Brief Title
EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent
Official Title
EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent for the Management of Pancreato-biliary Diseases: a Multi-national, Multicenter Prospective Study
Brief Summary
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
Detailed 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.
Study Type
Interventional
Primary Outcome
Clinical success for pancreatic fluid collections
Secondary Outcome
Techincal success
Condition
Pancreatic Pseudocyst
Intervention
EUS-guided drainage
Study Arms / Comparison Groups
EUS guided drainage
Description: Patients suffering from the conditions in focus would receive EUS guided drainage with the lumen apposing stent
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
114
Start Date
October 2016
Completion Date
May 2019
Primary Completion Date
October 2018
Eligibility Criteria
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).
Gender
All
Ages
20 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Anthony Teoh, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03002051
Organization ID
SPAXUS version 3.0
Responsible Party
Principal Investigator
Study Sponsor
Chinese University of Hong Kong
Collaborators
SoonChunHyang University School of Medicine
Study Sponsor
Anthony Teoh, Principal Investigator, Chinese University of Hong Kong
Verification Date
December 2019