18 year.

Exclusion criteria

Exclusion criteria: Personal history of (partial) colectomy. Contraindications for the use of intravenous fluorescein ( allergy, pregnancy or breastfeeding, sever cardiopulmonary disease or renal failure). Currently known colonic neoplasia (e.g. referred patient or patients who refused treatment of neoplasia in the past). Non-correctable coagulopathy that precludes taking biopsies (international normalized ratio >2 or platelet count

Design outcomes

Primary

Measure	Time frame
To compare endoscopic trimodal imaging (ETMI) vs. chromoendoscopy-guided confocal laser endomicroscopy (CCLE) for differentiating neoplastic from non-neoplastic mucosa in patients with ulcerative colitis (UC).	—

Secondary

Measure	Time frame
(1) Compare neoplasia detection rates of autofluorescence imaging (AFI) vs. chromoendoscopy (CE) and (2) identify diagnostic endoscopic markers for differentiation between dysplasia associated lesions/masses (DALMs) and adenoma-like masses (ALMs)	—

Countries

Netherlands

Outcome results