Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02351154
Other study ID # IECED 01-08-2014
Secondary ID
Status Completed
Phase N/A
First received January 27, 2015
Last updated January 29, 2015
Start date September 2014
Est. completion date November 2014

Study information

Verified date January 2015
Source Instituto Ecuatoriano de Enfermedades Digestivas
Contact n/a
Is FDA regulated No
Health authority Ecuador: Public Health Ministry
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date November 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Other:
Cellvizio Viewer software
permets to perform analysis of diameters in micrometers

Locations

Country Name City State
Ecuador Instituto Ecuatoriano de Enfermedades Digestivas Guayaquil Guayas

Sponsors (1)

Lead Sponsor Collaborator
Instituto Ecuatoriano de Enfermedades Digestivas

Country where clinical trial is conducted

Ecuador, 

References & Publications (3)

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. Review. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Gastric crypt diameters to determine the area of the gastric crypt measured by the elliptic area formula (A = p.d1.d2) 3 months Yes
Secondary Gastric inter-crypt diameters measuring the distance of the gastric inter-crypt space. 3 months Yes
See also
  Status Clinical Trial Phase
Completed NCT02724280 - Linked Color Imaging to Differentiate H. Pylori Associated Gastritis and Gastric Atrophy N/A
Completed NCT02597517 - New Technology to Differentiate Normal Gastric Mucosa From Helicobacter Pylori Associated Gastritis and Gastric Atrophy N/A
Recruiting NCT05209633 - Efficacy and Safety of Using Granules Dendrobii for the Treatment of Chronic Atrophic Gastritis Phase 2
Recruiting NCT04022109 - Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach
Recruiting NCT05053945 - Helicobacter Pylori, Atrophic Gastritis and Intestinal Metaplasia Registry and Prospective Study
Recruiting NCT02047994 - Multicentric Randomized Study of H. Pylori Eradication and Pepsinogen Testing for Prevention of Gastric Cancer Mortality Phase 4
Completed NCT01896310 - New Classification of Stomach Using Probe-based Confocal Laser Endomicroscopy N/A
Recruiting NCT05916014 - AI-assisted White Light Endoscopy to Identify the Kimura-Takemoto Classification of Atrophic Gastritis
Completed NCT05969444 - Endoscopic Surveillance on a High-risk Population for Gastric Cancer in Latin America: The ECHOS Cohort Study.
Recruiting NCT04191551 - The GAstric Precancerous Conditions Study
Enrolling by invitation NCT03228095 - Volatiles in Breath and Headspace Analysis - Diagnostic Markers
Recruiting NCT02833363 - Difference of Gastric Microbiota in the Process of Correa's Model. Phase 4
Enrolling by invitation NCT05021029 - A Study of Pre-Malignant Gastric Conditions
Recruiting NCT04085211 - Image-Enhanced Endoscopy in the Gastrointestinal Tract
Completed NCT02332213 - Volatile Markers in Digestive Cancer
Recruiting NCT04613570 - SUrveillance of PREMalignant Stomach - Individualized Endoscopic Follow-up N/A
Recruiting NCT06203327 - Atrophic Gastritis Predicts the Risk of Gastric Cancer
Active, not recruiting NCT05631015 - Artificial Intelligence for Determination of Gastroscopy Surveillance Intervals
Not yet recruiting NCT04251403 - Novel Approach to Surveillance of Gastric Lesions Early Phase 1
Completed NCT02691637 - Effect of H. Pylori Eradication on the Reversibility of Atrophic Gastritis and Intestinal Metaplasia in Korean Patients