Trial profile: pilot study of the multicentre randomised trial of H. pylori eradication and pepsinogen testing for prevention of gastric cancer mortality (the GISTAR Pilot study)

Microb Health Dis 2019; 1: e165
DOI: 10.26355/mhd_201912_165

  Topic: Helicobacter pylori     Category:

Abstract

Purpose: The GISTAR Pilot study is part of a large multi-centre randomised trial conducted in Latvia with the main aim to evaluate preventive strategies to decrease mortality from gastric cancer in high-risk areas, especially in the Baltic States and Eastern Europe.

Participants: A total of 3,447 apparently healthy, asymptomatic participants (40-64 y/o) were recruited between 2013 and 2015 for the GISTAR pilot study. Participants were interviewed for socio-economic status, lifestyle, environmental and occupational exposures, medical history, family history of diseases, and dietary habits. Participants were randomly assigned to either Intervention (n=1,724) or Control (n=1,723) group. The intervention included H. pylori eradication of those positives and endoscopic examinations of those whose levels of pepsinogens and gastrin-17 were altered. Participants in the Control group received routine care. All the trial participants are followed up at least for 15 years.

Findings to date: The majority of the participants were Latvian, reported to have a professional training or higher level of education and to be either overweight or obese. Around 26% of the participants were current smokers. The main risk factors for H. pylori positivity were having a Russian nationality, heavy drinking, and spicy food consumption while higher income and consumption of food or drink at hot temperature were associated with the absence of the infection.

Future plans: The GISTAR Pilot study investigates a wide range of epidemiological questions related to gastric cancer and its precursors in an Eastern European country, where the burden of this disease remains high, but epidemiological data to develop a preventive strategy are limited. A series of publications on gastric cancer aetiology and prevention using the Pilot study data are under preparation. GISTAR will add to the current evidence whether H. pylori eradication and endoscopic examination of those with serological evidence of atrophic gastritis would reduce the gastric cancer burden in high-risk areas in Europe.

To cite this article

Trial profile: pilot study of the multicentre randomised trial of H. pylori eradication and pepsinogen testing for prevention of gastric cancer mortality (the GISTAR Pilot study)

Microb Health Dis 2019; 1: e165
DOI: 10.26355/mhd_201912_165

Publication History

Submission date: 07 Nov 2019

Revised on: 11 Nov 2019

Accepted on: 12 Nov 2019

Published online: 13 Dec 2019