Primary endoscopic hemostasis after EST between balloon tamponade technique and self-assembling peptide

Multicenter randomized controlled trial of primary endoscopic hemostasis after endoscopic sphincterotomy between balloon tamponade technique and self-assembling peptide - PPAP trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs052230103

Enrollment

130

Registered

2023-09-22

Start date

2023-09-22

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

Performance status 0 to 3 Bleeding, Endoscopic sphincterotomy, Endoscopic retrograde cholangiopancreatography, PuraStat

Interventions

Randomized controlled trial

D016449

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Oozing bleeding after EST Age >18 yo Obtaining informed consent

Exclusion criteria

Exclusion criteria: Pulsatile, and projectile bleeding after EST Past history of undergoing EST Patients with surgical altered anatomy ASA 3 ECOG PS 4 Patients with a history of hypersensitivity to peptide or protein preparations Patient's refusal to attend study Patient who are judged to be inappropriate for attending study by the investigator

Design outcomes

Primary

Measure	Time frame
Technical success rate of endoscopic hemostasis	—

Secondary

Measure	Time frame
Severity of EST bleeding Procedure time	—

Contacts

Public ContactAtsushi Okuda

Osaka Medical and Pharmaceutical University Hospital

atsushi.okuda@ompu.ac.jp+81-72-683-1221

Outcome results

None listed

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