Dual Focus NBI and pCLE in FAP Related Duodenal Adenoma

NCT02162173 | Completed DMC

• 1 other identifier: RP007
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Familial adenomatous polyposis syndrome; Non-ampullary polyp; Ampullary polyp; Narrow band imaging endoscopy; Confocal laser endomicroscopy

Outcome Measures

Primary Outcomes (1)

• duodenal adenoma diagnosis

  1 year

Study Arms (1)

Endoscopy

EXPERIMENTAL

All patients underwent the same endoscopy.

Procedure: Endoscopy

Interventions

Endoscopy PROCEDURE

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.

Also known as: White light endoscopy, dual focus NBI endoscopy, probe-based confocal laser endomicroscopy, biopsy

Endoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older with a history of FAP
• Patients who able to provide a written informed consent.

You may not qualify if:

• Evidence of coagulopathy (INR ≥ 1.5 and/or platelet \< 80,000)
• Other bleeding tendency precluding biopsy
• Pregnancy
• allergy to fluorescein sodium

Sponsors & Collaborators

• King Chulalongkorn Memorial Hospital: lead

Study Sites (1)

King Chulalongkorn Memorial Hospital

Patumwan, Bangkok, 10330, Thailand

Location

Related Publications (1)

• Pittayanon 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 DERIVED

MeSH Terms

Conditions

Adenomatous Polyposis Coli

Interventions

Endoscopy; Biopsy

Condition Hierarchy (Ancestors)

Adenomatous Polyps; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Polyposis; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 9, 2014
• First Posted: June 12, 2014
• Study Start: December 1, 2012
• Primary Completion: November 1, 2013
• Last Updated: June 12, 2014

Record last verified: 2014-06

Locations

TH (1)