Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dual Focus NBI and pCLE in FAP Related Duodenal Adenoma (PIVI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02162173
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : June 12, 2014
Sponsor:
Information provided by (Responsible Party):
Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital

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%


Condition or disease Intervention/treatment Phase
Complication of Diagnostic Procedure Adverse Effect of Diagnostic Agents, Subsequent Encounter Procedure: Endoscopy Not Applicable

Detailed Description:

Endoscopic procedure and criteria for adenoma diagnosis

  • The endoscopic diagnostic criteria to distinguish between adenoma and non-adenoma were adopted from the previous studies by Uchiyama Y et al. in 2006. A real time adenoma diagnosis was made by the two independent endoscopists (BI and RP) who are experienced in dNBI and pCLE readings. Before entering into the study, they have experienced in reviewing the images obtained by dNBI and pCLE and published the related results elsewhere.
  • During the study period, all 26 patients underwent the procedure under conscious sedation with intravenous midazolam and meperidine. Ten milligrams of hyoscine was given before the procedure to decrease intestinal peristalsis. At the beginning of the procedure, the first endoscopist (BI) used an end-viewing HWE attached with an endoscopic cap to examine the 1st and 2nd part of duodenum. The cap was used to facilitate a proper enface view of the ampulla and surrounding area. All applicable ampullary and non-ampullary (duodenal) polyps that larger than 1 millimeter would be recruited in this study. Then dNBI mode was switched on for a real-time diagnosis by the first endoscopist (BI). Subsequently, the second endoscopist (RP) who blinded to the NBI reading would be called from another room to perform pCLE examination. Two and a half milliliters of 10% fluorescein (Novartis Pharmaceutical Corporation, Bangkok, Thailand) was injected during pCLE evaluation. When there were more than one non-ampulary lesions, the first endoscopist only navigated the lesions to study under pCLE to the second endoscopist without telling the result of dNBI reading. Then, the matched polypectomy or biopsy was performed by the second endoscopist. The duration of the entire procedure and all complications related to the procedures were recorded.

Histological assessment - All polypectomy and biopsy specimens were immersed in formalin and sent for histological examination. The specimens were stained with hematoxylin and eosin (H&E) and reviewed by an experienced GI pathologist (NW) blinded to the endoscopic diagnosis. The definite diagnosis was based on the Vienna classification for differentiation between adenoma and non-adenoma.

Statistical Analysis

-By using histology as the gold standard, the diagnostic values of dNBI and pCLE for ampullary and non-ampullary polyp interpretation were assessed for sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy. According to PIVI recommendation for colonic adenoma diagnosis20, we used the 90% NPV readings as our cut off. For numerical variables, the results were expressed as a mean ± SD, whereas other quantitative variables are expressed as percentages. SPSS version 17.0 (SPSS (Thailand) Co., Ltd., Bangkok, Thailand) for Windows systems was used for statistical analysis.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnostic Values of Dual Focus Narrow Band Imaging and Probe-based Confocal Laser Endomicroscopy in FAP Related Duodenal Adenoma
Study Start Date : December 2012
Actual Primary Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: Endoscopy
All patients underwent the same endoscopy.
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.
Other Names:
  • White light endoscopy
  • dual focus NBI endoscopy
  • probe-based confocal laser endomicroscopy
  • biopsy




Primary Outcome Measures :
  1. duodenal adenoma diagnosis [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162173


Locations
Layout table for location information
Thailand
King Chulalongkorn Memorial Hospital
Patumwan, Bangkok, Thailand, 10330
Sponsors and Collaborators
King Chulalongkorn Memorial Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Rapat Pittayanon, MD, Doctor, King Chulalongkorn Memorial Hospital
ClinicalTrials.gov Identifier: NCT02162173     History of Changes
Other Study ID Numbers: RP007
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: June 12, 2014
Last Verified: June 2014

Keywords provided by Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital:
Familial adenomatous polyposis syndrome
Non-ampullary polyp
Ampullary polyp
Narrow band imaging endoscopy
Confocal laser endomicroscopy

Additional relevant MeSH terms:
Layout table for MeSH terms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms