NCT03903523

Efficacy and Safety of Lumen Apposing Metal Stents

Efficacy and Safety of Lumen Apposing Metal Stents: a Retrospective Multicentre Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Endoscopic ultrasonography (EUS) has revolutioned the management of gastroenterological patients and is acquiring an increasingly important role. The development of specifically designed stents has significantly increased the technical and clinical success rate of the EUS-guided procedures, considerably reducing the rate of adverse events. Currently EUS has a prominent role in drainage of peripancreatic fluid collections and it represents an important therapeutic option for patients with distal malignant biliary obstruction, in which the ERCP fails, allowing the positioning of a transgastric or transbulbar lumen apposing metal stent (LAMS) to drain the biliary duct. Moreover, the EUS-guided gallbladder drainage of patients with high surgical risk and acute cholecystitis, which cannot be operated, is another important therapeutic indication. Our aim is to perform a multicentre retrospective analysis of all types of EUS drainage (gallbladder drainage, biliary drainage, peripancreatic fluid collection drainage) with the positioning of LAMS in order to evaluate the rate of technical and clinical success and to assess the safety profile of these procedures.

Conditions

• Biliary Obstruction

Interventions

Type	Name	Description
DEVICE	Lumen apposing metal stent (LAMS)	Stent positioning

Timeline

• Start date: 2019-04-30
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2019-04-04
• Last updated: 2022-09-14

Locations

2 sites across 1 country: Italy