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Abstract
Introduction Population-based eradication of Helicobacter pylori has been suggested to be cost-effective and is recommended by international guidelines. However, the potential adverse effects of widespread antibiotic use that this would entail have not been sufficiently studied. An alternative way to decrease gastric cancer mortality is by non-invasive search for precancerous lesions, in particular gastric atrophy; pepsinogen tests are the best currently available alternative. The primary objective of GISTAR is to determine whether H pylori eradication combined with pepsinogen testing reduces mortality from gastric cancer among 40–64-year-old individuals. The secondary objectives include evaluation of H pylori eradication effectiveness in gastric cancer prevention in patients with precancerous lesions and evaluation of the potential adverse events, including effects on microbiome.
Methods and analysis Individuals are recruited from general population (50% men) in areas with high gastric cancer risk in Europe and undergo detailed lifestyle and medical history questionnaire before being randomly allocated to intervention or control groups. The intervention group undergoes H pylori testing and is offered eradication therapy if positive; in addition, pepsinogen levels are detected in plasma and those with decreased levels are referred for upper endoscopy. All participants are offered faecal occult blood testing as an incentive for study participation. Effectiveness of eradication and the spectrum of adverse events are evaluated in study subpopulations. A 35% difference in gastric cancer mortality between the groups is expected to be detectable at 90% power after 15 years if 30 000 individuals are recruited. Biological materials are biobanked for the main and ancillary studies. The study procedure and assumptions will be tested during the pilot phase.
Ethics and dissemination The study was approved by the respective ethics committees. An independent Data Safety and Monitoring Board has been established. The findings will be published in peer-reviewed journals and presented at scientific meetings.
Trial registration number NCT02047994
- Gastric Cancer
- Prevention
- H. Pylori
- Eradication
- Pepsinogen
- Randomised Study
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Footnotes
Contributors ML, JYP, MP and RH have been involved in initial design of the protocol. JYP, SP, ILK, SI, IK, DR, AK, DS, ID and VF committed to developing particular specialised parts of the protocol. RM, IP and RH committed to adjusted version of the initial protocol and MP, JYP and RM to the statistical evaluations and study sample size t estimates. ML, JYP and RM wrote the manuscript. All coauthors have participated in improvements to the manuscript and acceptance of it.
Funding The study has been supported in part by various funding sources in the University of Latvia; this includes the funding schemes from the European Regional Development Fund (ERDF) and the National Program for Research in Latvia: Biomedicine 2014–2017. The protocol development was supported in part by the project of the European Social Fund No. 009/0220/1DP/1.1.1.2.0/09/APIA/VIAA/016 ‘Multidisciplinary research group for early cancer detection and cancer prevention’.
Competing interests ML is a partner in institutions involved in realisation of the project—Digestive Diseases Centre GASTRO and Academic Histology laboratory. ILK and SI are employees of Academic Histology Laboratory, IK—of Digestive Diseases Centre GASTRO. Otherwise, the authors declare that they have no competing interests.
Ethics approval IARC, Central Medical Ethics Committee of Latvia, Ethics Committee of Riga East University Hospital Support Foundation.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Data from the pilot study are currently being analysed to be presented in further publications. These data are available to the principal investigators, study statistician and Data Management Board members. The results will be disseminated during international and national conferences and congresses, published in peer-reviewed papers.