Dual Focus NBI and pCLE in FAP Related Duodenal Adenoma

study id #: NCT02162173

condition: Complication of Diagnostic Procedure , Adverse Effect of Diagnostic Agents, Subsequent Encounter

status: completed

intervention: Procedure: Endoscopy

start date: December 2012

estimated completion: November 2013

last updated: June 12, 2014

phase of development: Not Available

size / enrollment: 26

study design:
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

study 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.

primary outcomes:

• Duodenal adenoma diagnosis [ Time Frame:1 year ] [ Designated as safety issue: Yes ]

inclusion criteria:

exclusion criteria:
-Evidence of coagulopathy (INR >= 1.5 and/or platelet < 80,000) -Other bleeding tendency precluding biopsy -Pregnancy -Allergy to fluorescein sodium

sponsor: King Chulalongkorn Memorial Hospital

trial center locations: Thailand