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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
114
* Ultrasonographic evaluation of the lesion by linear echoendoscope and positioning for transenteric puncture in shortest distance between enteric wall and the target lumen for drainage. * EUS-guided transenteric puncture by using a 19-gauge needle followed by placement of a 0.035 or 0.025-inch guidewire into the target lumen. * After the needle is removed in remaining the guidewire, the tract is dilated over the guidewire by using bougie dilator or needle type cystotome (Endoflex, Voerde, Germany). And then, the tract may be more dilated by using balloon catheter (4-mm). * After dilation of the tract, stent delivery system is inserted over the guidewire into the target lumen. * After complete deployment of the distal flange under EUS and fluoroscopic guidance into the target lumen, proximal retraction of the delivery system until the blue mark on the handle of the introducer is seen. And then, the proximal flange is deployed slowly under endoscopic guidance.
Chinese University of Hong Kong
Hong Kong, Hong Kong, China
Clinical success for pancreatic fluid collections
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.
Time frame: 8 hrs
Clinical success for acute cholecystitis
\- Afebrile for 8 hours, tolerating diet, absence of abdominal sign, or 20% decrease in white cell count.
Time frame: 8hrs
Clinical success for obstructive jaundice
\- A decrease in total bilirubin to \< 50 % of the pre-stenting value within 2 weeks.
Time frame: 2 weeks
Techincal success
\- Satisfactory access, placement of stent and drainage.
Time frame: 1 day
Adverse events
* 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
Time frame: 30 day
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