Comparison of Helicobacter pylori Eradication plus Rebamipide combination therapy with proton pump inhibitor(PPI) alone in the treatment of endoscopic submucosal dissection(ESD) induced ulcers in H.pylori positive eary gastric cancer: Prospective Randomized Pilot Syudy

Comparison of Helicobacter pylori Eradication plus Rebamipide combination therapy with proton pump inhibitor(PPI) alone in the treatment of endoscopic submucosal dissection(ESD) induced ulcers in H.pylori positive eary gastric cancer: Prospective Randomized Pilot Syudy - Helicobacter pylori Eradication plus Rebamipide promotes gastric ulcer healing after Endoscopic Submucosal Dissection(ESD): Prospective Randomized Pilot Syudy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003181

Enrollment

120

Registered

2010-02-14

Start date

2010-02-01

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 eary gastric cancer

Interventions

Patients in the treatment group receive H.pylori eradication therapy(Omeprazole 40 mg/day, clarithromycin 800 mg/day, amoxicillin 1500 mg/day) for 7 days and then rebamipide (300 mg/day) for 7 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)The patient provided written informed consents to participate in this study. 2)H.pylori positive patient 3)The lesion is to be resected en bloc by ESD. 4)The invasion depth of carcinoma is diagnosed as mucosa endoscopically. 5)It is onset and one-shot(in principle) gastric cancer. 6)The patient without therapeutic medical history for other organ carcinoma. 7)Age is equal to or less than 75 years old more than 20 years old. 8)Sexuality no object.

Exclusion criteria

Exclusion criteria: 1)The patient with past H.pylori eradication treatment 2)The patient who coexists for active gastroduodenal ulcer 3)Upper gastrointestinal tract ablative operation and the patient with medical history of vagotomy 4)The patient who does not become a subject of medical treatment for perforation/pyloric stenosis, a massive bleeding case. 5)The patient who could not interrupt the antiplatelet agent or anticoagulant temporarily for ESD therapy. 6)The patient with medical history of shock by amoxicillin. 7)The patient with glandular infection. 8)The patient with anaphylactic medical history for penicillin antimicrobial agent, clarithromycin, a proton pump inhibitor and rebamipide. 9)The patient who is administrated drug considered to be contraindication of clarithromycin(terfenadine, cisapride, pimoside). 10)The patient with grave complication(respiratory tract disease, kidney disease, treatment by use of insulin or diabetes mellitus inadequate control) and a hindrance for examination enforcement. 11)Inadequate to entry judged by investigators.

Design outcomes

Primary

Measure	Time frame
Endoscopic evaluations:The primary endopoint is the ulcer healing(S1, S2) at 8 weeks after ESD.	—

Secondary

Measure	Time frame
Endoscopic evaluations:ulcer healing rate Symptom Incidence of asynchronous multiple cancer Safety	—

Countries

Japan

Contacts

Public ContactEiji Umegaki

Osaka Medical College Second Department of Internal Medicine

in2038@poh.osaka-med.ac.jp072-683-1221

Outcome results

None listed

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