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Non-inferiority study of P-CAB for Cure of Ulcer Resected by ESD

Non-inferiority study of P-CAB for Cure of Ulcer Resected by ESD - P-CURE STUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000031564
Enrollment
300
Registered
2018-03-05
Start date
2018-03-05
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 or gastric adenoma

Interventions

Included subjects take Bonoprazan 20mg per day for 21 days. Included subjects take Bonoprazan 20mg per day for 56 days.

Sponsors

Keio University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients aged 20-85 undergoing gastric ESD for early gastric cancer or gastric adenoma.

Exclusion criteria

Exclusion criteria: 1) Patients with past history of surgery for upper GI tract. 2) Patients with eGFR<30 or on hemodialysis. 3) Patients with uncompensated liver cirrhosis. 4) Patients with severe bleeding tendency. 5) Patients taking systemic NSAIDs or steroid. 6) Patients taking anti-platelet or coagulant drugs. 7) Patients taking PPI or P-CAB continuously at the time of registry. 8) Patients with perforation during ESD. 9) Patients not fulfilling curative criteria by ESD. 10) Patients taking Atazanavir or Rirupibirin. 11) Patients who attending physicians consider to be inappropriate due to other reasons mentioned above

Design outcomes

Primary

MeasureTime frame
Proportion of complete closure of post ESD ulcer at 24 weeks after gastric ESD.

Secondary

MeasureTime frame
1) Proportion of bleeding within 3 weeks after gastric ESD. 2) Proportion of bleeding more than 3 weeks after gastric ESD. 3) Proportion of perforation within 3 weeks after gastric ESD. 4) Proportion of perforation more than 3 weeks after gastric ESD. 5) Proportion of complete closure of post ESD ulcer at 8 weeks after gastric ESD. 6) Status of post ESD ulcer (evaluated based on Sakita Miwa classification) at 8 and 24 weeks after ESD. 7) Medical care cost.

Countries

Japan

Contacts

Public ContactMotohiko Kato

Keio University School of Medicine Division of Gastroenterology and Hepatology, Department of Internal Medicine

moto28hiko@icloud.com03-5363-3437

Outcome results

None listed

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