Randomized controlled trial comparing gastric cancer screening by gastrointestinal X-ray with serology for Helicobacter pylori and pepsinogens followed by gastrointestinal endoscopy

Abstract

Background Based on the results of several case-control and cohort studies gastrointestinal X-ray (GI X-ray) has been recommended for use in the nationwide screening program for gastric cancer.. Although this was the only effective screening program when almost all of the Japanese population were Helicobacter pylori (H. pylori) positive, there has been concern whether an alternative effective screening system should be established for the future H. pylori-negative generation. We therefore conducted the first randomized controlled trial (RCT) comparing GI X-ray and gastrointestinal endoscopy (GIE) scheduled according to results of serological testing (ST); this was done to determine the potential for an alternative screening method. Methods Subjects who fulfilled the inclusion criteria were residents between the ages of 30 and 74 and who were able to receive gastric cancer screening in the Yurihonjo area. Participants were assigned to the GI X-ray group or the GIE-ST group by computer randomization. Subjects in each group were further subdivided into 4 categories according to their different risks for gastric cancer. The feasibility of stratified randomization was serologically assessed and detection rates of gastric cancer at entry by the different screening methods were also compared. Results Of the 2,962 subjects invited, 1,206 individuals (41 percent) were included in the first stage of this stratified RCT, and 604 and 602 individuals were assigned to the GI X-ray group and the GIE-ST group, respectively. There were no statistically significant differences in sex, age, height, body weight, smoking, alcohol intake and family history of cancer between the 2 groups. During ST the GI X-ray group showed a distribution that was not statistically different from that of the GIE-ST group. Although 3 cases of gastric cancer were detected in the GIE-ST group, there was no statistically significant difference between the 2 groups. One complication found was barium aspiration during the examination in the X-ray group. Conclusion We confirmed that baseline demographic features of the 2 groups were well balanced. We are now organizing the first RCT to compare the existing screening method and the alternative method (Clinical trial registration number: UMIN000005962).Electronic supplementary material The online version of this article

Gastric Cancer Screening by Combined Assay for Serum Anti-<b><i>Helicobacter pylori</i></b> IgG Antibody and Serum Pepsinogen Levels - The ABC Method

“…It cannot be completely denied that the participants in the ABC method received harmful effects associated with low quality. To make the ABC method more practical for communities, a large epidemiological study is desirable [26] .…”

The administrative project of Helicobacter pylori infection screening among junior high school students in an area of Japan with a high incidence of gastric cancer

“…Therefore, it is important to determine the current status of H. pylori infection in children to predict the future incidence of H. pylori-related diseases, including gastric cancer. which could be incorporated into a prevention strategy [9,10]. However, the Electronic supplementary material The online version of this article (doi:10.1007/s10120-017-0688-7) contains supplementary material, which is available to authorized users.…”

Chinese consensus on chronic gastritis (2017, Shanghai)

“…PG I ≤70 g/L and PG I/II ratio ≤3.0 are used as the diagnostic thresholds for atrophic gastritis. In Europe and Japan, this threshold is widely used for the screening of high‐risk groups for gastric cancer . In the high‐risk areas of gastric cancer in China, the standard of PG I ≤70 g/L and PG I/II ratio ≤7.0 is used for screening, but there is currently a lack of large follow‐up data for verification.…”

“…In Europe and Japan, this threshold is widely used for the screening of high-risk groups for gastric cancer. 159 In the highrisk areas of gastric cancer in China, the standard of PG I ≤70 g/L and PG I/II ratio ≤7.0 is used for screening, 160 but there is currently a lack of large follow-up data for verification. Several studies [161][162][163] have demonstrated that serum PG test contributes to risk stratification in high-risk groups for gastric cancer.…”