MedTrace Logo

Efficacy and Safety of Lumen Apposing Metal Stents

NCT03903523 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2022-09-14

No results posted yet for this study

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

DEVICE

Lumen apposing metal stent (LAMS)

Stent positioning

Sponsors & Collaborators

  • Istituto Clinico Humanitas

    lead OTHER

Principal Investigators

  • Andrea Anderloni, MD · Humanitas Research Hospital IRCCS, Rozzano-Milan

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-30
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03903523 on ClinicalTrials.gov