None listed
Conditions
Interventions
Medical Device : In patient with bleeding during EST or endoscopic papillary, CGGEL, a powdered hemostatic agent, is sprayed onto the bleeding site in the experimental group. And a diluted epinephrine
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult over 19 years old 2. A person who shows endoscopic bleeding or is expected to bleed during an endoscopic sphincterotomy or endoscopic papillectomy for the treatment of pancreatic or biliary tract disease* * pancreatobiliary diseases: AoV adenoma, bile duct stone, cholangitis, cholecystitis, sphincter of Oddi dysfunction, choledochal cyst, benign and malignant biliary strictures, acute/chronic pancreatitis, bile leakage, primary sclerosing cholangitis, primary biliary cholangitis 3. A person who is able to comply with the clinical trial requirements 4. A person who is able to give written informed consent prior to the clinical trial start
Exclusion criteria
Exclusion criteria: 1. Coagulopathy or Hemostatic disorder (platelet 1.5) 2. Active organ failure 3. Those who cannot stop taking antiplatelet drugs or anticoagulants 4. Those who have received/received other investigational drugs or medical devices within 4 weeks of screening 5. Pregnant or breast-feeding women 6. Those who have hypersensitivity to investigational medical devices or components 7. Those who are considered not suitable for the clinical trial by investigator 8. Those with active gastrointestinal bleeding or difficulty accessing the Ampulla of Vater through an endoscope 9. Those who did not have endoscopic bleeding on the day of endoscopic procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemostasis rate for immediate bleeding | — |
Secondary
| Measure | Time frame |
|---|---|
| hemostasis rate for delayed bleeding | — |
Countries
Korea, Republic of
Contacts
Public ContactSang Hyub Lee
Seoul National University Hospital
Outcome results
None listed