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Observational study; Confocal endomicroscopy in the diagnosis of colorectal neoplasia.

Observational study; Combined pan-chromoendoscopy and confocal endomicroscopy for the diagnosis of colorectal neoplasia in subjects at high-risk for colorectal cancer.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON29543
Enrollment
60
Registered
2007-10-01
Start date
2007-12-01
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

1. Colorectal cancer (coloncarcinoom)

Interventions

Both techniques (conventional colonoscopy and confocal endomicroscopy) are routinely used in clinical practice at the Department of Gastroenterology of our hospital. In this regard, patients participa

Sponsors

Dr. S. Sanduleanu, gastroenterologist University Hospital Maastricht Department of Gastroenterology and Hepatology PO BOX 5800, 6202 AZ Maastricht e-mail: sda@sint.azm.nl tel: 0031-43-3875021
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Clinical diagnostic criteria for either HNPCC (Amsterdam II criteria , Bethesda criteria or genetic criteria) or familial colorectal cancer type X – (1) CRC diagnosed age < 50 years; 2. at least 2 first-degree relatives with CRC regardless of age; 3. 1 first-degree and 1 second-degree relative with CRC regardless of age.

Exclusion criteria

Exclusion criteria: 1. Age < 18 years, presence of inflammatory bowel disease, or known polyposis syndromes; 2. Patients with incomplete endoscopic procedure due to anatomic or technique-related factors.

Design outcomes

Primary

MeasureTime frame
The primary outcome measure will be the number of patients with at least one adenoma after conventional colonoscopy compared with the number of patients with at least one adenoma after pan-chromoendoscopy.

Secondary

MeasureTime frame
Secondary outcome measures assessing the diagnostic accuracy of combined pan-chromoendoscopy and confocal endomicroscopy are: total number of lesions detected; number of adenomas; number of advanced adenomas; number of flat lesions detected.

Contacts

Public ContactS. Sanduleanu

University Hospital Maastricht Department of Gastroenterology and Hepatology PO BOX 5800

sda@sint.azm.nl+31 (0)43 3875021

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)