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NCT03903523 Clinical Trial

Efficacy and Safety of Lumen Apposing Metal Stents

Biliary Obstruction Clinical Trial

— LAMS  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03903523
Other study ID # 970
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 30, 2019
Est. completion date December 31, 2023

Study information
Verified date September 2022
Source Istituto Clinico Humanitas
Contact Andrea Anderloni, MD
Phone 0039-02-82247308
Email andrea.anderloni@humanitas.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age =18 years - Patients with distal malignant common bile duct obstruction with failed ERCP - Patients with symptomatic peripancreatic fluid collections - Patients with acute cholecystitis who are unfit for surgery - Agree to receive follow up phone calls - Able to provide written informed consent Exclusion Criteria: - Coagulation and/or platelets hereditary disorders. - Pregnant women - Inability to sign the informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Lumen apposing metal stent (LAMS)
Stent positioning

Locations
Country Name City State
Italy Humanitas Research Hospital Milano
Italy Endoscopy Unit, Humanitas Research Hospital Rozzano Milano

Sponsors (1)
Lead Sponsor Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate the rate of technical and clinical success of EUS drainage (gallbladder drainage, biliary drainage, peripancreatic fluid collection drainage) with the positioning of lumen apposing metal stents 6 years
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