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completed

Dual Focus NBI and pCLE in FAP Related Duodenal Adenoma

key information

study id #: NCT02162173

condition: Complication of Diagnostic Procedure , Adverse Effect of Diagnostic Agents, Subsequent Encounter

status: completed

purpose:

Background: Familial adenomatous polyposis (FAP) patients are at risk to develop periampullary and non-ampullary adenoma. Either a routine biopsy or an endoscopic removal of the lesion is generally required to identify the presence of adenoma. However, the risk of tissue sampling from the ampulla is high and non-ampullary polyps are sometimes numerous, therefore resecting all the lesions is time consuming. To support the PIVI (Preservation and Incorporation of Valuable endoscopic Innovations) initiative, a real-time diagnosis with NPV>= 90% is required.

Objective: To evaluate the diagnostic values of duodenal adenoma by dual focus NBI (dNBI) and probe-based confocal endomicroscopy (pCLE) in FAP patients.

Design: Diagnostic study.

Setting: Single tertiary-care referral center.

Patients: Twenty-six patients with previously diagnosed with FAP.

Intervention: Surveillance EGD with dNBI and pCLE. A real time adenoma reading was done by two different endoscopists for each of the technique. Histology from the matched lesion was used as the gold standard.

Main outcome measurements: Sensitivity, specificity, positive predictive value (PPV), and accuracy. With the threshold for negative predictive value (NPV) >= 90%

intervention: Procedure: Endoscopy

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