New Technology to Differentiate Normal Gastric Mucosa From Helicobacter Pylori Associated Gastritis and Gastric Atrophy

NCT02597517 | Completed DMC

• 1 other identifier: Sept-1-2015
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopy is a tool that has greatly influenced gastroenterological diagnosis. However, conventional endoscopy is limited to detecting lesions on the basis of gross morphological changes and therefore a certainly diagnosis depends on biopsy sampling of macroscopically obvious endoscopic features, or blind biopsy sampling of normal appearing mucosa with the risk of missed pathology and sampling errors. Gastric cancer is the second most common cause of cancer related death. One of the main roles of upper gastrointestinal endoscopy is to identify gastric cancer at an early stage. The importance of identifying H. pylori infection is because it plays a very important role in gastric carcinogenesis, progressing from chronic gastritis through atrophic gastritis, intestinal metaplasia, dysplasia and finally cancer. The importance of recognition a precancerous gastric lesion is because we can detect most tumors at an early stage and improve the survival. Most studies conclude that it is difficult to diagnose H. pylori related gastritis and gastric atrophy on the basis of endoscopic findings. Histology is therefore currently considered to be the gold standard for detecting H. pylori infection. The reliability of detecting H. pylori infection histologically depends on the site, number, and size of gastric biopsy specimens, as well as on expertise in staining and visualizing the bacteria. Considerable error also occurs in identifying gastric atrophy using blind biopsy sampling, and neither the original nor the revised version of the Sydney system reliably identifies more than half the cases in patients with confirmed gastric atrophy.

Conditions

Gastritis; Helicobacter Pylori Associated Gastritis; Atrophic Gastritis

Keywords

gastritis; chromoendoscopy; magnification; Helicobacter pylori; Atrophic gastritis

Outcome Measures

Primary Outcomes (3)

• Utility OE System™ + Magniview™ in the diagnosis of normal gastric mucosa. Number of patients with type 1 in the Anagnostopoulos GK et al. classification.

  Anagnostopoulos GK et al. classified the gastric body mucosal in four types: type 1, honeycomb-type subepithelial capillary network (SECN) with regular arrangement of collecting venules and regular, round pits. Type 1 pattern for predicting normal gastric mucosa.

  two months

• Utility OE System™ + Magniview™ in the diagnosis of Helicobacter pylori associated gastritis. Number of patients with type 2,3 in the Anagnostopoulos GK et al. classification.

  Anagnostopoulos GK et al. classified the gastric body mucosal in four types: type 2, honeycomb-type SECN with regular, round pits, but loss of collecting venules; type 3, loss of normal SECN and collecting venules, with enlarged white pits surrounded by erythema. Types 2 and 3 patterns for predicting a Helicobacter pylori infection.

  two months

• Utility OE System™ + Magniview™ in the diagnosis of gastric atrophy. Number of patients with type 4 in the Anagnostopoulos GK et al. classification.

  Anagnostopoulos GK et al. classified the gastric body mucosal in four types: type 4, loss of normal SECN and round pits, with irregular arrangement of collecting venules. Type 4 patterns for predicting gastric atrophy.

  two months

Secondary Outcomes (1)

• Measures inter and intra-observer reproducibility in the assessment of the endoscopic patterns detected.

  two months

Study Arms (2)

Intervention group

(Digital chromoendoscopy and magnification) Patients with functional dyspepsia and positive stool antigen test for H pylori in whom gastric body mucosal will be evaluated with digital chromoendoscopy (OE system) and magnification technology in addition to white light

Device: Digital chromoendoscopy and magnification

Control group

(Digital chromoendoscopy and magnification) Patients with functional dyspepsia and negative stool antigen test for H pylori in whom gastric mucosal body will be evaluated with digital chromoendoscopy (OE system) and magnification technology in addition to white light

Device: Digital chromoendoscopy and magnification

Interventions

Digital chromoendoscopy and magnification DEVICE

After the gastric body mucosal evaluation with white light endoscopy, the Optical Enhancement chromoendoscopy and magnification will be used for a more detailed evaluation of the subepithelial capillary network, the collecting venules and mucosal pits

