NCT03002051

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

EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent for the Management of Pancreato-biliary Diseases: a Multi-national, Multicenter Prospective Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Pseudocyst
• Pancreatic Necrosis
• Biliary Obstruction
• Acute Cholecystitis

Interventions

Type	Name	Description
DEVICE	EUS-guided drainage	* 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.

Timeline

• Start date: 2016-10-01
• Primary completion: 2018-10-01
• Completion: 2019-05-01
• First posted: 2016-12-23
• Last updated: 2019-12-13

Locations

1 site across 1 country: China