EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent

EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent for the Management of Pancreato-biliary Diseases: a Multi-national, Multicenter Prospective Study

To evaluate clinical efficacy and safety of a novel lumen-apposing FCSEMS for EUS-guided transenteric drainage of PFC or of biliary tree including GB

Patients with the following conditions would be recruited for drainage under EUS guidance with the new lumen apposing FCSEMS

• Symptomatic or infected pancreatic pseudocyst or walled-off necrosis (WON) (SPAXUS 16 or 10 mm)
• Acute cholecystitis by inoperable malignant diseases (SPAXUS 10 mm)
• Acute cholecystitis by benign conditions with high-risk for operation (SPAXUS 10 mm)
• Long-term cholecystostomy at high-risk for operation (SPAXUS 10 mm)
• Symptomatic malignant obstruction of the distal CBD with unsuccessful transpapillary approach (the diameter of the CBD > 10 mm) (SPAXUS 8 or 10 mm)

Outcome paramaters include technical and clinical success, adverse events.

Inclusion Criteria:

Patient must meet all of the following inclusion criteria to be eligible for enrollment into the study.

• Pancreatobiliary diseases that are eligible for EUS-guided transenteric drainage
• The patient who aged from 20 to 80 years. Legally acceptable representative must be capable of giving written informed consent prior to participation in this study
• Target lesion that is accessible through the transenteric approach
• The woman of child-bearing age must be negative from the pregnancy test in order to participate in this study
• The patient who is willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures
• The patients should not have any unacceptable conditions (e.g., physiological, familyism, social, geographical) for medical follow-up and adaptation of the study.

Exclusion Criteria:

Patient presenting with any of the following will not be included in the study.

• Inaccessible to EUS-guided approach
• Bleeding tendency: International normalized ratio (INR) of prothrombin time < 1.5 or platelet conunt < 60,000/mm3
• Patients with Disseminated Intravascular Coagulation syndrome(DIC)
• Patients who have been taking medicines that can cause hemorrhage (e.g., Aspirin, Wafarin etc.)
• Patients with other serious disease or medical condition
• Patients with past medical history of significant neurologic or Psychiatric disorders such as dementia or seizure
• Unstable heart disease despite of treatment, recent myocardial infarction within 6 month (Even though MI was diagnosed within 6 months, if it becomes stable presently, the patient can be possible to participate).