Also known as: OE System (EPK-i7010) and Magniview (EG-2990Zi)

Control group; Intervention group

Eligibility Criteria

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

Study Population

Two groups of functional dyspeptic patients will be selected randomly. Functional dyspepsia will be considered according to the Rome III. Criteria. It will include Epigastric pain Syndrome defined as located pain or burning in the upper abdomen, at least once a week, intermittent, not generalized, not relieved by defecation and without criteria of gall bladder or sphincter of Oddi pathology; and Postprandial distress Syndrome defined as the presence of one or both conditions including nagging feeling of postprandial fullness after normal volume meals, several times a week and early satiety that prevents the completion of a regular meal, several times a week. The criteria must be present in the last three months and have started at least 6 months before diagnosis.

You may qualify if:

• Above 18 years old patients
• Who agree to participate in the study
• Patients with functional dyspeptic symptoms

You may not qualify if:

• Patients, who were receiving nonsteroidal anti-inflammatory drugs, pump inhibitors (PPI) or antibiotics in the last 3 weeks.
• Severe uncontrolled coagulopathy
• Prior history of gastric surgery.
• Pregnancy and lactation

Sponsors & Collaborators

• Instituto Ecuatoriano de Enfermedades Digestivas: lead

Study Sites (1)

Instituto Ecuatoriano de Enfermedades Digestivas, Omnihospital

Guayaquil, Guayas, 090505, Ecuador

Location

Related Publications (8)

• Anagnostopoulos GK, Yao K, Kaye P, Fogden E, Fortun P, Shonde A, Foley S, Sunil S, Atherton JJ, Hawkey C, Ragunath K. High-resolution magnification endoscopy can reliably identify normal gastric mucosa, Helicobacter pylori-associated gastritis, and gastric atrophy. Endoscopy. 2007 Mar;39(3):202-7. doi: 10.1055/s-2006-945056. Epub 2007 Feb 1.

  PMID: 17273960 RESULT

• Correa P. Human gastric carcinogenesis: a multistep and multifactorial process--First American Cancer Society Award Lecture on Cancer Epidemiology and Prevention. Cancer Res. 1992 Dec 15;52(24):6735-40.

  PMID: 1458460 RESULT

• Whiting JL, Sigurdsson A, Rowlands DC, Hallissey MT, Fielding JW. The long term results of endoscopic surveillance of premalignant gastric lesions. Gut. 2002 Mar;50(3):378-81. doi: 10.1136/gut.50.3.378.

  PMID: 11839718 RESULT

• Bah A, Saraga E, Armstrong D, Vouillamoz D, Dorta G, Duroux P, Weber B, Froehlich F, Blum AL, Schnegg JF. Endoscopic features of Helicobacter pylori-related gastritis. Endoscopy. 1995 Oct;27(8):593-6. doi: 10.1055/s-2007-1005764.

  PMID: 8608753 RESULT

• Calabrese C, Di Febo G, Brandi G, Morselli-Labate AM, Areni A, Scialpi C, Biasco G, Miglioli M. Correlation between endoscopic features of gastric antrum, histology and Helicobacter pylori infection in adults. Ital J Gastroenterol Hepatol. 1999 Jun-Jul;31(5):359-65.

  PMID: 10470592 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

• Neumann H, Fujishiro M, Wilcox CM, Monkemuller K. Present and future perspectives of virtual chromoendoscopy with i-scan and optical enhancement technology. Dig Endosc. 2014 Jan;26 Suppl 1:43-51. doi: 10.1111/den.12190. Epub 2013 Oct 23.

  PMID: 24373000 RESULT

• Drossman DA. The functional gastrointestinal disorders and the Rome III process. Gastroenterology. 2006 Apr;130(5):1377-90. doi: 10.1053/j.gastro.2006.03.008. No abstract available.

  PMID: 16678553 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Histological biopsies from gastric mucosal

MeSH Terms

Conditions

Gastritis; Gastritis, Atrophic

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Officials

• Carlos A Robles-Medranda, MD

  Ecuadorian Institute of Digestive Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: November 5, 2015
• Study Start: November 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 3, 2016

Record last verified: 2016-05

Locations

EC (1)