Grading Atrophic Gastritis by Confocal Laser Endomicroscopy Probe (p-CLE)
Primary Purpose
Atrophic Gastritis
Status
Completed
Phase
Not Applicable
Locations
Ecuador
Study Type
Interventional
Intervention
Cellvizio Viewer software
Sponsored by
About this trial
This is an interventional diagnostic trial for Atrophic Gastritis
Eligibility Criteria
Inclusion Criteria:
- dyspepsia >12 months
- age ≥18, no history of UE evaluation
- GA at histopathology
- acceptance to participate.
Exclusion Criteria:
- use of proton pump inhibitors
- antibiotics or NSAID´s
- gastric cancer
- gastric surgery
- pregnancy
- contraindication to fluorescein.
Sites / Locations
- Instituto Ecuatoriano de Enfermedades Digestivas
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Atrophic gastritis
Arm Description
gastric glands (crypts) with atrophic gastritis were measured using the Cellvizio Viewer software
Outcomes
Primary Outcome Measures
Gastric crypt diameters
to determine the area of the gastric crypt measured by the elliptic area formula (A = π.d1.d2)
Secondary Outcome Measures
Gastric inter-crypt diameters
measuring the distance of the gastric inter-crypt space.
Full Information
NCT ID
NCT02351154
First Posted
January 27, 2015
Last Updated
January 29, 2015
Sponsor
Instituto Ecuatoriano de Enfermedades Digestivas
1. Study Identification
Unique Protocol Identification Number
NCT02351154
Brief Title
Grading Atrophic Gastritis by Confocal Laser Endomicroscopy Probe (p-CLE)
Official Title
Grading Atrophic Gastritis by a New Quantitative Method Using Confocal Laser Endomicroscopy Probe (p-CLE): First Results of a Prospective Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Ecuatoriano de Enfermedades Digestivas
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Atrophic gastritis (AG) is a chronic disease, associated to gastric adenocarcinoma moreover if severity AG is present. Sydney system classified AG as mild, moderate and severe, but with moderate interobserver agreement, due to this system is based in a visual analogic scale (qualitative analysis). Confocal endomicroscopy showed an accuracy of 98% for diagnosis gastric diseases, but when grading AG still remains a qualitative measure. Recently, a new software called "Cellvizio® Viewer" (CV) permits to measure in micrometers (µm) the structures observed after confocal laser endomicroscopy probe studies. Based on the hypothesis that AG severity is correlated with crypts size diminution, the aim of this study is to determine a quantitative way to classify the severity of AG measuring the crypt area and inter-crypt spaces in patients with AG.
Detailed Description
Consecutive patients that underwent to upper endoscopy (UE) evaluation were included in this study. All subjects went to UE according to standard procedure, under propofol sedation, and using a high definition endoscope with a working channel of 2.8 mm After gastric mucosa inspection using endoscopy, in vivo microscopy analysis at x1000 magnification was done using confocal laser endomicroscopy probe (p-CLE) in all patients.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophic Gastritis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atrophic gastritis
Arm Type
Other
Arm Description
gastric glands (crypts) with atrophic gastritis were measured using the Cellvizio Viewer software
Intervention Type
Other
Intervention Name(s)
Cellvizio Viewer software
Intervention Description
permets to perform analysis of diameters in micrometers
Primary Outcome Measure Information:
Title
Gastric crypt diameters
Description
to determine the area of the gastric crypt measured by the elliptic area formula (A = π.d1.d2)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Gastric inter-crypt diameters
Description
measuring the distance of the gastric inter-crypt space.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
dyspepsia >12 months
age ≥18, no history of UE evaluation
GA at histopathology
acceptance to participate.
Exclusion Criteria:
use of proton pump inhibitors
antibiotics or NSAID´s
gastric cancer
gastric surgery
pregnancy
contraindication to fluorescein.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Robles-Medranda, MD
Organizational Affiliation
Instituto Ecuatoriano de Enfermedades Digestivas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Ecuatoriano de Enfermedades Digestivas
City
Guayaquil
State/Province
Guayas
ZIP/Postal Code
1301266
Country
Ecuador
12. IPD Sharing Statement
Citations:
PubMed Identifier
21049554
Citation
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.
Results Reference
result
PubMed Identifier
18440377
Citation
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.
Results Reference
result
PubMed Identifier
8827022
Citation
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.
Results Reference
result
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Grading Atrophic Gastritis by Confocal Laser Endomicroscopy Probe (p-CLE)
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