Study Results
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Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2019-04-30
2023-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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Lumen apposing metal stent (LAMS)
Stent positioning
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnant women
* Inability to sign the informed consent
18 Years
ALL
No
Sponsors
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Istituto Clinico Humanitas
OTHER
Responsible Party
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Principal Investigators
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Andrea Anderloni, MD
Role: PRINCIPAL_INVESTIGATOR
Humanitas Research Hospital IRCCS, Rozzano-Milan
Locations
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Endoscopy Unit, Humanitas Research Hospital
Rozzano, Milano, Italy
Humanitas Research Hospital
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Andrea Anderloni, MD
Role: primary
References
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Binda C, Anderloni A, Fugazza A, Amato A, de Nucci G, Redaelli A, Di Mitri R, Cugia L, Pollino V, Macchiarelli R, Mangiavillano B, Forti E, Brancaccio ML, Badas R, Maida M, Sinagra E, Repici A, Fabbri C, Tarantino I. EUS-guided gallbladder drainage using a lumen-apposing metal stent as rescue treatment for malignant distal biliary obstruction: a large multicenter experience. Gastrointest Endosc. 2023 Nov;98(5):765-773. doi: 10.1016/j.gie.2023.06.054. Epub 2023 Jun 29.
Fugazza A, Fabbri C, Di Mitri R, Petrone MC, Colombo M, Cugia L, Amato A, Forti E, Binda C, Maida M, Sinagra E, Repici A, Tarantino I, Anderloni A; i-EUS Group. EUS-guided choledochoduodenostomy for malignant distal biliary obstruction after failed ERCP: a retrospective nationwide analysis. Gastrointest Endosc. 2022 May;95(5):896-904.e1. doi: 10.1016/j.gie.2021.12.032. Epub 2022 Jan 4.
Facciorusso A, Amato A, Crino SF, Sinagra E, Maida M, Fugazza A, Binda C, Coluccio C, Repici A, Anderloni A, Tarantino I, Fabbri C; i-EUS Group. Definition of a hospital volume threshold to optimize outcomes after drainage of pancreatic fluid collections with lumen-apposing metal stents: a nationwide cohort study. Gastrointest Endosc. 2022 Jun;95(6):1158-1172. doi: 10.1016/j.gie.2021.12.006. Epub 2021 Dec 18.
Other Identifiers
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970
Identifier Type: -
Identifier Source: org_study_id
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