Comparison of two new endoscopic techniques (endoscopic tri-modality imaging and chromoendoscopy-guided confocal laser endomicroscopy) with respect to their accuracy in colonoscopic surveillance in patients with ulcerative colitis.

Endoscopic trimodality imaging (ETMI) vs. chromoendoscopy-guided confocal laser endomicroscopy (CCLE) as surveillance strategy for neoplasia in ulcerative colitis.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON25794

Enrollment

235

Registered

2010-06-08

Start date

2010-09-01

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

None listed

Interventions

Group CCLE: Each part of the colon (ascending, transverse, descending, recto sigmoid) will be sprayed with 0.1% methylene blue solution on withdrawal of the endoscope. Excess of dye will be removed

10%) will be administered as contrast agent. Lastly, four quadrant random biopsies will be taken every 10 cm of colon. Before taking these biopsies, all random areas will be inspected by CE for asse

Eligibility

Inclusion criteria

Inclusion criteria: 1. History of UC; 2. Longstanding disease: extensive colitis >8 years; or left-sided colitis >15 years; 3. Age >18 years.

Exclusion criteria

Exclusion criteria: 1. Personal history of (partial) colectomy; 2. Contraindications for the use of intravenous fluorescein (allergy, pregnancy or breastfeeding, severe cardiopulmonary disease or renal failure); 3. Currently known colonic neoplasia (e.g. referred patients or patients who refused treatment severe cardiopulmonary disease or renal failure); 4. Non-correctable coagulopathy that precludes taking biopsies (international normalized ratio >2; or platelet count <90*109); 5. No informed consent.

Design outcomes

Primary

Measure	Time frame
Diagnostic accuracy (defined as sensitivity, specificity and overall accuracy) of AFI plus NBI vs. CCLE for the differentiation of neoplastic and non-neoplastic mucosa, using final histopathology as reference standard diagnosis.	—

Secondary

Measure	Time frame
1. Diagnostic accuracy of AFI plus NBI and CCLE to differentiate between dysplasia-associated dysplasia ('DALM') and sporadic adenomas ('ALMs'); DALMs are histologically proven neoplastic lesions with neoplasia in the adjacent ‘apparently normal’ mucosa, whereas ALMs do not demonstrate neoplasia in their adjacent mucosa; 2. Proportion of patients with neoplasia, defined as the number of patients with at least one histologically confirmed neoplastic colonic lesion divided by the total number of included patients; 3. Mean number of neoplastic lesions per included patient, defined as the number of histologically confirmed neoplastic lesions divided by the total number of included patients; 4. The yield of random biopsies, defined by the number of patients with neoplasia detected by random biopsies only (confirmed by histopathology); 5. Location of neoplasia (either intraepithelial or invasive) detected during prospective follow-up colonoscopies (colonic segment, distance ab ano, location with respect to a resection scar if visible) or in the resection specimen after proctocolectomy.	—

Measure

Time frame

1. Diagnostic accuracy of AFI plus NBI and CCLE to differentiate between dysplasia-associated dysplasia ('DALM') and sporadic adenomas ('ALMs'); DALMs are histologically proven neoplastic lesions with neoplasia in the adjacent ‘apparently normal’ mucosa, whereas ALMs do not demonstrate neoplasia in their adjacent mucosa; 2. Proportion of patients with neoplasia, defined as the number of patients with at least one histologically confirmed neoplastic colonic lesion divided by the total number of included patients; 3. Mean number of neoplastic lesions per included patient, defined as the number of histologically confirmed neoplastic lesions divided by the total number of included patients; 4. The yield of random biopsies, defined by the number of patients with neoplasia detected by random biopsies only (confirmed by histopathology); 5. Location of neoplasia (either intraepithelial or invasive) detected during prospective follow-up colonoscopies (colonic segment, distance ab ano, location with respect to a resection scar if visible) or in the resection specimen after proctocolectomy.

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Contacts

Public ContactE. Dekker

PO Box 22700

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

Outcome results