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

The Chinese University of Hong Kong

Status

Completed

Conditions

Pancreatic Necrosis

Biliary Obstruction

Pancreatic Pseudocyst

Acute Cholecystitis

Treatments

Device: EUS-guided drainage

Study type

Interventional

Funder types

Other

Identifiers

SPAXUS version 3.0

Details and patient eligibility

About

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

Full description

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.

Enrollment

114 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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).