The multicenter randomized controlled trial on the effect of Helicobacter pylori eradication for endoscopic gastric submucosal dissection (ESD) after artificial ulcer healing

The multicenter randomized controlled trial on the effect of Helicobacter pylori eradication for endoscopic gastric submucosal dissection (ESD) after artificial ulcer healing - The multicenter randomized controlled trial on the effect of HP eradication in healing of artificial ulcer after ESD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015927

Enrollment

130

Registered

2015-01-01

Start date

2015-01-01

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

Patients have early gastric cancer endoscopic therapeutic indications lesions and adaptation expanding lesions, are Helicobacter pylori infection including the adenoma

Interventions

do HP eradication after ESD donot performed HP eradication after ESD

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who agreed to participate in this study by the description document. 20 years of age and older adults. Patients Helicobacter pylori infection has been confirmed. Patient is determined to be the resected lesion in ESD. Patients adenoma or depth of invasion has been diagnosed with intramucosal cancer. Performance status is 0, 1, 2 patients.

Exclusion criteria

Exclusion criteria: Patients by narrowing and deformation of the upper gastrointestinal tract, drug administration and the endoscope insertion can be considered difficult. Patients with complications of active malignancy or other serious systemic. Patients with active ulcer. Serious complications, patients with (heart failure, renal failure than (creatinine clearance 60 (mL / min)), liver failure, respiratory failure). Patients on dialysis. Patients with a history of allergy to the study drug. Patients during pregnancy and lactation. Patients with a history of radiation therapy to the upper abdomen. Esophageal lesions, and patients who are scheduled for endoscopic therapy at the same time against duodenal lesions. Patients with registration history in this study. Patients who did not consent to participate in this clinical study. Others, patients who test responsibility (sharing) doctor has determined to be inappropriate as a subject.

Design outcomes

Primary

Measure	Time frame
Artificial ulcer healing rate after ESD enforcement 56 days	—

Secondary

Measure	Time frame
Reduction ratio of ESD after artificial ulcer, adverse events incidence	—

Countries

Japan

Contacts

Public ContactAkihiro Shimozato

Aichi Medical University Gastroenterology

shimozato.akihiro.274@mail.aichi-med-u.ac.jp0561-62-1508

Outcome results

None listed

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