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

Not Applicable

Completed

• Conditions: Pancreatic Pseudocyst; Acute Cholecystitis; Pancreatic Necrosis; Biliary Obstruction
• Interventions: Device: EUS-guided drainage

• Registration Number: NCT03002051
• Lead Sponsor: Chinese University of Hong Kong

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 Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-12-16
• Study First Submitted QC: 2016-12-20
• Study First Posted: 2016-12-23
• Primary Completion: 2018-10
• Study Completion: 2019-05
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-12
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EUS guided drainage	EUS-guided drainage	Patients suffering from the conditions in focus would receive EUS guided drainage with the lumen apposing stent

Primary Outcome Measures

Name	Time	Method
Clinical success for pancreatic fluid collections	8 hrs	① Clinical success of pancreatic fluid collections; * Peudocyst: resolution more than 50% in the initial size of cyst.; * Walled-off necrosis: resolution of PFC without the need for additional interventions after endoscopic interventions.
Clinical success for obstructive jaundice	2 weeks	- A decrease in total bilirubin to \< 50 % of the pre-stenting value within 2 weeks.
Clinical success for acute cholecystitis	8hrs	- Afebrile for 8 hours, tolerating diet, absence of abdominal sign, or 20% decrease in white cell count.

Secondary Outcome Measures

Name	Time	Method
Techincal success	1 day	- Satisfactory access, placement of stent and drainage.
Adverse events	30 day	* Bleeding: any hemorrhagic event during or after the procedure that required endotherapy, radiological interventions, blood product transfusion, or inpatient observation.; * Perforation: perforation of the GI tract or cystic wall on imaging studies with peritonitis signs.; * Pneumoperitoneum or pneumoretroperitoneum: intraperitoneal or retroperitoneal air on imaging study.; * Stent migration: dislocation of the stent into the lumen or the GI tract on imaging study

Trial Locations

Locations (1)

Chinese University of Hong Kong; 🇨🇳 Hong Kong, Hong Kong, China