Grading Atrophic Gastritis by Confocal Laser Endomicroscopy Probe (p-CLE)

NCT02351154 | Completed DMC

• 1 other identifier: IECED 01-08-2014
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrophic Gastritis

Outcome Measures

Primary Outcomes (1)

• Gastric crypt diameters

  to determine the area of the gastric crypt measured by the elliptic area formula (A = π.d1.d2)

  3 months

Secondary Outcomes (1)

• Gastric inter-crypt diameters

  3 months

Study Arms (1)

Atrophic gastritis

OTHER

gastric glands (crypts) with atrophic gastritis were measured using the Cellvizio Viewer software

Other: Cellvizio Viewer software

Interventions

Cellvizio Viewer software OTHER

permets to perform analysis of diameters in micrometers

Atrophic gastritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• dyspepsia \>12 months
• age ≥18, no history of UE evaluation
• GA at histopathology
• acceptance to participate.

You may not qualify if:

• use of proton pump inhibitors
• antibiotics or NSAID´s
• gastric cancer
• gastric surgery
• pregnancy
• contraindication to fluorescein.

Sponsors & Collaborators

• Instituto Ecuatoriano de Enfermedades Digestivas: lead

Study Sites (1)

Instituto Ecuatoriano de Enfermedades Digestivas

Guayaquil, Guayas, 1301266, Ecuador

Location

Related Publications (3)

• 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.

  PMID: 21049554 RESULT

• 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.

  PMID: 18440377 RESULT

• 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.

  PMID: 8827022 RESULT

MeSH Terms

Conditions

Gastritis, Atrophic

Condition Hierarchy (Ancestors)

Gastritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Officials

• Carlos Robles-Medranda, MD

  Instituto Ecuatoriano de Enfermedades Digestivas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: January 30, 2015
• Study Start: September 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 30, 2015

Record last verified: 2015-01

Locations

EC (1)