ETMI versus Chromoendoscopy in UC

Endoscopic trimodal imaging vs. chromoendoscopy as surveillance strategy for neoplasia in ulcerative colitis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22789

Enrollment

210

Registered

2013-07-04

Start date

2013-08-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Longstanding ulcerative colitis, colonic neoplasia Langdurige colitis ulcerosa, dikkedarm neoplasieën

Interventions

In this RCT we are comparing ETMI (endoscopic tri modal imaging) with chromoendoscopy in the detection of colonic neoplasia in ulcerative colitis. ETMI is a new endoscopy technique where three types o

Eligibility

Inclusion criteria

Inclusion criteria: - History of UC - Longstanding disease: extensive colitis >8 years (Montreal E3); or left-sided colitis >15 years (Montreal E2) - Age >18 years

Exclusion criteria

Exclusion criteria: - Change in bowel habits in the preceding two months (under maintenance therapy) - Personal history of (partial) colectomy - Clinically unfit for colonoscopy - Proven genetic predisposition for colorectal cancer - Currently known colonic neoplasia (e.g. referred patients or patients who refused treatment) - Known non-correctable coagulopathy that precludes taking biopsies (international normalized ratio >2; or platelet count 1 in at least one of the bowel segments - Poor bowel preparation (scoring <6 points on the Boston Bowel Preparation Scale) (24) - No informed consent

Design outcomes

Primary

Measure	Time frame
(1) to compare neoplasia detection rates of autofluorescence imaging (AFI) vs. chromoendoscopy (CE) in patients with ulcerative colitis. (2) to define the mean number of neoplastic lesions per patient.	—

Secondary

Measure	Time frame
(1) to compare endoscopic trimodal imaging (ETMI) vs. chromoendoscopy (CE) for differentiating neoplastic from non-neoplastic mucosa and (2) to identify diagnostic endoscopic and pathological markers for differentiation between inflammatory dysplasia, that harbour a significant risk on metachronous dysplasia and cancer and might require proctocolectomy, and a sporadic dysplastic lesion that can be safely removed by endoscopic resection.	—

Measure

Time frame

(1) to compare endoscopic trimodal imaging (ETMI) vs. chromoendoscopy (CE) for differentiating neoplastic from non-neoplastic mucosa and (2) to identify diagnostic endoscopic and pathological markers for differentiation between inflammatory dysplasia, that harbour a significant risk on metachronous dysplasia and cancer and might require proctocolectomy, and a sporadic dysplastic lesion that can be safely removed by endoscopic resection.

—

Contacts

Public ContactEvelien Dekker

Academic Medical Center (AMC) Department of Gastroenterology and Hepatology P.O. Box 22660

e.dekker@amc.uva.nl+31 (0)20 5664702

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)