Efficacy and Safety of Lumen Apposing Metal Stents

Last updated: September 13, 2022
Sponsor: Istituto Clinico Humanitas
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gall Bladder Disorders

Treatment

N/A

Clinical Study ID

NCT03903523
970
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Coagulation and/or platelets hereditary disorders.
  • Pregnant women
  • Inability to sign the informed consent

Study Design

Total Participants: 500
Study Start date:
April 30, 2019
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • Endoscopy Unit, Humanitas Research Hospital

    Rozzano, Milano 20089
    Italy

    Active - Recruiting

  • Humanitas Research Hospital

    Milano, 20089
    Italy

    Site Not Available

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