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Efficacy and Safety of Lumen Apposing Metal Stents

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03903523
Acronym
LAMS
Enrollment
500
Registered
2019-04-04
Start date
2019-04-30
Completion date
2023-12-31
Last updated
2022-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Obstruction

Brief 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.

Interventions

Stent positioning

Sponsors

Istituto Clinico Humanitas
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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 stents6 years

Countries

Italy

Contacts

Primary ContactAndrea Anderloni, MD
andrea.anderloni@humanitas.it0039-02-82247308
Backup ContactAlessandro Fugazza, MD
alessandro.fugazza@humanitas.it0039-02-82247021

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026