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

Phase 3

Recruiting

• Conditions: Performance status 0 to 3; Bleeding, Endoscopic sphincterotomy, Endoscopic retrograde cholangiopancreatography, PuraStat; D006470

• Registration Number: JPRN-jRCTs052230103
• Lead Sponsor: Ogura Takeshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-22
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Oozing bleeding after EST
Age >18 yo
Obtaining informed consent

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical success rate of endoscopic hemostasis

Secondary Outcome Measures

Name	Time	Method
Severity of EST bleeding<br>Procedure time