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Dual Focus NBI and pCLE in FAP Related Duodenal Adenoma

NCT02162173 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2014-06-12

No results posted yet for this study

Summary

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%

Conditions

  • Complication of Diagnostic Procedure
  • Adverse Effect of Diagnostic Agents, Subsequent Encounter

Interventions

PROCEDURE

Endoscopy

Endoscopist performed white light endoscopy for polyp detection, then switch to dual focus NBI for characterization. Then probe-based confocal laser endomicroscopy was applied for characterization by another endoscopist independently and finally biopsy.

Sponsors & Collaborators

  • King Chulalongkorn Memorial Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-11-30

Countries

  • Thailand

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02162173 on ClinicalTrials.gov