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