A Phase III trial of inhibitory effect of metachronous gastric cancer by Helicobacter pylori eradication for patients after endoscopic submucosal dissection

A Phase III trial of inhibitory effect of metachronous gastric cancer by Helicobacter pylori eradication for patients after endoscopic submucosal dissection - RCT of helicobacter pylori eradication after gastric ESD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018403

Enrollment

1000

Registered

2015-11-01

Start date

2015-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early gastric cancer

Interventions

Patients in eradication group undergo eradication of Helicobacter pylori within 6 months after ESD. Patients in non-eradication group are followed up without eradication of Helicobacter pylori.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) ESD specimen revealed tubular adenocarcinoma histologically and primary cancer 2) curative resection(absolute and expanded criteria) 3) both single and multiple lesions 4) lesions expected not to occur stricture due to ESD scar 5) Helicobacter pylori positive 6) no history of eradication of Helicobacter pylori 7) clinical N0 and M0 8) an age of 60 to 81 years 9) an Eastern Cooperative Oncology Group(ECOG) performance status(PS) of 0 or 1 10) no history of gastrectomy and esophagectomy 11) no prior chemotherapy within 5 years (in case of breast cancer, within 10 years) 12) laboratory data of total bilirubin is less than 2.5mg/dL, serum creatinine less than 2.0mg/dL 13) written informed consent

Exclusion criteria

Exclusion criteria: (1) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ (2) Infectious disease with systemic therapy indicated. (3) Body temperature of 38 or more degrees Celsius. (4) pregnant or breast-feeding women (5) Severe psychiatric disease. (6) Continuous systemic steroid therapy. (7) Unstable angina pectoris, or history of myocardial infarction within six months. (8) Poorly controlled hypertension. (9) Severe respiratory disease requiring continuous oxygen therapy. (10)Penicillin allergy (11) Poorly controlled diabetes mellitus in spite of continuous use of insulin.

Design outcomes

Primary

Measure	Time frame
The proportion of 5 -year cumulative metachronous gastric cancer	—

Secondary

Measure	Time frame
The proportion of 5 -year cumulative metachronous gastric cancer according to pepsinogen levels The proportion of annual cumulative metachronous gastric cancer Overall survival time Disease free survival time The proportion of the incidence of reflux esophagitis The proportion of exacerbation of reflux esophagitis	—

Countries

Japan

Contacts

Public ContactTomoko Kimura

Shizuoka Cancer Center Endoscopy Division

h.ono@scchr.jp055-989-5222

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026