Clinical trial · Interventional
Dual Focus NBI and pCLE in FAP Related Duodenal Adenoma
Diagnostic Values of Dual Focus Narrow Band Imaging and Probe-based Confocal Laser Endomicroscopy in FAP Related Duodenal Adenoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adverse Effect of Diagnostic Agents, Subsequent Encounter | — | UNRESOLVED | — |
| Complication of Diagnostic Procedure | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Endoscopy
- description
- All patients underwent the same endoscopy.
- interventionNames
- Procedure: Endoscopy
Primary outcomes (1)
- measure
- duodenal adenoma diagnosis
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or older with a history of FAP * Patients who able to provide a written informed consent. Exclusion Criteria: * Evidence of coagulopathy (INR ≥ 1.5 and/or platelet \< 80,000) * Other bleeding tendency precluding biopsy * Pregnancy * allergy to fluorescein sodium
References
Publications (1)
- DERIVEDPittayanon R, Rerknimitr R, Imraporn B, Wisedopas N, Kullavanijaya P. Diagnostic values of dual focus narrow band imaging and probe-based confocal laser endomicroscopy in FAP-related duodenal adenoma. Endosc Int Open. 2015 Oct;3(5):E450-5. doi: 10.1055/s-0034-1392235. Epub 2015 Jun 23. PMID 26528500