Table 4.
Randomized, Controlled Trials for the Screen-and-Treat Strategy
| Study | GISTAR Study | Taiwan | Helicobacter pylori Screening Study |
|---|---|---|---|
| Trial No. | NCT02047994 | NCT01741363 | ISRCTN71557037 |
| Publication | Protocol (Leja et al., 2017)65 | Baseline results (Lee et al., 2021)66 | Protocol67 |
| Country | Latvia/Russia/Belarus/Ukraine | Taiwan | UK |
| Age standardized incidence, per 100,000 | Lavita Men: 18.6 Women: 7.8 |
Men: 10.6 Women: 6.6 |
Men: 5.4 Women: 2.7 |
| Subjects | Healthy population | Healthy population | Healthy population |
| Intervention | |||
| Serological testing | H. pylori antibody + PG | H. pylori stool antigen + FIT | H. pylori testing (method unclear) |
| Treatment regime (first line) | Esomeprazole 40 mg Clarithromycin 500 mg Amoxicillin 1,000 mg (twice/day for 10 days) |
Days 1–5 Esomeprazole 40 mg once/day Clarithromycin 500 mg twice/day Days 6–10 Esomeprazole 40 mg once/day Clarithromycin 500 mg twice/day Metronidazole 500 mg twice/day |
Oral metronidazole, clarithromycin and lansoprazole (dose and days were unclear) |
| Comparator | Usual care (no screening) | Usual care (no screening + FIT) | Usual care (no screening) |
| Target age, yr | 40–64 | 50–69 | Men: 35–69 Women: 45–69 |
| Number invited | 30,000 | Intervention arm 63,508 Control arm 88,995 |
56,000 |
| Recruitments | On-going | Completed | Completed |
| Follow-up, yr | 15 | 10 | 15 |
| Primary outcome | Gastric cancer mortality | Gastric cancer incidence | Gastric cancer incidence/gastric cancer mortality |
PG, pepsinogen; FIT, fecal immunological testing.