Grading Atrophic Gastritis by Confocal Laser Endomicroscopy Probe (p-CLE)
NCT ID: NCT02351154
Last Updated: 2015-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2014-09-30
2014-11-30
Brief Summary
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Detailed Description
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During UE 5 biopsy sites were performed in accordance to update Sydney system first using p-CLE and them by biopsy forceps from the same site (2 from the lesser and greater curvature of the antrum about 2-3 cm near the pylorus, 2 from the middle portion of the lesser and greater curvatures of the corpus about 8 cm from the cardia, and 1 from the angulus). p-CLE images were recorded as video frames and pictures during in vivo microscopy analysis.
For histopathology all specimens were fixed in 10% formalin. An experienced histopathologist analyzed the histological features of each sample with hematoxylin and eosin staining and made the diagnosis according to the updated Sydney classification.
At p-CLE normal crypt was defined by using the classification of Wang et al. After histopathology confirm GA, crypts were analyzed using the CV software that is a post-procedure tool that could be installed in computers, working as a laboratory data analyzer. This software permits to measure diameters of the microscopy findings in an escalade model in micrometers, using different colors lines and giving their results in a table that could be exported as excel table for analysis of the results The crypts diameters were measuring to determine the area by using the elliptic area formula (A = π.d1.d2). The inter-crypt space was also measured and defined as the mean of each measured distance between the studied crypt and it's adjacent.
The cutoff value between mild, moderate and severe GA, crypts area was classified across tertiles, expressing its distribution using a box-spot graphic. For relationship between crypt area (CA) and inter-crypt space, quadratic polynomial regression was used. Data was processed using IBM® SPSS® Statistics.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Atrophic gastritis
gastric glands (crypts) with atrophic gastritis were measured using the Cellvizio Viewer software
Cellvizio Viewer software
permets to perform analysis of diameters in micrometers
Interventions
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Cellvizio Viewer software
permets to perform analysis of diameters in micrometers
Eligibility Criteria
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Inclusion Criteria
* age ≥18, no history of UE evaluation
* GA at histopathology
* acceptance to participate.
Exclusion Criteria
* antibiotics or NSAID´s
* gastric cancer
* gastric surgery
* pregnancy
* contraindication to fluorescein.
18 Years
ALL
No
Sponsors
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Instituto Ecuatoriano de Enfermedades Digestivas
OTHER
Responsible Party
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Principal Investigators
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Carlos Robles-Medranda, MD
Role: PRINCIPAL_INVESTIGATOR
Instituto Ecuatoriano de Enfermedades Digestivas
Locations
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Instituto Ecuatoriano de Enfermedades Digestivas
Guayaquil, Guayas, Ecuador
Countries
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References
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Wang P, Ji R, Yu T, Zuo XL, Zhou CJ, Li CQ, Li Z, Li YQ. Classification of histological severity of Helicobacter pylori-associated gastritis by confocal laser endomicroscopy. World J Gastroenterol. 2010 Nov 7;16(41):5203-10. doi: 10.3748/wjg.v16.i41.5203.
Zhang JN, Li YQ, Zhao YA, Yu T, Zhang JP, Guo YT, Liu H. Classification of gastric pit patterns by confocal endomicroscopy. Gastrointest Endosc. 2008 May;67(6):843-53. doi: 10.1016/j.gie.2008.01.036.
Dixon MF, Genta RM, Yardley JH, Correa P. Classification and grading of gastritis. The updated Sydney System. International Workshop on the Histopathology of Gastritis, Houston 1994. Am J Surg Pathol. 1996 Oct;20(10):1161-81. doi: 10.1097/00000478-199610000-00001.
Other Identifiers
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IECED 01-08-2014
Identifier Type: -
Identifier Source: org_study_id