Randomised comparison study: eradication therapy for Helicobacter pylori with or without ecabet sodium after endoscopic submucosal dissection (ESD) of early gastric cancer

Randomised comparison study: eradication therapy for Helicobacter pylori with or without ecabet sodium after endoscopic submucosal dissection (ESD) of early gastric cancer - Quadruple eradication therapy with ecabet sodium of early gastric cancer after ESD.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007735

Enrollment

330

Registered

2012-04-12

Start date

2012-02-01

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

H.pylori positive early gastric cancer patient who underwent an ESD.

Interventions

Control group: patients receive H.pylori eradication therapy (omeprazole 20 mg, amoxicillin 750mg, clarithromycin 200mg) twice a day for 1 week and then omeprazole (20mg once a day) for 4 weeks. Treat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The function of main organ(hearrt, lung, liver, kidney)is kept and the clinical inspection levels are within the following rules. 1.WBC:>=3000/mm3, <=12000/mm3 2.Hb:>=9.0g/dL 3.PLT:>=100,000/mm3 4.AST, ALT:<=100IU/L 5.T-Bil:<=2.0mg/dL 6.Serum CRE:<=1.5mg/dL The sympton is slight even if complicated with other disease, and there is not problem to receive eradication therapy. The patient provided written informed consents to participate in this study.

Exclusion criteria

Exclusion criteria: 1 Patients with past H.pylori eradication therapy. 2. Patients with suspected gastrointestinal stenosis and diagnosed gastrointestinal stenosis. 3. Patients with a history of upper gastrointestinal tract ablative operation or the vagotomy. 4. Patients with the active overlap cancer except the gastric cancer. 5. Patients with severe liver, renal, cardiac or hematopoietic dysfunction. 6. Patients with hypersensitivity to ecabet sodium. 7. Pregnant or lactating women or women who intended to become pregnant during the study period. 8. Patients with a history of allergy to omeprazole, amoxicilline, clarithromycin, or penicilline. 9. Patients receiving atazanavir sulfate, pimozide, ergotamine component preparation, tadalafil(adcirca). 10. Patients with mononucleosis. 11. Inadequate to entry judged by investigator.

Design outcomes

Primary

Measure	Time frame
Eradication rate: 8 weeks after eradication therapy (12 weeks after ESD treatment)	—

Secondary

Measure	Time frame
Ulcer healing : 8 weeks after ESD treatment	—

Countries

Japan

Contacts

Public ContactTanabe Satoshi

Kitasato University School of Medicine Department of Gastroenterology

s-tanabe@kitasato-u.ac.jp042-748-9111

Outcome results

None listed

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