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New endoscopic imaging techniques for the differentiation of polyps in the colon.

Narrow Band Imaging (NBI), Autofluorescence imaging (AFI), Chromoendoscopy or Confocal Endomicroscopy for the differentiation of adenomas and non-neoplastic polyps?

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON22060
Enrollment
85
Registered
2010-05-28
Start date
2008-02-01
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

None listed

Sponsors

Academic Medical Centre, Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Previous (serrated) adenoma(s) on colonoscopy; 2. Previous colon carcinoma for which partial colectomy was performed; 3. Hereditary non-polyposis colorectal cancer (either genetically proven by a mutation in one of the mismatch repair genes or with a clinical diagnosis according to the Amsterdam II criteria); 4. Positive family history for CRC; 5. Known present (serrated) adenoma(s) or colorectal cancer.

Exclusion criteria

Exclusion criteria: 1. Pregnancy; 2. Beta-blocker use; 3. Non-correctable coagulopathy precluding biopsies; 4. Age under 18 years; 5. Inability to give informed consent.

Design outcomes

Primary

MeasureTime frame
1. The feasibility of confocal endomicroscopy; represented by: A. The sensitivity and specificity of optical biopsies (using final histopathology as gold standard). The sensitivity and specificity will be calculated for both the real time endoscopy diagnosis and the blinded assessment afterwards; B. In addition, the percentage of confocal images with insufficient image quality for histopathological diagnosis will be calculated on a per lesion basis.

Secondary

MeasureTime frame
The accuracies of CE, NBI, AFI and confocal endomicroscopy for the endoscopic differentiation of detected lesions will be compared with final histopathology as gold standard.

Contacts

Public ContactT. Kuiper

Meibergdreef 9

t.kuiper@amc.uva.nl+31 (0)20 5664571

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)