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

JRCT ID: jRCTs052230103

Registered date:22/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Performance status 0 to 3
• Date of first enrollment: 22/09/2023
• Target sample size: 130
• Study type: Interventional
• Intervention(s): Randomized controlled trial

Outcome(s)

• Primary Outcome: Technical success rate of endoscopic hemostasis

Secondary Outcome

Severity of EST bleeding
Procedure time

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Oozing bleeding after EST
Age >18 yo
Obtaining informed consent

Exclude 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

Related Information

• Primary Sponsor: Ogura Takeshi
• Secondary Sponsor: 3-D Matrix,Ltd.