Clinical trial NCT03002051: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Pseudocyst
Pancreatic Necrosis
Biliary Obstruction
Acute Cholecystitis
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: SoonChunHyang University School of Medicine
First posted: 2016-12-23
Enrollment: 114
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Clinical success for pancreatic fluid collections
timeFrame: 8 hrs
measure: Clinical success for acute cholecystitis
timeFrame: 8hrs
measure: Clinical success for obstructive jaundice
timeFrame: 2 weeks
Secondary outcomes:
measure: Techincal success
timeFrame: 1 day
measure: Adverse events
timeFrame: 30 day
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Chinese University of Hong Kong
state: Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Anthony Teoh
role: PRINCIPAL_INVESTIGATOR
References:
citation: Teoh AYB, Kongkam P, Bapaye A, Ratanachu T, Reknimitr R, Lakthakia S, Chan SM, Gadhikar HP, Korrapati SK, Lee YN, Medarapalem J, Ridtitid W, Moon JH. Use of a novel lumen apposing metallic stent for drainage of the bile duct and gallbladder: Long term outcomes of a prospective international trial. Dig Endosc. 2021 Nov;33(7):1139-1145. doi: 10.1111/den.13911. Epub 2021 Jan 11.