None listed
Conditions
Interventions
Medical Device : 1. Patients diagnosed with a pancreatic pseudocyst through imaging studies such as computed tomography (CT), magnetic resonance imaging (MRI), or endoscopic ultrasound (EUS), and who
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults (aged 19 years or older), male or female, diagnosed with a pancreatic pseudocyst through CT, MRI, EUS, or other radiologic imaging modalities, and deemed to require endosonography-guided transmural drainage.
Exclusion criteria
Exclusion criteria: Exclusion Criteria (Any of the following conditions): Presence of a purely necrotic solid mass without any fluid component within the cyst Suspected cystic neoplasm or pancreatic cancer Presence of a bleeding disorder or coagulopathy (e.g., disseminated intravascular coagulation [DIC]), or a platelet count 1.5 Inability to discontinue anticoagulant or antiplatelet therapy Hemodynamic instability (e.g., shock) Pregnant or unable to use appropriate contraception in women of childbearing potential Psychiatric illness or condition that precludes participation in the study (e.g., dementia, seizure disorder) Inability to provide informed consent Any other condition in which the investigator deems the Tornado™ stent procedure to be inappropriate or not feasible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technical success;Adverse event | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical success;Stent patency period;Success of stent removal | — |
Countries
Korea, Republic of
Contacts
Public ContactWOO HYUN PAIK
Seoul National University Hospital
Outcome results
None listed