Complication of Diagnostic Procedure Clinical Trial
Official title:
Diagnostic Values of Dual Focus Narrow Band Imaging and Probe-based Confocal Laser Endomicroscopy in FAP Related Duodenal Adenoma
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%
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01563198 -
Reduction of Claustrophobia and Patient Motion After Training of MRI Personnel in Comfort TalkTM
|
N/A | |
| Completed |
NCT02427737 -
Comfort Talk and Economic Outcomes in MRI
|
N/A |