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Efficacy and safety of polysaccharides Hemostatic Powder in exudative bleeding after endoscopic sphincterotomy: A randomized controlled clinical trial

Efficacy and safety of polysaccharides Hemostatic Powder in exudative bleeding after endoscopic sphincterotomy: A randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092280
Enrollment
Unknown
Registered
2024-11-13
Start date
2023-09-10
Completion date
Unknown
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post-EST bleeding

Interventions

experimental group:Hemostatic powder
control group:Hemostatic Clip

Sponsors

Beijing Friendship Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Aged between 18 and 80 years old (2) Patients undergoing ERCP for malignant biliary obstruction, cholangitis, or choledocholithiasis and who are likely to have exudative bleeding after the proposed intraoperative EST dissection

Exclusion criteria

Exclusion criteria: (1) Subjects who do not personally consent to participate in this clinical trial (2) Patients with arterial bleeding after EST incision (3) Patients with coagulation disorders or thrombocytopenia, presence of platelets 1.5x normal value or INR >2.5 (4) patients with organ dysfunction (5) Patients who are unable to discontinue antiplatelets or anticoagulants (except acetylsalicylic acid) (6) Patients with confirmed pregnancy or breastfeeding (7) Allergic reactions to study materials (8) Suspected active preoperative gastrointestinal bleeding (9) Difficulty in accessing Vater's potbelly endoscopically (10) Patients enrolled in other clinical trials within four weeks

Design outcomes

Primary

MeasureTime frame
Hemostatic success in immediate post-EST exudative bleeding;

Secondary

MeasureTime frame
Incidence of delayed bleeding after successful hemostasis of the first exudative hemorrhage;Overall treatment failure rate;Further intervention methods;Incidence of adverse events;Duration of hemostasis;Duration of operation ;

Countries

China

Contacts

Public ContactPeng Li

Beijing Friendship Hospital, Capital Medical University

lipeng@ccmu.edu.cn+86 135 2113 6454

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026