Clinical trial NCT03903523: Efficacy and Safety of Lumen Apposing Metal Stents
Official title: Efficacy and Safety of Lumen Apposing Metal Stents: a Retrospective Multicentre Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Biliary Obstruction
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective analysis of a prospectively maintained database of all consecutive patients with distal malignat biliary obstruction, high surgical risk acute cholecystitis, or symptomatic pancreatic fluid collection that underwent EUS drainage from January 2016 to December 2022. All EUS drainage were performed by experienced operators.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Endoscopy Unit, Humanitas Research Hospital
state: Milano
city: Milano
country: Italy
facility: Humanitas Research Hospital
Study officials:
affiliation: Humanitas Research Hospital IRCCS, Rozzano-Milan
name: Andrea Anderloni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.